ML19324B683
| ML19324B683 | |
| Person / Time | |
|---|---|
| Site: | 05000470 |
| Issue date: | 10/31/1989 |
| From: | ABB COMBUSTION ENGINEERING NUCLEAR FUEL (FORMERLY |
| To: | |
| Shared Package | |
| ML19324B682 | List: |
| References | |
| PROJECT-675A CENPD-210-01, CENPD-210-1, CENPD-210-R05, CENPD-210-R5, NUDOCS 8911080005 | |
| Download: ML19324B683 (92) | |
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Enclosure III !
(66 Pages) l I
i NUCLEAR POWER BUSINESSES CENPO 210 u
QUALITY l L,
ASSURANCE l PROGRAM l A Description of the !
i Nuclear Power Businesses Quality Assurance Program l I
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REVISION 5, OCTOBER 1989 8911080005 891030
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i A3STRACT f
I vc This report ooscribes the quality assurance prusram employed by the !
Nuclear Power Busiaesses Division of Cer.bustion, Inc., for the supply of items and services sutject to the requirementi of 10CFR50, Appendix B. l The program is based on and is responsive to the requirements of (
ANS!/ASME NQA-1. " Quality Assurance Program Requirements for Nuclear [
Facilities (1983 Edition with Addenda la (1983))"; the ASME Boiler and !
t Pressure Vessel Code Section !!!, Nuclear Power Plant Components (1986 Edition), and the guidance in Regulatory Guide 1.28 " Quality Assurance l Program Requirements (Design and Construction)" (Rev. 03). !
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i l Table of Contents ;
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I 111.1 Pace No, Caver Sheet i .
L' Abttract ii !
[ Table of Con *ent4 iii ,
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- 1. Introduction 1 i l [
II. Nuclear Dower ')usinessoa Quality Policy 2 f i
t 111. Quality Assurance Criteria 4 !
!!!.1 Organization 4
!!1.2 Quality As'.urance Program 6 l 111.3 Design Control 8 I
!!!.4 Procurement Cocument Control 16 !
III.5 Instructiens Procedures and Drawings 18 f
111.6 Document Control 19 !
!!!.7 Control of Purchased Items trid Services 20 l 111.8 Identification and Control of Items 23 ;
III.9 Control of Processes 23 !
111.10 Inspection 24 [
Ill.11 Test Control 25 3
111.12 Control of Measuring and Test Equipment 27 ;
111.13 Handling, Storage and Shipping 28 :
!!!.14 Inspection Test and Operating Status 29 f
!!!.15 Control of Nonconforming Items 29 f
III.16 Corrective Action 30
!!!.17 Quality Assurance Records 31 :
!!!.18 Audits 32 !
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l Table of Contents (Continued) ,
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!!-1 Organizatice Chart-Nuclear Quality Systems 35 l II-2 Organization Chart Nuclear Power Businesses 36 l Tables I
Table No. Title Pace No, j i
!!!-1 Responsibilities of Nuclear Quality Systems 37 t
III-2 Responsibilities of Nuclear Power Businesses 38 l Business Units
!!!-3 Clarifications to NQA-1 and/or 39 Regulatory Guide 1.28 (Rev. 03) l
!!!-4 Typical List of Quality Assurance' Procedures 40
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p-I. INTRODUCTION i
I.1 hirDose This report d ncribes the quality stsurance progrWe employed by
the Nucloer Power Businesses Division of Combustion Ergineering, Inc., for the supply of items and services subject to the requirements of 10CFR50, Appendix 9.
! !.2 Scope !
l This rscort includes a description of controls employed at the l Nuclear Powar Businesses (NPB) facilities noted below. Section l
!! presents the NPB commitment to quality and describes the NPB quality assurance organization and responsibilities. Section j III describes the quality assurance controls employed to
- address each criterion of 10CFR50, Appendix B. The controls -
apply to all NPB facilities unless otherwise indicated. j I
The NPB facilities and the activities involved at each facility l include Facility Activities l l
NPB Headquarters, Engineering services and NSSS !
Windsor, CT (with design, procurement, testing, ,
offices also in inspection, repair, insta11aticn, l
Chattanooga, TN) and spare carts Nuclear Fuels Manufacture of nuclear fuel i
Manufacturing, pellets, fuel assemblies and Windsor, CT and control element assemblies and ;
Hematite, M0 associated activities t
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E l-C-E Controls / Electro- Design and manufacture of Mechanics, New instrumentation & control Britain, CT and systems and associated activities Windsor, CT C E Newington, Design and manufacture of g Newington, NH mechanical systems and assortitud activities l l
1.3 Revision Control [
I Revisinns to this report will be in accordance with the standards specified in 10CFR50.55 (f) (3). Specifically; j l
o within 90 days, NRC will be informed of changes to this '
program that do not reduce previously accepted commitmentsI f o changes that reduce commitments will be submitted for l NRC approval prior to implementation. !
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!!. NUCLEAR POWER BUSINESSES OVALITY POLICY j
!!.1 Policy Statement f The President, Nuclear Power Businesses, has authorized the l following statement concerning Quality f
assurance policy: .
i "A primary objective of Nuclear Power Businesses is to deliver ,
to our cur.tomers 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 NPB quality assurance program f l
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r and shall, bring to the attention of the President, Nuclear Power Businesses any quality problem that cannot be resolved within the normal execution of this responsibility".
6 11.2 Qgt1tyAssuranceOrganization 1
The Quality Assurance (QA) organization in NPB is shown in Figure !!-1.
The Vice Prasident, Nucient Que.lity Syste.ms (NQS) is responsible to assure tnat the QA policy, goals and otjectives art trantmittod thrcugh lesels of management and imposed on quality functions. This is accomplished by distribution of Quality Assurance Manuals which contain QA policy statements.
Responsibility for nuclear quality assurance rests with the President, Nuclear Power Businesses and is delegated to the Vice President, Nuclear Quality Systems, who may further delegate specific activities to NQS personnel.
Such delegation includes authority to stop work for noncompliance to requirements. Stop work orders are dispositioned by NQS and may be originated at sny organization level and unit in NPB 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.
Compliance with quality requirements is measured through planned surveillance and/or audit activities and corrective action follow-up by NQS personnel. NQS is independent of other organizations within NPB as shown in Figure !!-2. NQS interprets quality related industry standards for intent and guidance and is responsible for assuring that all quality assurance related procedures used in NPB comply with established QA requirements.
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III. QUALITY ASSURANCE CRITERIA i- This section describes each of the eighteen (18) elements of the Combustion Engineering, Inc., Nuclear Power Businesses Division quality assurance program.
III. 1 preenization Combustion Engineering, Inc., (C E) has corporate headquarters at Stamford, Connecticut, and is a diversified energy systems and services company. It centains several divisions, one of which is Nuclear Power Businesses. The President, Nuclear Power Businesses Division (NPB) is responsible for the supply of nue, lear systems, nuclear fuel and nuclear servir.es. QA responsibilities originate within NPB as. illustrated in Figures 11-1 and 11-2. NPB is headquartered at 1000 Prospect Hill Road, Windsor, Connecticut 06095.
Each project under contract at NPB is coordinated 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 documenting all project work, assuring conformance with contract requirements and maintaining communication channels among NPB, the customer, and all other I participating organizations.
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h The Vice President, Nuclear Quality Systems (NQS) reports at the same organizational level as other NPB Vice Presidents. ;
Responsibilities of NQS are listed in Table 111-1. These ;
responsibilities are carried out through the NQS staff (Figure
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II-1) .and by coordination of all QA activities within NPB.
Details on responsibilities and interfaces among NQS and other l organizations are contained in QA manuals and procedures. !
These interface relationthips andress items such as auditing, l r
5 investigation of quality problems, and implementation of j corrective action. Responsibilities of the other NPS units are listed in Tsble !!!-2. ;
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NQS functions as an independent communication channel between- i senior NPB management and line management. This assures that ;
senior NPB management is appraised of quality matters and that the NQS staff receive and comply with directives from the ;
President, Nuclear Power Businesses via the Vice President, i Nuclear Quality Systems. }
The Vice President, Nuclear Quality Systems meets as necessary ;
and at least monthly with the NQS management staff to discuss ;
quality issues, schedule cuality efforts, establish goals and !
identify areas for improvements. These meetings are i supplemented by reports from the NQS management staff to the Vice President, NQS and from the Vice President, Nuclear ;
Quality Systems to the President, Nuclear Power Businesses. ;
The detailed organizational structure of NQS as well as the :
number of personnel in NQS may change over time depending on ;
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 matters, s
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v NQS personnel selection is Sased on knowledge of NPB !
operations; QA regulations, practices and standards; past [
working experience in QA or related activities in nuclear j power or a similar high technology industry and education !
considerations. In addition, NQS management assignments are i also based on evtluated management experience in similarly i responsible positiens.
III.2 Quality Assurance program 111.2.1 Summary Description The QA program described herein is employed by NPB for the l supply of items and services subject to the recuirements ,
of 10CFR50 Appendix B. The program ia 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)". Alternatives to the explicit requirements i and guidance given in NQA-1 and/or Regulatory Guide 1.28 are described in Table III-3.
III.2.2 program control ;
I The requirements of this program are implemented at each NpB facility through QA manuals and procedures applicable ,
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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h III.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 President, Nuclear Power Businesses receives a monthly report from the Vice President, Nuclear Quality Systems covering major quality issues such as: significant internal and customer audit findings, industry quality-related deve'iopments, '
and quality improvement n6sds. Quality issues and assessments ar discussed during r& gular staff meetings with the Vice presidants involved. The Vice president, Nuclear Quality Systems is assessed, at least anr.ually, for the performance of the QA program by the President, Nuclear Power Businesses through a documented management appraisal system.
111.2.4 personnel Indoctrination and Trainino The responsibility for assuring that oorsonnel performing activities affecting quality are suitably trained rests with the organization performing those activities. Detailed personnel training requirements for each NPB facility are contained in QA procedures. NQS is responsible for assurir.g 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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l o indoctrination in the purpose, scope and implementation j of QA manuals, and applicable instructions and procedures l through self-study, l
o proficiency tests and/or performance reviews, and/or on-the-job observations as determined by management, to ,
determine adequacy of training and qualification, [
J! l o maintenance of proficiency by performance review, ;
'i - and/cr reexamination, ind/or retraining as determined by management. ;
Indoctrination, training and qualification of NQS personnel !
verifying quality - affecting activities consir.ts of the three i items above anc in addition the following:
I o training and qualification in the principles, techniques
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and requirements of the activity being performed. !
Documentation for these formal programs normally include f
the program objective, content, attendees, date(s) of the l training or certification, and appropriate approvals. I l
For all of the above, training and qualification is documented f in certificates and/or procedures that delineate the specific I functions personnel are qualified to perform as well as the i basis for the qualification.
111.3 DESIGN CONTROL
!!!.3.1 General Quality assurance procedures are used to assure that design activities are carried out in a planned, controlled and timely i manner and that applicable design requirements are established 5 and correctly translated into design documents such as calculations, specifications and drawings.
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l These procedures provide specific instructions for accomplishment of .j design activities by defining requirements for design inputs and
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outputs including: )
o document format and content, o document identification. {
o review and approval, I o design verification, o issuance and distribution. l o revision control, !
o indication of document status, ;
o record retention. l f
The procedures apply to design / engineering activities including such disciplines as reactor physics; stress, thermal, hydraulic and l' accident analyses; compatibility of materials; accessibility for ,
inservice inspection, maintenance and repair; fuel design; !
instrumentation and controls design; and delineation of acceptance j criteria for inspections and tests.
f 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 f for suitability of application and compatibility with l overall system design criteria; ,
o design interfaces among participating organizations ,
internal and external to NPB are identified and controlled; ;
o design work is verified or checked for adequacy; o design changes, including field changes, are subject to the [
same degree of control ss applied to the original work.
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Compliance to design control procedures is monitored by NQS internel compliance audits.
!!!.3.2 Desian inputj, Design work begins with the definition of the design requirements or design bases information. 1hese requirements come from severs 1 sources internal and external to NPB.
Typical sources include previously approved designs, those from engineering and product development efforts, contracts (eg., equipment performance criteria, design life, regulatory requirements, codes and standards, interface reoutrements, etc.), Standaad Safety Analysis Reports, topical report, 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 industry standards as apolicable 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 cesign inputs including the identification, substantiation, and documentation of changes from previously approved designs.
The C0 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 referent.e to the source of the data.
Design documents containing input data are aporoved by the author and verifier (s) of the documents.
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!!!.3.3 Desian Calculations f The C0 is responsible for selection of input data and analysis !
method, justification of assumptions, and preparation of f design calculations.
i Documentation of design calculations is detailed in purpose. (
- method, assumptions, design input, references and units so ,
that a person technically qualified in the subject can review l' and understand the design and verify the results without recourse to the originator. !
Computer codes (used in design analyses or supplied to l
clieqts) are uniquely identified, tested and verified to l assure accuracy of method. Procedures are used to preclude j use of unverified modifications. Sample problems used in the [
verification are retained as records and include unique l
identification of the version of the computer code and j documentation of inputs and outputs. Evidence of testing and i verification of a given version of a computer code is f documented and includes the signature of the author and f verifier (s) of the code testing documentation. Dissemination [
of information on computer code errors is provided via a j computer program error notification system. Computer source f codes are protected by security methods to preclude {
unintentional, unplanned or unauthorized modifications, j A qualified Individual or group is t.ssigned to verify the [
design work (see 111.3.7, Design Verification). When a j standardized or previously proven design is used, the {
verification process is not duplicated, however, the ,
applicability of the standardized design is checked with j respect to meeting pertinent inputs.
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The cover sheet or revision page of the document includes l piovisions for unique identification and the signatures of the i j author (s) and verifier (s). l 111.3.4 Desian Specifications .
5 The C0 is responsible for the preparation of design specificatioas. These specifications contain a complete basis ,
for construction of items in accordance with the requirements I of the ASME Code, contractual documents, regulations, and !
other applicable information, and in conjunction with design l
drawings, contain all necessary information regarding j materials and design. A design specification includes: l l
o functions and boundaries of the items covered, o the design requirements including all r64uired f
uverpressure protection requirements, l o the environmental conditions including radiation, i o the safety classification of the items covered, ;
o material requirements including impact test !
requirements, f o operability requirements as appropriate, j o the effective ASME Code Edition, Addenda and Cases and other ;
appropriate industry standards to be used for construction. l o records required to be maintained, o special inspection, testing, and Quality assurance :
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i A qualified individual or group is assigned to verify the '
specification (see 111.3.7, Design Verification). The cover !
sheet or revision page of the document includes provisions for I unique identification and approvals of the author and i verifier (s). <
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l The C0 is responsible for the preparation of design drawings. [
These drawin;; 4clude functional requirements for j system / component interi2*es, arrangement and layout, which are l not directly used for produe'ng an item. Examples include: !
piping and instrument diagrams, layout drawings, general I arrangement drawings, and electrical diagrams. A drawing t request system is used to define the scope and purpose for the f drawing, the 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 !
calculations, analyses, or other applicable design [
specification requirements. Additicnally, a qualified ,
individual or group is assigned to verify the contents of the drawing (see !!!.3.7, Design Verification). f I
i III.3.6 Other Desian Documents The CO L responsible for preparation of other design documents [
needed to define er describe engineering requirements. These [
documente typically include items such as: design bases or design data information; system descriptions; interface l requirements; test requirements; guidelines for startup and I 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 III.3.7. Design Verification). The co9er sheet or :
revision page of the document includes provisions for unique !
identification and approvals by the author and verifier (s).
111.3.7 Desian 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. ,
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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 C0 competent to perform the verification and pt'evided' l
o the supervisor did not specify the design approach, and l did not rule out certain design considerations, f o the supervisor did not establish the design input.
Audits by NQS address the use of supervisors as design veriftsrs to guard against abusg. !
The C0 determines the particular design verification rathod(s) i to be used and designates the individual or group responsible ;
for the verification efforts. The acceptable verification methods include design reviews, alternate calculations, and !
Qualification testing and are defined as follows:
o Design Reviews - independent review to assure that the l information is correct and satisfactory, i
o Alternate Calculations - preparation of calculations or l analyses using alternate methods to verify by comparison {
the correctness of the original work. f o Qualification Testing - suitable testing of a model, ;
prototype or initial production unit.
Qualification testing (as opposed to acceptance testing) is j 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 C0 to assure that test i
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requirements have been met. When tests are being performed on models or mockups, scaling laws are established and verified and results are subject to error analysis when applicable
!# prior to use in final design work.
Design Verification procedures address responsibilities of verifiers, items to be verified and documentation required.
Results of the verification are documented, including identification of the verifier (s). Design verification is completed prier to relying upon the component, system, part er structure to perform its tafety related function.
!!!.3.8 Revision Control Design document revisions are subject to the same review, approval ano distribution controls as those applied to the original work. Revision 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 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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!!!.3.9 interface Control !
Quality assurance procedures contain the organizational f
structure within which the program is implemented and delineate !
the authority and responsibility of the C0's involved. The
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organizational interfaces among contributing C0's, both i internal and external to NPB, are controlled in accordance with these procedures, i I
Three procedures control the flow of design information by '
requiring the formal release of outputs involving interface information to other functional groups. This is ac;omplished within NPS by documented correspondence or standard document f' distribtuion forms and external to NPS by letters or approvsd ,
procurement documents. The transmittal identifies the f verification status of the information or cocumer.t and, where ;
necessary, identifies incomplete items which recuire further !
verification. Where it is necessary to transmit desipn j information orally or by other informal means, follow-up by a !
controlled document is provideo. Interface communications are f
traceable from a request through a related response to assure completeness and accuracy.
t I!!.4 PROCUREMENT DOCUMENT CONTROL Controlled pr0cedures are used for the preparation, review and i
approval of procurement documents. Groups that prepare, review l
and approve procurement documents are identified in the !
procedures. These groups include design groups, (CO's per l
Section 111.3), procurement groues, and NQS.
Procurement documents ine'uJe (either directly or by reference) l t the following requirements, as applicable:
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o regulatory, ASHE Code and industry standards; I L o tests and inspections, including acceptance criteria; '
l o quality assurance program elements; :
1 o quality assurance records retention times and disposition; f o reporting, approving and dispositioning nonconformances' o rights of access by NP8 and/or its representative (s); j o documentation submittal, review and approval; [
o extension of requirements to sub-suppliars; !
o technical / design (including drawings and specifications); l; o administrative; and o special proconaing. !
It is the responsibility of the NPB organizat W that preoarea i the procurement document to assure that all required elements are addressed. Procurement documents are reviewed and appioved t.y personnel trained in QA procedures prior to issue.
Ttis approval is also 20plicable to supplement's issue:d to ;
change the requirements c# th original precurement. !
i The procurement process for commarcial-gradeU ) items and f services uses the same review and approval r.ycle. Thes6 are l bought to commercial standards where standards are available. i Commercial items that become part of a system may be tested as i part of the completed system. Procurement documents for i standard commercial or previouuly approved items including spare or replacement parts essential to the safety functions j of structures, systems, and components, are reviewed and approved by personnel trained in QA procedures, j i
f (1) Controls limited to those items and services to be subsequently '
dedicated by NPB as " basic components".
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111.5 !NSTRUCTION
S. PROCEDURE
S AND ORAWINGS l
- i Quality affecting activities such as engineering, f manufacturing, inspection, testing, certification, handling, ;
storage, shipping, etc., are prescribed by end performed in accordance witii documented instructions, procedures, or drawings of a type appropriate to the circumstances. Quality assurance procedures require that these documents include or j reference quantitative or qualitative acceptance criteria for
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The following is a sew.ary of the types of instructions, {
procedures, and drawings used to control quality affecting ;
activities.
0A Manuals, procedures ar# instructions - documents containing ,
the systems and procedures that specify and describe the l activities performed within NPB to provide adaquate confidence f
that an item or service a:ovided tasats applicable reouirements. :
A typical list of QA pr:cedures is given in Table III-4. l l
procurement Documents - documents that specify requirements for !
purchase of an item or service including purchase requisitions, l drawings, process or material specifications, procedures or instructions.
process Control Documents - documents that are used to control i 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. Examples 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, shippinc, handling, welding,
': brazing, heat treatment, and sWilar special processes.
I III.6 POCUMENT CONTROL l
Quality assurance crocedures art, used to assure current and ;
appropriate docurnents are used. These procedures control l issuance of instructiens, v ocedures, and drewings that specify f
quality requirements or that prescribe activities affecting l Quality. The procedures specify how documents are reviewed for !
adecuacy, approved for release, and distributed to and used at !
the location where the prescribed activity is performed.
These procedures address items such as: j l
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, ano those !
documents identified in Section !!!. 5; 1 i
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- j. o use of distribution lists or equivalent to assure that the j l ,
proper personnel or organizations are provided the required ;
- documents to perform the work; j I
o document identification to assure that the proper document !
is used in performing a particular activity. The l j identification includes the document number or any other [
relevant information that identify the document to be used; l t
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o ascertaining that proper documents are accessible and are i 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 aoolicable documents have been received and obsolete !
revisions rech11ed or discarded, where appropriate. !
Changes to docurmts are reviewed, approved, and released by the organizations responsible for the werk unless other organizations are sper.ifically designated. In all cases, the I reviewing organization (s) has access to pertinent infornation !
cr oar.kg'.'uund data upon which to base approvat.
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! ! ! .*i CONTROL _QFp9RCHASEDITEMSANDSERV!CE5 f Items and services are procured from approved suppliers. QA 1 procedures specify requirerents for supplier evaluation and {
selection, control of supplier generated documents, acceptance <
of the item or service (by documentation review, source l surveillance, source and/or receiving inspection), control of j nonconforming conditions, supplier performance evaluations ,
(assessments and audits), and qualification of NPB audit, inspection and surveillancs personnel. 3 l
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i When specified in' procurement documents, NPB performs surveillance of suppliers during fabrication, inspection, f testing, and release of items and services. Quality procedures l' provide guidance for surveillance activities. Where no established quality standards exist for a specific supplier, f the specific technical requirements of the procurement !
documents are used as the basis for surveillance. The degree i of surveillance varies with the degree of importance of ;
equipment, supplier performance, and complexity of items. The l degree of surveillance is decermined by the organizatien that [
prepared the order and by NQS. This surveillance is performed l using instructions which define the operation or process to be witnessed and the verifications to be made.
The procc Narnt of spart or red acements pr.rts and ccmponents are f,0verhed by customer order requirement 3. h l
r For commercial-grade items which are supplied as safety-related but tvhore spet:ific QA centect cu.not be imposed in a practical "
- runner, snecific p.aovisions are made during rectiving j inspection or source surveillance to verify that requirtrechts j of the procurement document have been met.
Initial supplier approval is via survey or evaluation that is conducted by NQS. The purpose of these are to verify that the l
new supplier is capable of complying with the quality j requirements in the procurement documents. The results are !
documented and any identified defd.ciencies are resolved prior i
to starting work, Supplier approval is maintained by annual evaluations and periodic audits. The annual evaluations take into ;
l consideration items such as supplier furnished documentation; results of prior surveillances, inspections, and audits; and -
item or ' service operating performance. The periodic audits are ,
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I normally performed on a triennial basis and are consistent with ;
the guidance in Regulatory Guide 1.28 (Rev. 3). The scope and l
frequency of aedits depends on many factors, such as those i given in Table 111-3. The audits address the applicable l criteria of 10CFR50 Appendix B. l I
Suppliers that have received ASME approval are approved on the l basis of the ASME approval, fp i
For items shipped to a NPB manufacturing or warehouse facility, j receiving and/or source surveillance procedures are used to assure that the item and specified documentation comply with the precurement document requirements. Measures are i established to assure that items accepted and released are !
identif hd as to their inspection status in order to prevent f the use or installation of non-acceptec items and provide for l
the entry only of accepted items into the varehouse. Thr j status is icentified no the item er on documentation tra cable l to the item. !
l Fer items pro;;u?ed by NPB ar.d shir. ped to a nuclear power plant site, NQS issues a cartificaticn which indicates hecsstance of {
the item. The certification includes specific informatien l
identifying the item and the applicable procuremt4nt documents, !
and certifies that the item meets all applicable procurement f I
requirements, including documentation requirements. The l certification includes identification of any NPB approved l deviations from the procurement requirements and is approved by '
authorized personnel. Procedures identify the actions l l necessary to initiate, authorize, issue, distribute, and revise ;
certifications. These procedures include provisions for review l and acceptance of supplier furnished documentation (e.g. j certificates of conformances, certified material test reports, non-destructive examination reports) and for identifying and following-up contingent conditions that require additional
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I action after delivery to the power plant site. A contingent condition is any condition prohibiting the actual use of j material or equipment on-site for its specified purpose. Such j 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. 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.
III. 8 IDENTIFICATION AND CONTR01. 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 o' items (including consumables), is the responsibility of the organization responsible for the item.
Identification of items is traceable to documents such as L design documents, procurement documents, mill test reports or inspection records. Identification of items is verified and ;
i documented prior to release of the item for further use.
'III.9 CONTROL OF PROCESSES l'
1 1 Special processes include those inspection or manufacturing 1
activities that satisfy the following:
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1 o The results of which are highly dependent on the control of i the process and/or skill of the ope'ator; and o The quality of the activity can neither be determined by I inspection, nor it is considered advantageous to perform ;
destructive examinations or tests. t 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 sheet travelers and special processing procedures which are genere**d in accordance with QA procedures. These documents addres, ms 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 NQS. Equipment and personnel associated with special processes ,
are qualified in accordance with applicable codes, standards, l QA procedures and/or centract reqtsirements. Qualification l records are reviewed by NQS, and are maintained and kept I
current by responsible organizations.
- 111.10 INSPECTION L J Inspections are performed in accordance with instructions procedurts and/or control documents which are reviewed by NQS and approved by the responsible organization. These Revision 5
s 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.
i Inspections are performed by personnt'l other than those who performed or directly supervised the activity being inspected l 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 1 current by the responsible organization. {
Instructions and procedures include, as appropriate, l identification of characteristics and activities to be inspected, a description of the method of inspection, identification of the individuals or groups responsible for performing the inspection, acceptance and/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. ,
111.11 TEST CONTROL Acceptance testing (such as hydrostatic, pre-operational, 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. Test 1
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i procedures are submitted for review and approval prior to f testing and the testing is witnessed by assigned and qualified I personnel. Test procedures contain the following, as l applicable:
o Provisions for assuring that prerequisites for the test have been met; o Required instrumentation and accuracies; i o Instructions for conducting the test and for acquiring and f 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 i 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; f o Method of recording test results L o Verification that the test procedures have been reviewed and
- approved.
i L Test procedures and/or controlling documents are approved by
- l NQS.
t Test results, as a minimum, identify the item tested, date of the test, the procedure and revision level, the tester or data t recorder, identification number of the equipment, test conditions, time, type of observation, results and acceptability, individua'i evaluating test results, and noted nonconformances. The test results are evaluated and documented as specified in the test procedure.
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J 111.12 CONTROL OF MEASURING AND TEST EQUIPMENT )
- i Gages, instruments, and other inspection, measuring and testing I equipment and devices used in activities affecting quality are '
required to be of the proper range, type and accuracy in order to verify conformance to established requirements. Procedures contain the detailed requirements for the calibration ,
(technique and frequency) and control, and describe organizational responsibilities for establishing, implementing, and assuring effectiveness of the calibration program.
. 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 postible and practical, !
measuring and test equipment are calibr'ated against standards that have an accuracy of at least four' times the required s
accuracy of the equipment being calibrated. Greater uncertainty may be acceptable when limited by
" state-of-the-art". Where national standards do not exist for reference standards, the basis of the calibration is documented.
The method and interval of calibration for each item is 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.
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L When an instrument is found to be out of calibration, an .i I
investigation to determine the validity of previous inspections f
performed with the instrument and the acceptability of items inspected or tested since the last calibration is conducted, c Inspections or tests are repeated on affected items as' j necessary. ,
c l NQS audits organizational units responsible for control of
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measuring and test equipment to assure compliance with applicable procedures.
III.13 HANDLING. STORAGE AND SHIPPING Procedures are used to control handling, storage and shipping of items to ensure the maintenance of quality from source '
through delivery to the customer. These procedures may be in various formsts 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, loss, or deterioration by environmental conditions. These activities are accomplished by trained personnel.
The application of quality considerations to handling, storage, p and shipping is based upon considerations such as the level of sensitivity of the item to environmental conditions, its resistance to physical forces, and its relative replaceability.
When required for particular items, special equipment (such as ,
l containers, shock absorbers, accelerometers and special tools or handling devices) and special protective environments (such as inert gas atmosphere, specific moisture content levels, and temperature levels) are specified, provided, and verified when l required. These special tools or handling devices are inspected, tested, and controlled in accordance with l
procedures. Only experienced or trained personnel are used to work with these devices.
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Handling, storage, and shipping procedures and/or controlling documents are approved by NQS. Equipment and personnel qualification records are audited by NQS.
!!!.14 INSPECTION. TEST AND OPERATING STATUS
- Documents, such as travelers, process sheets, and work orders L 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. No sequence change is allowed'if it compromises the safety function of the item. Any change to travelers, etc are subject to the same controls as the original. These documents accompany items throughott processing.
Status indicators such as tags, forms, labels, etc. may also be used to identify status of items. These indicators indicate
.th6 current status such as: a)' acceptability or approval of !
the item, b) a hold situation where a nonconformance exists, I and c) rejection where an item is unacceptable for the use ;
i that it was intended. When such indicators are used, only NQS l 1s authorized to affix and remove inspection status indicators.
This assures control of any possible inadvertent bypassing of
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I required inspections, tests, and operations. NQS may waive certain check points, etc. at its discretion.
L III.15 CONTROL OF NONCONFORMING ITEMS L c A nonconforming item is defined as that which does not meet specified requirements.
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Procedures are used to contiol the identification, documentation, segregation (when practical), review and {
disposition of nonconforming items (including computer codes), )
and include notification to affected organizations if !
C disposition is other than scrap. These procedures identify j individuals or groups, including NQS, authorized to disposition :
and approve nonconformances, verification requirements, and describe the segregation and/or control of nonconforming items to prevent inadvertent use. Nonconformances are resolved prior '
to shipment of an item.
Documentation contains the identification of the nonconforming ,
items, a description of the nonconformance and its disposition :
including re-inspection requirements, and documented approval i 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 I and test requirements or acceptable alternatives.
Individuals dispositioning nonconformances are selected based on experience and competence related to the item being i evaluated, and an understanding of the requirements. These individuals have access to necessary background information.
Nonconformances are periodically evaluated by NQS for quality trends. Findings considered significant are reported to management for review and assessment.
III.16 CORRECTIVE ACTION Conditions adverse to quality, such is a nonconforn;ances, 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, customer audits, agency audits / inspections or by independent investigations conducted by NQS.
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QA procedures specify how conditions adverse to quality are documented and reported to cognizant parties, including i appropriate levels of management, for action and for assuring [
that corrective action is suitably identified, accepted and implemented in a timely manner. [
These procedures re.luire identification of cause-(as deemed necessary), corrective action to prevent recurrence, 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 action. NQS 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.
III.17 QUAL.ITY ASSURANCE RECORDS ,
Quality Assurance records are preplanned, generated, stored, and maintained so as to provide objective evidence that quality assurance requirements have been met. The records i program is planned for a standard system but may be expanded 1
or specifically modified in accordance with individual f contract requirements. The system includes provisions for i
records such as: design, manufacturing, procurement, L installation, inspection, and qualification.
I; NQS is responsible for the maintenance of quality record files. Files are indexed to facilitate storage and retrieval.
L The records are reviewed for completeness, per procedure
- l requirements, prior to retention and are available for review by customers, for those records applicable to that customer's l- contract (s).
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Unless otherwise authorized, suppliers are required to submit a t
f copy of designated quality records to NPB for transmittal to the customer (s) before the procurement order is concluded. Prior to shipment of a purchased item, the quality records compiled by the I supplier are reviewed for completeness and acceptability. 'The ,
results of these reviews are recorded. Test results are reviewed and evaluated for adequacy, as necessary, during surveillance visits to supplier's facilities. :
P III.18- AUDITS Internal compliance audits are performed by NQS on applicable NPB organization units at least once per calendar year. External ,
audits of suppliers are performed by NQS at a frequency commensurate with the suppliers scope of supply and status and importance of the suppliers' activity. ,
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 QA 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, de,ficiencies and nonconformances, and verification of corrective action. The audit schedule may be revised if necessary.
NQS personnel assigned to perform audits are qualified and certified prior to their performing audits. All audits performed by NQS are led by a lead auditor. Qualification is based on I training, education, experience, and successful completion of examination. Auditors have no direct responsibility in the areas l
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i audited. NQS may employ qualified auditors from other i organizations to perform audits and/or NQS may use the results of supplier audits performed by other organizations. However, NQS retains responsibility for the audits in such cases.
I An audit plan identifies the area to be audited, audit scope, !
requirements, audit personnel, organizations to b'e notified, )
applicable documents, schedule, and procedures or checklists to l be used. The organization (s) responsible for the activity or area being audited is notified in advance of scheduled audits. 1 An audit report is issued and signed by the Lead Auditor and
. includes the following information, as appropriate:
o description of the audit scope, o identification of the auditor (s),
o identification of persons contacted during the audit, o summary of audit results, including a statement on the effectiveness of the quality assurance program elements which were audited, o description of each reported adverse audit finding in sufficient detail to enable corrective action to be taken by :
the audited organization.
The audit report is transmitted to the audited organization (s)' -
cognizant management.
( If deficiencies are found during the audit the following i
actions are performed:
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o The auditor (s) documents the deficiencies in the audit L
report with a required response date.
L l o The audited organization documents corrective action and returns the response to the auditor within the required l-
! . response time.
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, l 14 o Auditors' assure that deficiencies are answered in the k' allotted time and that adequate corrective action has been implemented or scheduled; verify the adequacy and I completeness _of corrective action; c',o8e out the deficiency when the reported condition has been resol'.ed; and assure that relevant audit documents are retained as records including the plan, 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, Nuclear Quality Systems or President, Nuclear Power Businesses.
Follow-up action is taken until corrective action is completed.
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Nuclear Quality Systems President. Nuclear Power Businesses Vice President. Nuclear Ouality Systems t
Director. Quality Operations Manaaer Quality Proarams Manaaer. Trainina and Administration I Manaaer Quality Assurance (NFM. Windsor) *
! Manaaer. Quality Assurance (NFM. Hematite)
! Manager. Quality Assurance (Newinaton) -
! Manager. Quality Assurance (E-M/C-E Controls) 4 l'
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Figure 11-1 ;
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i Nuclear Power Businesses President. Nuclear Power Businesses Vice President. Nuclesr Quality Systems Vice President. Nuclear SystemsII)
Vice President. Nuclear Fuel (2)
Vice President. Nuclear Services Controller ,
(1) includes C-E Controls / Electro-Mechanics and C-E Newington facilities.
(2) includes Nuclear Fuels Manufacturing facilities.
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Figure II-2 L
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t Table !!I-1 Responsibilities of Nuclear Quality Systems -
s Interface with all NPB organizations in the solution of day to day quality problems, a
Provide for NPB 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 '
NPB QA program. -
Conduct the QA internal audit program.
Provide interpretations for QA Standards.
1 Perform quality data collection and trend analysis.
Maintain NQS personnel training and qualification records.
1 Perform supplier evaluations.
Perform systems audits at supplier facilities.
L Review resolution of deviations / nonconforming conditions.
l Review procurement orders.
1 Establish and execute witness and hold points (surveillance and/or ,
inspection). ;
i Monitor conformance to procurement requirements. 1 i
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Table !!!-7. f L
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Responsibilities of Nuclear Power Businesses Units l
Nuclear Systems:
- 1. Design, procurement and fabrication of Nuclear Steam Supply System (NSSS) '
components, systems and structures for NSSS contracts.
- 2. NSSS Licensing j
- 3. Design and fabrication of instrumentation and control systems.
I 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, syetems and structures to operating nuclear power plants.
Nuclear Fuel:
F
- 1. Design, procurement and fabrication of nuclear fuel (both initial and reload cores) and related products and services.
Controller:
- 1. ' Administrative management duties, such as accounting. (
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.i - Clarifications to NQA-1 and/o- Regulatory Guide 1.28 (Rev. 03)
, Section Clarification Regulatory Guide 1.28 paragrapn C.1 Training procedures are used to ensure that individuals are qualified in a manner commensurate with the-requirements of their job description, operating procedures ensure that activities are accomplished at the correct inspection / organization level; this may be used in lieu of personnel level ratings.
Regulktory Guide 1.28 The frequency of auditing a Paragraph C.3.2.1 supplier is based on:
t) 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 Recora validation / authentication Paragraph 2.3 is controlled by procedure.
P paragraph 4.0 Applies only to records ,
transferred to permanent storage (all other records are classified as " working" files).
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I I Table III-4 .
Typical List of Quality Assurance Procedures o Preparation and Control of Quality Plans '
o Stop Work Order o Indoctrination & Training of Personnel '
o Certification Program for Inspection, Examination and Testing Personnel ;
o Certification Program for Audit Personnel ;
o Certification Program for Nondestructive ,
Examination Personnel o Qualification of Registered Professional Engineers for ASME Code Certifying Activities o Establishment of Equipment Safety & Quality Classifications o Design Input o Design Analysis o Design Interface Control o Design Verification o Preparation, Control & Retention of Drawings o Design Specifications o Design Change, Field Change, Corrective Action o Safety Analysis Reports (SAR) and SAR Changes
- Design Reports o Control of Supplier Technical Change Requests l
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Table !!!-4 (continued) o Preparation, Review & Approval of Purchase Orders ;
o Dedication of Commercial Grade Items o Preparation & Control of Quality Assurance Procedures i o Preparation & Control of Operating Procedures o Preparation & Control of Technical Operating Procedures o Preparation & Control of QA Specifications o- Control of Quality Assurance Manuals o Preparation & Control of Contract Operating Procedures o Preparation & Control of Welding Procedure Specifications o Supplier Evaluation & Selection Approved Suppliers List o Control of Supplier Document Submittals :
o Control of Supplier Nonconformances o Source Surveillance o . Certification of Satisfactory Completion of Work o Inspection o Control of Measuring & Test Equipment o Control of Nonconforming Items o Corrective Action Report o Quality Trend Analysis o Records Retention o Owner's Records Package (Purchased Items) o Control of N Symbol Stamping ,
o Internal QA Audit o Supplier Audits Revision 5
m- ,
Enclosure IV
. (47 Pages)
Buswssses ~
NUCUWt POWER SUOMf5 CENPD -2/s L ,
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3 QUALITY :
ASSURANCE -
a e
PROGRAM ;
A Description of the a
Nuclear Power Spbs Gus.wess,g Quality Assurance Program SOMBUSTION ENGINEERING J
EVISIGl N I - [-hij 0$o e.r l4$1 l i
,p +0b"4 i yG f i i
ABSTRACT
$WD/!!ZZd.$ )
Thisl repert describes the cuality assuranca program employed b the Nuclear Power l,:tr: Division of Combustion Engineering, Inc., " :- ?._'- - for the supply of items and services subject to the requirements of 10CFR5 Appendix B. TheprogramisbasedonandfesponsivetotherequirementsofAN1/ASME gh NQA-1, " Quality Assurance Program Requirements for Nuclear Facilities ; the
% m ASME Boiler and Pressure Vessel Code Section !!!, Nuclear Power Plant ComponencQandtheguidanceinRegulatoryGuide1.28."QualityAssurance Program Requirements (Design and Construction)" (Rev. 03). -
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, Table of Contents {
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Title Pace No. f Cover Sheat i Abstract 11 l l
Table of Contents tii
-1. Introduction- ,
1
-[
}L n m e n II. Nuclear Power M' Quality Policy 2 ,
' !!!. Quality Assurance Criteria 4
!!!.1 Organization 4 III.2 Quality Assurance Program 6 - 1 III.3. Design Control 8 ;
111.4 Procurement Document Control 16:
111.5 Instructions Procedures and prawings 18 III.6 Document Control 19 1
!!!.7 Control of Purchased Items and Servi:es 20 111.8 Identification and Control of Items 23 111.9- Control of Processes 23
!!I.10 Inspection 24 III.11 Test Control 25 111.12 Control of Measuring and Test Equipment 4 77
!!!.13 Handling, Storage and Shipping 28
!!!.14 Inspection, Test and Operating Status 29
!!!.15 Control of Nonconforming Items 29 III.16 Corrective Action 30
!!!.17 Quality Assurance Records 31
!!!.18 Audits 32
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i l' - Taele of Contents (Continued) e
-i Ficures Floure No. Title Pace No.
!!-1 Organization Chart-Nuclear Quality Systems 35 ,
&W4tde2194
!!-2 Organization Chart-Nuclear Power 4peam m 36 ;
i I.AI.111 l Table No. Title Pace No.
!!!-1 Responsibilities of Nuclear Quality Systems 37
@W.f/4dneC
!!!-2 Responsibilities of Nuclear Power O:: r r 38 Business Units .
0/491ftc#rtM S
!!!-3 h to NQA-1 and/or 39 Regulatory Guide 1.28 (Rev. 03) f4 yptCDh li$ Ch hA fo
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- 1. INTR 000CTQN,-
t.1 Purpose Suh et e s t t*'S This report descri es the quality assurance program employed by '
the Nuclear Power,;;:"-- Division of Comeustion Engineering, Inc., ";_;r 0,n-.. for the supply of items and services. '
subject to the requirements of 10CFR50, Appendix B.
1.2 1122' '
ISvDotdat ej This report ir ludes a des iption of controls employed at the !
NuclearPowerlj:f : (NP facilities noted below. Section !!
presents the'NPK comitment to cuality and describes the NPJJ 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 NP facilities unless otherwise indicated. ~
$ (
The NP/ facilities and the activities involved at each facility include:
i t
Facility Activities 9
NP[Headauarters, Engineering services and NSSS ,
Windsor, CT (with design, procurement, testing, offices also in inspection, repair, installation, Chattanooga, TN) and spare parts Nuclear Fuels Manufacture of nuclear fuel Manufacturing, pellt,ts, fuel assemblies and Windsor, CT. and control element assemblies and I Hematite, M0 associated activities l
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_ _ _ . _ _ _ _ _ _ _ _ _ _ _____ _ _ ._ ____ u
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C-E Cont ols/ Electro- Design and manufacture of Mechanics, New instrumentation & control Britain, CT and systems and associated activities i
Windsor, CT C-E Newington, Design and manufacture of Newington, NH mechanical systems and 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. I
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&p ' ^o l !!, NUCLEAR 90WER -G46ftMS OUALITY 90LICY l; i II.1 Policy Statement j
3pJostette*2 j The 6 President, Kuclear Power 4yeh ms, has l l- authorized the following statement concerning quality l assurance policy: .
t.
i l "A primary objective of Nuclear Power is to deliver to l our customers defect free, competitive products and services l on time that fully comply with contract requirements.
t l The Vice-President, Nuclear Quality Systems has the responsibility for defining the NP quality assurance program l
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. . - - ..~.. - - . _ - . - . . - - - . - - - - . . . - -
and shall bri to the attention of the M ' :: President, Nuclear Power ones.rd.t*
any qua lity problem that cannot be !
resolved within the normal execution of this responsibility".
!!.2 -Quality Assurance Orcanization S
TheQualityAssurance(QA)organizationinNPgisshewnin Figure !!-1. 7 1
The Vice President, Nuclear Quality Systems (NQS) is responsible to assure that the QA policy, goals and objectives ;
are transmitted through levels of management and im,,osed on i quality functions. This is accomplished by distribution of f Quality Assurance Manuals which contain QA policy statements.
. . Responsibility for nuclear quality assur nce rests with the Emee d&medues President, Nucleer Power a'nYis delegated to the Vice President, Nuclear Quality Systems, who !
.[ lmay further delegate specific activities to NQS personnel. -
06 h Such delegation includes authority to stop work for i d,g noncompn ance to requirements.
Sto, p ordgr Ne)xecuted may .y .
originated at any organization levelA atthelevelofaManager, Director,emVicePresidenth action. In all cases where personnel perform quality assurance functions, this delegation provides them authority l
and freedom to initiate, recommend, or provide solutions to i quality problems through management channels.
Compliance with quality requirements is measured through i planned surveillance and/or audit activities and corrsctive I action follow-up by NQS personn 1. NQS is independent of
( otherorganizationswithinNP/asshowninFigureII-2. NQS interprets quality related industry standards for intent and guidance and is responsible for assuring that all quality assurance related procedures used in NP comply with
- j. established QA requirements. 7 l
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& J 111. QUALITY ASSURANCE CRITERIA This section describes each of the eighteen (18) elements o the Combustion Engineering, Inc., " u.. ;,........ Nuclear Power N l Division quality assurance program, f
!!!. 1 Organization Combustion Engineering, Inc., (C-E) has corporate headquarters
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at Stamford, Connecticut, and is a diversified energy syster.;s and services company, t contains several divisions, one of wJondMeR!*
which is Nucl r Power T Eweeweve44ee President, &
unnd.so Nuclear Power Division (N is responsible for'the supply of nuclear systems, nuclear fuel .j QAresponsibilitiesoriginapwithinNP)gdnuclearservices. as illustrated in Figures !!-1 and !!-2. NP[lsheadquarteredat1000 Prospect Hill Road, Windsor, Connecticut 06095.
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S EachprojectundercontractatNPJiscoordinatedbya ~
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 documenting all project work, assuring conformance with contract requirements and maintaining communicationchannelsamongNPT,thecustomer,andallother participating organizations. 6 l
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s TheVicePresident,NuclearQualitySysteg(NQS)reportsat the same organizational level as other NPA Vice Presidents. f i Responsibilities of NQS are listed in Table !!!-1. These responsibilities are carried out through the NQS staff (Fi ure ,
!!-1) and by coordination of all QA activities within NPg.
Details on responsibilities and interfaces among NQS and other l
organizations are contained in QA manuals and procedures.
These interface relationships address items such as auditing, l investigation of quality problems, and implementation of corrective action. Responsibilities of the other NPS units are listed in Table 111-2.
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NQS functio s as an independent communication channel between -
7 senior NPk nanagement and line management. This assures that l
senior NPI nanagement is appraised of quality matters and that the NQS staff receive and comply with dir et vg g the ,
Lh2'....'... President,NuclearPower via the Vice
- President, Nuclear Quality Systems. -
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r The Vice President, Nuclear 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 ,
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supplemented by reports from the NQS management staff to the i Vice President, NQS and from the Vice President, Nuclear I Quality Systems to the 4meem e o-44ee. President, Nuclear Power
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The detailed organizational structure of NQS as well as the number of personnel in NQS may change over time depending on 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 matters. I i
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! NQSpersonnelselectionisbasedonknowleageofNPR l operations; QA regulations, practices anc stancards; past j working experience in CA or related activities in nuclear !
power or a similar high technology industry and education cDesiderations. In addition, NQ$ management assignments are !
also based on evaluated manag ment experience in similarly l L' ' '
responsible positions. !
!!!.2 Cuality assurance Proeram I
!!!.2.1 Sunnary Desc*intion !
6 l TheCAprogramdescribedhereinisemployedbyNPfforthe l supply of % ems and services subject to the requirements j of 10rTd50 Appendix 8. The program is based on and i responsive to the recuirements of ANS!/ASME NQA 1 " Qual ;
Assurance Progree Requirements for Nuclear Facilities j the ASME Code, and the guidance in Regulatory Guide 1.2 , *
" Quality Assurance Program Requirements ',0esign and i Construction)" , h $ Alternatives to the explicit f requirements and guidance given in NQA 1 and/or Regulatory {
Guide 1.28 are described in Table !!t*S. I
!!1.2.2 proaram Control ,
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e Thjequirementsofthisprogramareimplementedateach NP rfaciltty through CA manuals and procedures applicable !
to the activities conducted at each facility. All such 'I documents are reviewed, approved and controlled by NQS to assure compliance with program requiremerts.
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!!!.2.3 Evaluation of program Effectiveness j f
The scope, status, implementation and adecuacy of the QA f
program are assessed by senior levels of managemen several (
ways. The 4sioeweswomW6ee President, Nuclear Power
- N#- i receives a monthly report from the vice President, Nuclear f Quality Systwt covering major cuality issues such as:
l significant internal and customer audit findings, industry (
ouality related developments, and quality improvement needs.
l Quality issues and assessments are discussed during regular i nr.sff etings with sne vice Presidents invoived. The vie. !
President, Nuclear Quality Systems is assess 9d, at least f
annually, for the performance of the QA e g g the ;
4meest4wv$w President, Nuclear Power through a j documented management appraisal system. ,
!!!.2.4 Personnel Indoctrination and Trainine
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i The responsibility fo* assuring that personnel performing j activities affecting ouality are suitably trained rests with l the organization performing those activitiesj Detailed l personneltrainingrequirementsforeachNPffacilityare !
contained in QA procedures. NQS is responsible for assuring f that training requirements are met. [
l Inctoctrination, training and Qualification of personnel performing engineering, purchasing, fabricating, installing, L handling, shipping and storing activities consists of at least: f F
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- ' o indoctrination in the purpose, scope and implementation !
, of QA manuals, and applicable instructions and procedures i through self study, }
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o proficiency tests and/or performance reviews, and/or i t
on the job observations as determ.ined by manegement, to i determine adequacy of training and qualification, l o maintenance of proficiency by performance review, and/or reexamination, and/or retraining as determined by f management, Indoctrination, training and qualification of NQS personnel l
verifying quality - affecting tctivities consists of the three i items above and in addition the following: i l
o training and qualification in the principles, techniques !
and requirements of the activity being performed. l Documentation for these formal 3rograms normally include .
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the program objective, content, attendees, date(s) of the }
training or certification, and appropriate approvals. ,
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.k' r For all of the abo e, raining and qualificationAh !
d g,P JY1 and/or proceduresgae ineate the specific functions personnel f are qualified to perform as well as the basis for the ;
cualification. l
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!!!,3 DESIGN CONTROL !
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!!!.3.1 General j Quality assurance procedures are used to assure that der,ign i activities are carried out in a planned, controlled and timely i manner and that applicable design recuirements are established and correctly translated into design documents such as f calculations, specifications and drawings.
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These procedures provide specific instructions for accomplishment of design activities by defining recut **ments for design inputs and j outputs including: l o document format and content, f o document identification, f o review and approval, f o design vertftcation. l o issuance and distribution, l c revision control, o indication of document status, f
o reco,d ,etention.
The procedures @_ f P h':f to design / engineering activities es=l!
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stress, thermal, hydraulic and accident analyses; compatibility of f materials; accessibility for intervice inspection, maintenance and i repair; fuel design; instrumentation and controls design; and delineation of acceptance criteria for inspections and tests. . l 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; f
o materials, parts, equipment, and prcresses (including l comercially obtained items) essential to the [
safety-related functions of basic components are reviewed >
for suitability of application and comp 6tibility with !
overall system design criteria; o design interfaces among participating organizations ;
internal and external to NPS are identified and ;
controlled; i o design work is verified or checked for adecuacy; o design changes, including field i.nanges, are subject to the same degree of control as applied to the original work. :
[g f,yg h d ds/ fit f6 M b N f y f0C 9slu rd*j R 1 is moirr/ored b y N 0 5 " ^'r"evision e/ $ l co nrp/inwce. Hon-
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!!!.3.2 Desien Inouts [
Design work begins with the definition of the design i recuirements or design bases information. These requirements ;
corpe fr m several sources internal and external to NPS. h w-- - I sources include.& .. _ _... ' = previcusly approved g designs,e e h-from engineering ane pro.uct devoicoment effortsj ^"-- 1 ::; ::: '- '_t: r;; ic. -
.'.. ^ .- i
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j contracts (h equipment performance criteria, design v , life, regulatary requirements, codes and standares, interface j outrements, etc and information from industry or
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L g ) government funded research activities.
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1y i f A Project / Task Manager (or equivalent) suonlies the Cogni: ant Organization (s) (CO) with the design requirements or design i
bases ano applicable cuality requirements that are specified f
in contract documents, bid specifications, regulations and !
industry standards as applicable to the respective efforts. i Within the CO, specific tasks are established and assigned to- f cognizant engineers. The CD is responsible for selection and
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documentation of design inputs including the identification, !
substantiation, and documentation of changes from 3,reviously I approved cesigns. l l
The CO assures that design inputs have been verified or (
annotated to clearly indicate data or assumptions that must te !
I l confirmed by later design efforts or tests anc that the design j I
inputs are traceable by reference to the source of the data. I Design documents containing input data are approved by the author and verifier (s) of the documents. ;
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!!!.3.3 Desian Calculations !
B The C0 is respunsible for selection of input data and analysis !
method, justification of assumotions, and preparation of design calculations. {
I Documentation of design calculations is detailed in purpose, i 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. !
An v LL) h h g Comput., codes (us.dind.signan.lys..har.v unico.iy ;
Q id.ntifiedg g . w r t.st.d and verified to assur. l 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 inputa and outputs. Evidence of testing and.
l verification of a given version of a computer code is documented and incluces the signature of tne author and !
verifier (s) of the coce testing documentation. Dissemination !
af information on computer code errors is provided via a ;
computer program error notification system. Computer source !
codes are protected by security methods to preclude
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unintentional, unplanned or unauthorized modifications.
A cualified individual or group is assigned to verify the f design work (see !!!.3.7, Oesign Verification). When 4 !
I standardized or previously proven design is used, the verification process is not duplicatea, however, the !
applicability of the standardized design is checked with respect to meeting pertinent inputs. ,
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The cover sneet or revision page of the document includes l
provisions for unique identification and the signatures of the f authnr(s) and verifier (s). l
!!!.3.4 Desian Specifications The CD is responsible for the preparation of design I i
specifications. These specifications contain a complete basis j for construction of items in accordance with the requirements i of the ASME Code, contractual documents, regulations, and f
other applicable information, and in conjunction with design ;
drawings, contain all necessary information regarding ,
materials and design. A design specification includes.
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o functions and boundaries of the items covered.
- o the design requirements including all required
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overpressure protection requirements, !
o the environmental conditions including radiation, !
o the safety classification of the items covered, - !
o material requirements including impact test requirements.
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o operability requirements as appropriate, !
o the effective ASME Code Edition, Addenda and Cases and other i appropriate industry standards to be used for construction,
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o records required to be maintained, ,
o special inspection, testing, and quality assurance 4
requirements.
A qualified individual or group is assigned to verify the .
t specification (see !!!.3.7. Design Verificatior.). The cover '
sheet or revision page of the document includes provisions for ,
unicue identification and approvals of the author and verifier (s). ;
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!!!.3.5 Desian Drawines ),
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1 The CD is responsible for the preparation of design drawings.
l These drawings include functional requirements for j system / component interfeces, arrangement and layout, which are j not directly used for producing an item. Examples include:
l 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 drawing, the technical requirements tc be incorporated and any {
special features or notes to be included. The ) reviews the i design drawing for technical content and agreement with !
calculations, analyses, or other applicable design !
specification requirements. Additionally, a qualified I individual or group is assigned to verify the contents of the ;
drawing (see !!!.3.7, Design Verification).
!!!.3.6 Other Desian Documents !
The C0 is responsible for preparation of other design documents j needed to define or describe engineering requirements. These j documents typically include items such as: design bases or j design data information: system descriptions; interface !
recuirements; test requirements; guidelines for startup and operation; guidelines for installation; engineering studies; and software verification plans and results. A cualified
/
I individual or group is assigned to verify the design document l
(see !!!.3.7, Design Verificat' ion). The cover sheet or ,
revision page of the document includes provisions for unious f identification and approvals by the author and verifier (s). l
!!!.3.7 Desian verification Design output is reviewed to verify its adequacy. This ;
verification provides assurance that the oM put meets the specified inputs and is correct and complete. i
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Yhd 3 Verification activities are performed by an individg 1 or group
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other than those who performed the original work %e v verification may be performed by the originator's supervisor provided the supervisor is the only individual in the C0 competent to perform the verification er provided; o the supervisor did not specify the design approach jM M w did not rule out certain design k consiceratior.s. W s n the supervisor did not establish the design input.
) N '
M,fs hf $ The CD determines the particular design verification method (s)
N to be useo and designates the individual or group responsible for the verification efforts. The acceptable verification
[ g g W ' d methods include design reviews, alternate calculations, and per# qualification testing and are defined as follows:
AJ fr J[*1d ,
o oesi,n nev4e.,s in.e.en.ent revi - to assure that the Ae, 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 more),
prototype or initial procuction unit.
Qualification testing (as apposed to acceptance testing) is performed to test requirements established by the C0. The testirg recuirements include test conditions that simulate the mcst adverse design cone.itions (operating modes and environment) for the specific design feature (s) being verified. Test results are documented by the testing organization and evaluated by the C0 to assure that test 1
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reouirements have 6.en met, when tests are being performed on !
Q, /[ models or mockups, scaling laws are established and verified f and results are subject to error analysis when soplicable prior to use in final design work, l j
esults of the verification are documented identification of the verifier (s). Design verification is j completed prior to relying upon the component, system, part or structure to perform its safety related function.
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!!!.3.8 R,evision Control j I
Design document revisions are subject to the same review, ;
approval and distribution controls as these appliert to the [,
original work. Revision level notation is used to assure that !
obsolete or superseded documents are not used inadvertently. !
Quality atsurance procedures include requirements for !
evaluation of repcrted changes resulting from items such as: ,
o cualification, 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 f o operational experience.
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Where changes to previously verified work have been made. I verification is repeated by the organization currently I responsible for the work or by an equally cutilified l organization having access to the pertinent information.
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!!!.3.9 Interface Control
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i Quality assurance procedures contain the organizational l
structure within which the program is implemented and delineate t the authority and responsibility of the C0's involved. The l organizational interfaces among contributing C0's, both !
internal and external to NP are controlled in accordance with these procedures. ;
Three procedures control the flow of design information by requiring the formal release of outputs involving interface l
information to other functional groups. This is accomplished within NPS by documented correspondent or standard document distribtuton forms and external to NP y letters or approved procurement documents. The transmittal identifias the l verification status of the information or document and, where {
necessary, identifies incomplete items which require further i verification. Where it is necessary to transmit design !
information orally or by other informal means, follow-up by a - l controlled document is provided. Interface comunications are trMeable frts a request through a related response to assure
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l completeness and accuracy.
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!!!.4 PROCUREMENT DOCUMENT CONTROL ?
i Controlled procedures are used for the preparation, review and
, I approval of procurement documents. Groups that prepare, review and approve procurement Jocuments are identified in the . '
proc.dures. 7 4 a 5M @
d?, 2o W y0p&. =271) p - # .
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/ es.
krocuremen,tdocumentsinclude(eitherdirectlyorbyreference) l; the following requirements, as applicable: !
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I o regulatory, ASME Code and industry standards; ,
i o tests and inspections, including acceptance criteria; i o quality assurance program elements; l
c Quality assurance records retention times and disposition; >
o reporting, approving and dispositioning nonconformances; !
o rights of access by NpS and/or its representative (s),
o documentation submittal, review and approval; i o extension of requirements to sub-suppliers; l o technical / design (including drawings and specifications); !
o administrative; and ,
o special processing. I B ;
ItistheresponsibilityoftheNP(organizationthatprepares f 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 j chEnge the roouirements of the ofiginal procurement. .
The procurement process for commercial-grade III items and i services uses the same review and approval cycle. These are i bought to commercial standards where standards are available, i Commercial items that become part of a system may be tested as ,
part of the completed syrtem. Procurement documents for ;
standard commercial or previously approved items including spare or replacement parts essential to the safety functions of structures, systems, and components, are reviewed and approved by personnel trained in QA procedures. l (1) Controls limited to those items and services to be subsequently ded'.catedbyNPfas"basiccomponents".
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!!!.$ !NSTRUCTION
S. PROCEDURE
S AND ORAWINGS j Quality affecting activities such as engineering, manufacturing, inspe: tion, testing, certification, handling, I storage, shipping, etc., are prescribed by and performed in accordance with cocumented instructions, proc 3dures, or drawirgs of a type appropriate to the circumstances. Quality I assurance procedures require that these documents include or reference Quantitative or qualitative acceptance criteria for ;
determining that the activity has been satisfactorily accomplished.
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The following is a sunmary of the types of instructions, i procedures, and drawings used to control cuality affecting l activities, i i
OA Manuals, procedures and Instructions - documents containing i the systems and procedures that ipecify and describe the l activisi.sperformedwithinsafoprovid.ad..uas.confid.ne !
that art item 0,rserviceprovidedmeetsapplicablerequiremeyn.N .
c W .d ,to f f Q k & " h 4N f&f($M I procurement Occuments - documents taat specify requirements for f b purchase of an item or service including purchase requisitions, g q '
drawings, process or material specifications, procedures or instructions.
l process Control Documents - documents that are used to control ;
operations on items. These operations include: forming, machining, assembling, welding, brazing, heat treatment, examination, taspection, testing, plating, etc.. These .
documents include: ;
o process $heets/ Travelers /Werk Orders - contain steps and the '
sequencing of operations performed to produce or install an item.
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o Manufacturing Crawings - contain or reference item form and fit recuirements, 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 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.
!!!.6 , DOCUMENT 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 cuality requirements or th,at prescribe activities affecting quality. The procedures specify how documents are reviewed for adecuacy, 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 Reperts, nonconformance reports, as-built documents, and those documents identified in Section !!!. 5; l
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o use of distribution lists cr equivalent to assure that the !
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L proper personnel or organizations are provided the required !
documents to perform the work; I
o document identification to assure that the proper document ]
is used in performing a particular activity. The i identification includes the document number or any other relevant information that identify the document to be used; ,
i 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 !
t organizations are specifically designated. In all cases, the - .
reviewing organization (s) has access to pertinent information I or background data upon which to base approval. i
!!!.7 CONTROL 0F "URCHASED ITEMS AND SERVICES Items and services are procured from approved suppliers. QA l procedures specify reautrements for supplier evaluation and I selection, control of supplier generated docur.ents, acceptance l
of the item or service (by documentation review, source ;
surveillance, source and/or receiving inspection), control of !
nonconforming conditions, supplier performance evaluations l (assessments and audits), and qualification of NPS audit, ,
inspection and surveillance personnel, i
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men is.eified in procurement docum.nts, og p.rterms j surveillance of suppliers during fabrication, inspection, !
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 recuirements of the ptscurement j documents are used as the basis for surveillance. The degree l of surveillance varies with the degree of imtortance of f
equipment supplier performance, and complexity of items. The j
. degree of surveillance is determined by the organization that j prepared the order and by NQS. This surveillance is performed !
using instructions which define the operation or process to be f witnessed and the verifications to be made.
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The procurement of spare or replacements parts and components ;
are governed by customer 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 recuirements
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of the procurement document have been met.
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Initial cupplier approval is via survey or evaluation that is r conducted by NQS. The purpose of these are to verify that the i new supplier is capable of complying with the cuality !
reouirements in the procurement documents. The results are j documented and any identified deficiencies are resolved prior l to starting work.
l Supplier approval is maintained by annual evaluations and [
periodic audits. The annual evaluations take into !
consideration items such as supplier furnished documentation; l results of prior surveillances, inspections, and audits; and
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Suppliers that have received ASME approval are approved on the basis of the ASME approval.
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ForitemsshippedtoaNP[manufacturingorwarehousefacility, receiving and/or source surveillance procedures are used to t assure that the item and specified documentation comply with the procurement document requirements. Measures are !
established to assure that items accepted and r61 eased are f
identified as to their inspection status in order to prevent i the use or installation of non accepted items and provide for I the entry only of accepted items into the warehouse. The status is identified on the item or on documentation traceable l to the item. [
I 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 l identifying the item and the applicable procurement documents, and certifies that the item meets all applicable procurement
- l requirements, including documentation requirements. The j certification includes identification of any NPS approved
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deviations from the procurement requirements and is approved by !
authorized personnel. Procedures identify the actions [
necessary to initiate. authorize, issue, distribute, and revise i certifications, these procedures include provisions for review I and acceptance of supplier furnished cocumentation (e.g. '!
certificatas of conformances, certified material test reports, l non-destructive examination reports) and for identifying and i following up contingent conditions that require additional i action after delivery to the power plant site. A contingent l condition is any condition prohibiting the actual use of l
material or eouipment on site for its s peified purpose. Such !
items may be shipped to the site to permit partial testing or f 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 t1 ensure that they are valid.
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!!!. 8 lDENTIFICATION AND CONTROL OF ITEMS l i
Identification recuirements are controlled by procedures and are specified in the procurement and process contr:1 documents '
for quality related products and services.
l 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 l Quality of the item supplied. Identification and control of i items (including consumables), is the responsibility of the !,
organization responsible for the item. * !
Identification of itens is traceable to documents such as !
t design documents, procurement documents, mill test reports or i inspection records. Identification of items is verified and i documented prior to release of the item for further use, i i
!!!.g CONTROL OF PROCESSES i Special processes include those inspection or manufacturing activities that satisfy the following: I r
o The results of which are highly dependent on the control of l the process and/or skill of the operator; and o The quality of the activity can neither be determined by ,
inspection, nor it is considered advantageous to perform h t
destructive examinations or tests. '
t Revision 5 i t
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I Special processes include activities such as welding, heat !
treating, non-destructive examination, and cleaning.
These type of processes are controlled by douments such as l process sheet travelers and special processing procedures f
which are generated in accordance with QA procedures. These l
, documents address items such as: i l
o process procedure, personnel and equipment qualification requirements i
o process prerequisites l
o acceptance criteria !
o environmental consitions .
s i
Process procedures and/or control documtats are approved by f NQS. Eeuipment and personnel assaciated with special processes f' are cualified in accordance with applicable codes, standards -
QA procedures and/or contract requirements. Qualification records ar. r. view.d by wQs, and are maintain.d and x.pt !
current by responsible organizations. l
!!!.10 INSPECTION f I
Inspections are performed in accordance with instructions !
l procedures and/or centrol documents which are reviewed by NQS
[
and approved by the responsible organization. These j instructions / procedures provide criteria for determining t accuracy recuirements of inspection equipment, how and when j inspections are performed; and, mandatory inspection hold [
I points beyond which work may not proceed until inspected by a i designated inspector, i
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Inspections are perfomed by personnel other than those who l
performed or directly supervised the activity being inspected l
and who do not report directly to the in wediate supervisors who j are responsible for the activity being inspected. The l i
personnel performing inspections are trained, qualified and ;
certified in accordance with procedures. The records of l Qualifications and certifications of inspectors are kept i current by the responsible organization. f i
Instructions and procedures incluce, as appropriate, ;
identification of characteristics and activities to be i inspected, a description of the method of inspection, !
identification of the individuals or groups responsible for i performing the inspection, acceptance and/or rejection I i
criteria, identification of required procedures, drawings and !
specifications including revisions, special inspection i
equipment and accuracy requirements, recording of the results
{
of the inspection, and the inspector or data recorder.
t The orgsnization or individual performing the inspection is [c normally responsible for evaluating the results and determining j the acceptability of the inspected item. j e, i
!!!. 11 TEST CONTROL I l.
Acceptance testing (such as hydrostatic, pre operational, i
etc.), and destructive examination testing (such as, !
metallurgical, etc.) is performed using centrolled procedures.
The test procedures address the requirements as specified in ,
test recuests, specifications and/or codes and standards. Test i procedures are submi ted for review and approval prior to
,g[ testing and testing is witnessed by assigned and ,
qualified personnel. Test procedures contain the following, as applicable: ,
i P
o Provisions for assuring that prerequisites for the test have '
been met; !
, o Required instrumentation and accuracies; i
Revision 5 l
L l
i o Instructions for conducting the test and for acquiring and ;
recording the data necessary for evaluation; l 0 witnessing of the t. sting by ouaiified pe.s nnei. l o Required environmental conditions; f o Acceptance and/or rejection criteria required to evaluate !
the test; f
o Recording the performance of the test; !
o Use and identification of calibrated equipment; f o Code and contract recuirements; j i o Test personnel qualification; (
o Method of recording test results; f' o Verification that the test procedures have been reviewed and approved.
Test proceaures and/or controlling documents are approved by f
NQS.
Test results, as a minimum, identify the item tested, date of t the test, the procedure and revision level, the tester or data' f recorder, identification 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. !
!!!.12 CONTROL. OF MEASURING AND TEST EQUIPMENT ,
f Gages, instruments, and other inspection, measuring and testing l equipment and devices used in activities affecting quality are required to be of the proper range, type and accuracy in order ;
to verify conformance to established requirements. Procedures [
contain the detailed requirements for the calibration
{
(technique and frequency) and control, and describe organizational responsibilities for establishing, implementing, I and assuring effectiveness of the calibration program.
l l
l.
Revision 5 ,
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_ . . _ , _ . . . . - - , . _ , . . ~ . , _ , _ _ . - _ , . ,
. . _ . _ . , _ . . . _ , _ . _ _ . - _ . . . . _ . _ _ _ . . . , __ m____- . _ -- . __ . . - . _ . _ _ _ _ _ _ .
i L
! i l
l f Standards used for calibration have known valid relationships t
j- 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 f
which they are being used. When possible and practical, l measuring and test equipment are calibrated against standards !
.that have an accuracy of at least four times the required t accuracy of the oculpment being calibrated. Greater l uncertainty may be acceptable when limited by f
" state-of-the art". Where national standards do not exist for f
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, reouired 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 i identification also indicates the date of the next required ;
calibration. !
When an instrument is found to be out of calibration, an f 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 l necessary. [
NQS audits organizational units responsible for control of ,
measuring and test equipment to assure compliance with applicable procedures, t
Revision 5
!!!)13 HANDLING. STORAGE AND SHIDDING v i 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, I handling, storage, packaging, shipping and preservation methods to preclude item damage, loss, or deterioration by i
,h environmental conditions. Whesusegu6eed se activities are accomplished by rained personnel.
The application of quality considerations to handling, storage, and shipping is based upon considerations such as the level of {
sensitivity of the item to environmental conditions, its resistance to physical forces, and its relative replaceability.
- When required for particular items, special equipment (such as !
containers, shock absorbers, accelerometers and special tools I or handling devices) and special protective environments (such i as inert gas atmosphere, specific moisture content levels, and temperature 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. l Handling, storage, and shipping procedures and/or controlling ,
documents are approved by NQS. Equipment and personnel qualification records are audited by NQS.
t t
Revision S
!!!.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 l
indicate the status of the operation (s) being performed, the i required signatures (or other similar wans), and the date l indicating when a given operation, test, inspection, or examination was completed. Quality assurance procedures l control the use of travelers, process sheets and work orders l including methods for making sequence changes and [
identificationofnonconformingitems.gThesedocuments l accompany items throughout processing.
i 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 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 j certain check points, etc. at its discretion, j
!!!.15 CONTROL OF NONCONFORMING ITEMS l
A nonconforming item is defined as that which does not meet specified requirements. )
No ,
f .
.e f .
g 7 -- -- r A> c:= d ~ .e./c. " ;
f&f fWeh" l Revision 5 >
g .
f
I. l
. 1 Procedures are used to control the identification, l 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 J g and approve nonconformances, verification requirements, and describe the segregation and/or control l y7 Awe.nt 17g.rt.nt ,e us..mJn:me m .g to prov i dv Ne~gfjf nonconfo l Documentation contains the identification of the nonconforming l
items, a description of the nonconformance and its disposition j 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 origintl inspection i and test requirements or acceptable alternatives. f i
i 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 NQS for Quality trends. Findings considered significant are reported to management for review and assessment.
f
!!!.16 CORRECTIVE ACTION ;
Conditicns adverse to quality, such as a nonconformances. l failures, malfunctions, deficiencies, deviations, or defective !
materials and equipment, are identified, documented and '
reported to appropriate levels of management. These f conditions may be identified by suppliers, surveillance, inspection or. audit activities at suppliers, internal audits / inspections, customer audits, agency audits / inspections !
or by independent investigations conducted by NQS. -
Revision 5 t
- - - - - - 4 r.,. . . . , _ . - _ . . . , . . . , . _ . _ _ _ _ _ _ . . . _ . _ . . _ . _ . . _ _ . _ . , _ . . _ _ . _ , . , . _ _ . . - . _ _ _ _ . . , _ _ _ , - . . , . , , - , , . , . _
t l l t
QA procedures specify how conditions aoverse to Quality are l documented and reported to cognizant parties, including appropriate levels of management, for action and for assuring that corrective action is suitably identified, accepted and i g implemented d A b 8^#M These procedures require identification of cause (as deemed !
necassary), corrective action to prevent recurrence, f verification of implementation; and follow up and close-out of I intt'nal audit, and supplier audit / surveillance audit ;
findings. Follow-upactionistakenbyNQStovertf
,2[ corre se/ gtive
.c, 4action. #@8*Adar'""'"
I 4m r' -
l Trend analyses are periodically performed on surveillance and !
audit activities. Results of such analyses are reported to ,
appropriate levels of management. ,
5
!!!.17 OUALITY ASSURANCE RECORDS Quality Assurance records are proplanned, generated, stored, !
and maintained so as to provide objective evidence that f
Quality assurance requirements have been met. The records i program is planned for a standard system but may be expanded l or specifically modified in accordance with individual f
contract requirements. The system includes provisions for records such as: design, manufacturing, procurement, ,
l installation, inspection, and qualification. l NQS is responsible for the maintenance of Quality record '
files. Files are indexed to facilitate storage and retrieval, i The records are reviewed for completeness, per procedure requirements, prior to retention and are available for review i by customers, for those records applicable to that customer's '
contract (s). t:"*^"*""":'..:.... ....1;.
Q, 30 =.-...: ---
1 1
Revision 5 4
4
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l Unless otherwise authorized, suppliers are required to submit a copy of designated quality records to NPS for transmittal to the l
customer (s) before the procurement order is concluded. Prior to !
shipment cf a purchased item, the quality records compiled by the l supplier are reviewed for completeness and acceptability. The l results of these reviews are recorded. Test results are reviewed i and evaluated for adecuacy, as necessary, during surveillance visits to supplier's facilities,
!!!.18 A,@LT,}, by M N ,
f by W Internal compliance audits are I erformegonapplicableNPg g
organization units at least ont per calender year. External audits of suppliers are performe at a frequency commensurate j with the suppliers scope of supply and status and importance of i the suppliers' activity, i i
An annual audit schedule is established indicating the frecuency" and organization (s) to be audited. The audits include review of f activities affecting Quality. $1nce all elements of the QA 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,
{
j
$( ,
$QSpersonnelassignedtoperformauditsaequalifiedand }
F certified prior to their performing audits. Qualification is j j based on training, education, experience, and successful !
completion of examination. Auditors have no direct +
responsibtitty in the areas audited. N W U .p !
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An audit plan identifies the area to be audited, audit scope, ;
requirements, audit personnel, organizations to be notified.
Y applicable documents, schedule, and procedures ar checklists to !
be used. The organization (s) responsible for the activity or j 3
area being audited is notified in advance of scheduled audits. '
An audit report is issued and signed by the Lead Auditor and :
incl.wis the following information, as appropriate:
o description of the audit scope, s.
o identification of the auditor (s),
1- o identification of persons contacted during the audit, o summary of audit results, including a statement an the effectiveness of the quality assurance program elements which were audited, o description of each reported adverse audit finding in sufficient ietail to enable corrective action to be taken by the audited organization.
The audit report is transmitted to the audited organization (s)'
cognizatit management.
If deficiencies are found during the audit the following
- . actions are performed
o The auditor (s) 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.
L t
l 4
Revision 5
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i l
o Auditors assure that deficiencies are answered in the allotted time and that adequate corrective action has been I implemented 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 audit documents are retained as records ,
including the plan, report and corrective action completion.
}Ah, f "h:: W .
o incomplete e ctive action responses are brought to the ;
attentionoffmanagementforresolutionandifnecessaryto the Vice President, Nuclear Quality Systems Follow-up i
action is taken until corrective action is empleted.
@ bA pW"~ . ; t l I
-i r-Revision 5 4
e b e v , - - , - ~ , , , , , . , , , . , - - , - + - , - - .----,,,,,-,,w.,-, ,,,,w.,, ,-,,,,,,-,,n,-,, - - - - - - - - . , .
I: i ! i
.s t P
Nuclear Quality Systems i
~ M C/ of 45? 9]
President. Nuclear Power M a: : -
.....i., . .
Vice President. Nuclear Quality Sys h - Director. Quality Operations Manaaer. Quality Procrams . Manaaer. Trainina and Administration I Manaaer. Quality Assurance (NFM. Windsor) i Manaaer. Quality Assurance (NFM. Hematite) > a i Mananer. Quality Assurance (Newinaton) l Manaaer. Quality Assurance (E-M/C-E Controls) - l c t E l Figure !!-1 4 35 - Revision 5 l } .' l
(: - > a i !~ , l
\
Nuclear Power E:'WS : : //7ftfef - 1 o R ': "'-- President. Nuclear Power ]Ett: ;utt ett gf 93 i Vice President. Nuclear Quality Systems , Vice President. Nuclear SystemsII} Vice President. Nuclear Fuel ( } Vice President. Nuclear Services t Controller F (1) includes C-E Controls / Electro-Mechanics and C-E Newington facilities. (2) includes Nuclear Fuels Manufacturing facilities. , i F i i Figure 11-2 36 - Revision 5 4 iY I 4 - - , , . - - --w ,-----,,a ,-,we.. ,--,.,e - r,, , - .,-.,,~,n,- , -,,--. ,.w.-,-,.-a,,,e,en- --, ,m 4 w n,r ev , , - - , , , e- - g,,+-m~ < -
7: I Table !!!-1 ; l t i Responsibilities of Nuclear Quality Systems j Interface with all NP organizations in the solution of day to day quality problems. I ProvidsforNP/>thenecessarydirectionforqualitythroughapprovaland i distribution of quality policies, manuals and procedures.
. i Provide an assessment of the scope, status, implementation and adequacy of the l NPS QA program. I Conduct the QA internal audit program.
t Provide interpretations for QA Standards. Pefore quality data collection and trend analysis. , , Maintain NQS personnel training and qualification records. Perform supplier evaluations. ( Perform systems audits at supplier facilities. . 1 Review resolution of deviation ##Pf8 @L_i
" ~ }Cswh L
Review procurement orders. [ Establish and execute witness and hold points (surveillance and/or [: inspection). Menitor conformance to procurement requirements. Revision 5 l
I i Table !!! 2 i l 1 ff Responsibilities of Nuclear Power tretene Business 4 Units Nuclear Systems: ,
- 1. Design, procurement and fabrication of Nuclear Steam Supply System (NSSS) components, systems and structures for NSSS contracts. ,
- 2. NSSS Licensing 3
- 3. 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, procurement and fabrication of nuclear fuel (both initial and reload cores) and related products and services. ,
Controller:
- 1. Administrative management duties, such as accounting.
-38 Revision 5 , . _ - , ~ . . . - - - , y_~ - ,,,, -. . . _ . - _ _ _ . . , , . . . . ,
f t c,
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- f. Table !!!-3 '
- . in NQA-1 and/or Regulatory Guide 1.28 (Rev. 03) '
gh A L ' _ , Section -46. " . 4. - ~ - 1
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~
Regulatory Guide 1.28 paragraph C.1 '" -" f " d - " ?'" i ^^ **"'- cr lla$$- A, . _' t - _ _,J.>>>> DEW ......%~'~' e [ A. p g g M '.ndividuals'are dualTfied in a
- nanner commensurate with the requirements of their job '
description, operating procedures . ! ensure that activities are. ' p accomplished at the correct inanection/ organization level; i
,7 thi h in lieu of personnel leveT ratings.
Regulatory Guide 1.28 The frequency of auditing a Paragraph C.3.2.1 supplier is based on:
- 1) if active work is in progress i under a purchase order,
- 11) results of quality trend ~
, evaluations, iii) quality classification of item or service. . , iv) processes being employed, ; v) item or service complexity ; or uniqueness, i vi) number of planned surveillances, vii) number of current orders. aa Y . W fee. NQA-1 Supplement 175-1 Record validationA.s controlled paragraph 2.3 b,y_,g. proc,edure. a-. .. ".4. 4.,,h ^" ^' " - ' n;;,
;_....... ^^ . R...................:..%_;-
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paragrnon 4.0 Applies only to records transferred to permanent storage (all other records are classified ds " Working" files). Revision 5
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- Preparation and control of Quality Plans.../...... . : .m -
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e Stop Work 0rder.......................... 7... /... g
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Indoctrination & Training of Personnel...j../...,.J.. -
"7'J Certification Program for Inspection,
, .. o 1 Examination and Testing Personnel........./..... ,
Certification Program for Audit Personnel. . '. ./ . . . . . F
- Certification Program for Nondestructive '
Examin'1 tion Pers onMel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 , ; a e Qualification of Registered Professional Engineers ' d,' D for ASME Code Certifying Activities.............. ' Establishment of Equipment Safety & ; Quality classifications.................C ....... .
;;g&pgag'sg'.Disciip51ay . . . . . . . . . . . . . . . . . . . . . . .
eDesign Input...................... / . . . . . . . . . , . . . . . . DesignAnalysis..............'...(............b....-
~
- Design Interface Contro1...........................
- . Design Verification................................
_ . . .
- Preparation, Control & Retention of Drawings....... ,',.
- Design Specifications.............................. . ,
q,1[c. . .:./3[ ' Design Change, Field Change, Corrective Action.....
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. + M Z desass a ~............................ '
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.' ,W iSafety Analysis Reports (SAR) and SAR Changes...... *
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,, Reports........................... f,j
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, Control of supplier Technical Change '
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Requests h m.................................. __y- - . M
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,' NUCLEAR POWER BUSINESSES REVISION.0 QUALITY ASSVRANCE PRCCEDUR ,
MANUAL ~ PAGE 2 OF 7 TABLE OF CONTENTS f (f, p & f 0 a x ' g' # w EFEECTIVE g/KTITLE REVISION
,/
DATF, f
.1 Preparation, Review & Approval of Purchase Orders........................,.)........ 0 ) 9/1/89 4 .'2 Dedication of Commercial Grade Items....J..........-(LATER) 5d e; r:"i - -' client centreste m ........h....t.....\0 9/1/89
,3 5.2 Preparation and Control of Quality , ,
Assurance Procedures............................ 0' 9/1/89
'O5.34 Pteparation & Control of operating i ,
s Procedures..............................N \' Os 9/1/89 5.4 Preparation & Control of Technical .- Operating Procedures....................,.'....... 0 9/1/89 l Preparation & Control of QA s' 55 specifications.................................. 0 9/1/89 x W \ h.-Gu.alwa risparation-Otride'ttnesr. . . . . . h 0, 9/1/89 6 .1' control of Quality Assurance Manuals.............. 0) 9/1/89 i ( 6.2 Preparation & Control of Contract operating Procedures.................. k......... 0 9/1/89 6.3 Preparation & Control of Welding '( Procedure Specifications........................'.0 9/1/89 f
' l.,1 Supplier Evaluation & S(election..........i........ 0 .
9/1/69 7.2 Approved Suppliers List........................... 0 9/1/89 7.3 Control of Supplier Document Submittals &
#cr 'gpre a1 er L . is- ( RAlW-h ecess. . .T70-
\ 9/1'/89
??*=*
7.4 control of Supplier Nonconformances v I R eietin. ' rec. c^a+ e n=" rn;u . ,/ \
'+DCR FProcess ...,..................... G._. .... 0 / 9/1/89
_ ~.-. J
- 7.5, ,
7.6 Source Surveillance......................... n.... 0\ 9/1/89 , 8'.1 CertificationofSatisfactoryCompletionofWork..0) 9/1/89 10,X Inspection................................. q .... 0 9 /1'./ 8 9 2 12.1 Control of Measuring & Test Equipment....... Q.....fLATER) .
\
l r 1
?' i NUCLEAR' POWER BUSINESSES REVISION O QUALITY ASSURANCE PROCEDURES MANUAL PAGE 3 OF 7 TABLE OF CONTENTS p ,
- y .
.- ) -. EFFECTIVE F
Wt, - -- 73 g . . .. - - ---- - #- . REVISION,,j g s- .. D Control of Nonconforming Items......N... 7.7.*....(LATER) 15.1 16.1 Corrective Action Report................. 7..... 0 9/1/89 16.2 Quality Trend Analysis..................i....... 0 9/1/89 i 111s Records Retention........................ b .. (r' s. % 9/1/89 17.2) Owner's Records Package (Purchased Items)......J.0 / .)' 9/1/89 Wner ' = "--^-d- Package.4Pield-Activities h ,4., 0 9/1/89 17.2 17.4 Control of N Symbol Stamping................ \..w .0(' 9/1/89
.9/1/89
~
18.1 Internal QA Audit.............................. 0
~
' 18.2 Supplier Audits............................ .""./ ... 0 9/1/89 s%
s' (%.... .
<0 LIST OF EXHIBITSL
. . . EFFEgrIVE
~ EXHIBIT NO. TITLE DATE
< -REVISION
, s N k .. L 2.1-1 Record of. Initial Indoctrination h 0 9/1/89 e and Training
- 2.1-2 Individu.1 QA) Program / Procedure 0 9/1/89j l Training Record l
l 2.1-3 Group Training Record 0 9/1/89 2.2-l' Certification Record 0 ( 9/1/89
%_ ~
(Test and Inspection) 2.2-2 Eye Examination Record , 0 9/1/89 (Test and Inspection) ) 2.3-1 Record of Aud'itor Qualification O. 9/1/89 2.3-2 Record of Lead Auditor Qualification ( 0 9/1/89 l 3.4-1 Eye Examination' Record .(NDE) 0 9/1/89 2.4-2 Certification Record
~...
(NDET 0 N
~' " '"~~~' 9 /1/ 8 9 l .-
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