ML20090K485
| ML20090K485 | |
| Person / Time | |
|---|---|
| Site: | 05200002 |
| Issue date: | 03/12/1992 |
| From: | ABB COMBUSTION ENGINEERING NUCLEAR FUEL (FORMERLY |
| To: | |
| Shared Package | |
| ML20090K482 | List: |
| References | |
| CENPD-210, CENPD-210-R07, CENPD-210-R7, LD-92-031, LD-92-31, NUDOCS 9203190033 | |
| Download: ML20090K485 (43) | |
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linclosure I to
, y I.D 92 031 i
i QUAISIT ASSURANCE l'ROGRAM TOl'ICAl, REl' ORT CEN1'D.210, REVISION 7 ;
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l AllSTRACT t
This report describes the quality assurance program employed by Aill! Combustion Engineering Nuclear Systems and Abil Combustion Engineering Nuclear Fuel for the supply of items and services subject to the requirements of 10CFR50, Appendix II.
The program is based on and is responsive to the requirements of ANSI /ASME NQA-1, " Quality Assurance Program Requirements for Nuclear Facilities (1983 rdition with Addenda la (1983))*; the ASME Boiler and Pressure Vessel Code Section 111, Nuclear Power Plant Components (1986 Edition), and the guidance in Regulatory Guide 1.28,
Quality Assurance Program Requirements (Design and Construction)" (Rev. 03).
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L Iille hgt.No i-Cover Sheet i i Abstract ii i Table of Contents 111
- 1. Introduction 1 l
- 11. Quality Policy 3 lii. Quality Assurance Criteria -$
111.1 Organization 5 -
111.2 Quality Assurance Program 6 111.3 Design Control 9 111.4 Procurement Document Control 17 111.5 Instructions Procedures and Drawings 18 f 111.6 Document Control 20 111.7 Control of Purchased items and Services 21 111.8 Identincation and Control of items 23 ,
111.9 Control of Processes 24 111.1 0 - Inspection 25 111. 1 1 Test Control 26 111.1 2 Control of Measuring and Test Equipment 27- :
111.1 3 llandling, Storage and Shipping 28 l 111.1 4 Inspection, Test and Operating Status 29 ;
Control of Nonconforming items 111.1 5 29 111. 1 6 Corrective Action 30 111.1 7 Quality Assurance Records 31 111.1 8 Audits 32 t
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-r e Table of Contents (Continued) ,
i Bars Egure No, Ijilc EagcEe, ;
111- Organitation CharoAllli Combustion 34 lingineering Nuclear Systems I
' 11 2 - _ Organization Chart AllB Combustion 35 lingineering Nuclear Fuel -
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' lli-1 Responsibilities of Quality Assurance 36 j
- Ill-2' Clarifications to NQA 1 and/or 37
' Regulatory Guide 1.28 (Rev. 03) 1113 - Typical List of Quality Assurance Procedures 38 !
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- 1. 1RTRQQUCTION l
i 1.1 httpeic This report describes the quality assurance program employed by Allii Combustion lingineering Nuclear Systems (NS) and Allis Combustion lingineering Nuclear Fuel (NF) for the supply of items and services subject to the j requirements of 10CFlW), Appendix 11.
1.2 Scens l
This report includes a description of controls employed at the facilities noted a below. Section 11 presents the commitment to quality and describes the quality !
assurance organization and responsibilities. Section ill describes the quality ,
assurance controls employed to address cach criterion of 10CFR$0, Appendix 11.
The controls apply to all facilities unless otherwise indicated.
The facilities and the activities involved at each facility include:
t Eacility Attirities Headquarters, Engineering services, nuclear Windsor, CT fuel design and NSSS design, (with offices also in procurement, testing, inspection, ,
Chattanooga, TN) repair and installation. ,
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Nuclear Fuel Manufacture of nucleae fuel ,
Manufacturing, pellets, fuel assemblies and i Windsor, CT and control clement assemblics and :
11ematite, MO associated activities i
ABil Electro- Design and manufacture of Mechanics, New instrumente: ion & control Britain, CT systems and associated activities ABil N:wington - Design and manufacture of Operations, mechanical systems and ;
.Newington, NH associated activities 1.3 Enision. Control Revisions to this report will be in accordance with the standards specined in >
10CFR50.55 (f) (3). Specincally; ;
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 irnplementation. !
L Responsibility for implementimg the above is assigned to A1111 Combustion Engineering Nuclear Systems.
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- 11. QUAL.1TY PolKX ;
i 11.1 l'alicyltattmet11 t The Presidents of Alm Combustion Engineering Nuclear Systems and Aill)
Combustion lingineering Nuclear Fuel have authorized the following statement ,
concerning quality assurance policy:
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" A primary objective of Allli Combustion Engineering Nuclear Systems and Allil l
Combustion Engineering Nuclear Fuel is to deliver to our clients defect free, 1 competitive products and services on time that fully comply with contract l requirements."
Quality Assurance management within NS and NF has the responsibility for defining their unit's quality assurance program and shall bring to the attention i of the President any quality problem that cannot be resolved within the normal :
1 execution of this responsibility.
11.2 .
Qulitylugnwse Greaniralien The Nuclear Systems and Nuclear Fuel organizations are shown in Figures 11-1 and 112.
Regardless of the specific organizational structure 'and organizational titles, Quality Assumnce (QA) management is responsible to assure that the QA policy, goals and otjectives are transmiued through levels of management and imposed on quality functions. lThis is accomplished by distribution of Quality Assurance Manuals which contain QA policy statements, i Page 3 Revision 7
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Restensibility for nuclear quality assurance rests with each unit's President and is delegated to QA management who may further delegate specific activities to their personnel. Such delegation includes authority to stop work for noncompliance to requirements. Stop work orders are dispositioned by QA and may be n 4rinated at any organization level and unit and executed at the level of a Manager, Director, Vice President or President for action, in all cases where personnel perform quality assurance functions, this delegation provides them authority and freedom to initiate, recommend or provide solutions to quality problems through management channels, Compliance with quality requirements is measured through planned surveillance j and/or audit activities and corrective action follow-up by quality assurance personnel. QA is independent of other organizations as shown in Figures 11-1 and 11-2. QA interprets quality related industry standards for intent and guidance and is responsible for assuring that all quality assurance related procedures used i comply with established QA requirements. Each unit participates in an inter-unit audit program to verify that each is implementing its quality assurance program as necessary for items / services provided to each other. When items / services are provided from one unit to another, management of the unit- providing the item / service is responsible for the work.
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111. - QUALDI. ASS 11RANCE CRITERIA l
l This section describes each of the eighteen (18) elements of the quality assurance f program.
111.1 Organization Ailli Combustion Engineering Nuclear Systems and Ailll Combustion
- Engineering Nuclear Fuel have headquaners at Windsor, Connecticut. These units supply nuclear systems, nuclear fuel and related services Each project under contract is coordinated by a Project, Program, or Task Manager. who is a member of either the Nuclear Systems or Nuclear Fuel i organizations. The Pmject/ Task Manager is responsible for coordinating and 4-documenting all project work, assuring conformance with contract requirements and maintaining communication channels with the client and all other participating .
organizations.
Quality Assurance management has direct access to the President of their unit (see <
Figures 11-1 and 11-2). Responsibilitics of QA are listed in Table 1111. These resp (msibilities are carried out through the QA staff and by coordination of all QA ;
activities. Details of responsibilities and interfaces among QA and other
- organizations are contained in QA manuals and procedures. These interface relationships address items such as auditing, investigation of quality problems and implementation of corrective action.
QA functions as an independent communication channel between senior management and line management. This. assures that senior management is ;
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g' B 't appraised of quality matters and that the QA staff receive and comply with ;
directives from the President, b
i QA management meets regularly with the QA staff to discuss quality issues, schedule quality efforts, establish goals and identify areas for improvements. ;
These meetings are normally held monthly but may be at shorter or-longer internals depend;ng on the signifi2nce of quality assurance activities and issues at that time. In addition, these mee'.ings are supplemented by reports from the QA management staff to the respective President.
The detailed organizational structure of QA as well as the number of personnel i in QA may change over time deperiding on quality needs as well as business needs. However, QA will not become involved in activities unrelated to QA thi.t would prevent full attention to QA matters when necessary, QA personnel selection is based on knowledge of operations; QA regulations, practices and standards; past working experience in QA or related activities in nuclear power or a similar high technology industry and education considerations, in addition, QA management assignments are also based on evaluated management experience in similarly responsible positions.- -
111.2 Quality Assutaaq.e Program -
-111.2.1 Summary Description The QA program desciibed herein is employed for the supply of items and servie subject to the requirements of 10CFR50 Appendix B. The program is based on and responsive to the requirements of ANSI /ASME NQA-1 " Quality .
Assurance Program Requirements for Nuclear Facilities", the ASME Code, and the vidance in Regulatory Guide 1.28, " Quality Assurance Program Requirements (Design and Construction)".' Alternatives to the explicit Page 6 Revision 7 4
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, requirements and guidance given in NQA 1 and/or Regulatory Guide 1.28 are described in Table 1112.
In addition to the above, the applicable elements of ASME NQA 2, " Quality Assurance Requirements for Nuclear Facility Application" are applied to activities associated with the ABB Combustion Engineering Nuclear Power Stina ed Plant Design (* System 80+ Standard Design" as descr; bed in CESSA:<-X' The ,
I application of NQA-2 requirements and/or those in ANSI N45.2 and itmsociated daughter standards for other than CESSAR DC activities is dependent on client contract requirements.
111. 2 . 2 Etegritm Conlml
,- The requirements of this program are implemented at each facility through QA manuals and procedures applicable to the activities conducted at each facility. All such documents- are reviewed, approved and controlled by QA to assure compliance wi6 ?rogram requirements. ,
f 111.2 .3 hahalinn of P l ottiun.fffectiveness l
The scope, status, implementation and adequacy of the QA program are assessed L by senior levels of management in .several ways. The President receives a monthly report from QA management covering major quality issues such as j significant internal and client audit findings, industry quality-related developments and quality improvement needs. Quality issues and assessments are discussed l*
during each President's staff meetings. An annual, independent assessment of the QA program is performed by persornc! outside the unit's QA organization. This assessment is documented and any corrective actions are identified and tracked.
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. v 111.2.4 &nonnel Indoctrination and Training 1
The responsibility for assuring that peisonnel performing activities affecting quality are suitably trained rests with the organization performing those activities. '
Detailed personnel training requirements for each facility are contained in QA procedures. QA is responsible for assuring that training requirements are met.
Indoctrination, training and quali0 cation of personnel performing engineeting, purchasing, fabricating, installing, handling, shipping and storing activities consists of at least:
o indoctrination in the purpose, scope and implementation of QA manuals, and applicable instructions and procedures through self study, o pro 0ciency tests and/or performance reviews, and/or on-the-job observations as determined by management, to determine adequacy of training and quali0 cation, o maintenance of proficiency by performance review, and/or reexamination, and/or retraining as determined by management.
Indoctrination, training and qualification of QA personnel verifying quality affecting activities consists of the three items above anu in addition the following:
o training and quali0 cation in the principles, techniques and requirements of the activity being performed. Documentation for these formal programs normally include the program objective, content, attendees, date(s) of the training or certification, and appropriate approvals.
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, i For all of the above, training and qualification is documented in certificates ar.d/or procedures that delineate the specific functions personnel are quali6ed to perform as well as the basis for the qualification.
111.3 DESIGN CONIXQL 111.3.1 Ecntral Quality assurance procedures are used to assure that design activities are carried out in a planned, controlled and timely manner and that applicable design requirements are established and correctly translated into design documents such as calculations, speciGcations and drawings.
These procedures provide speci6c instructions for accomplishment of design activities by dc6ning requirements for design inputs and outputs including:
o document format and content, o document identi0 cation, o review and approval, o design veriGeation, -
o issuance and distribution, o revision control, o indication of document status, o record retention.
The procedures apply to design / engineering activities including such disciplines as reactor physics; stress, thermal, hydraulic and accident analyses; compatibility of materials; accessibility for inservice inspection, maintenance and repair; fuel Page 9 Revision 7
design; instrumentation and controls design; and delineation of acceptance criteria for inspections and tests.
The procedures cover the total design process to assure that:
o appropriate design basis requirements including quality standards are selected, specified, and included in the design; o deviations from standards are controlled; o materials, parts, equipment, and processes (including commercially obtained items) essential to the safety-related functions of basic components are reviewed for suitability of application and compatibility with overall system design criteria; o design interfaces among participating organizations (both internal and external) are identified and controlled; o design work is verified or checked for adequacy:
o design changes, including field changes, are subject to the same degree of control as applied to the original work.
Compliance to design control procedures is monitored by QA internal compliance audits.
III 3.2 Design Innuts Design work begins with the definition of the design requirements or design bases information. These requirements come from several sources. Typical sources
-include previously approved designs, those from engineering and product development efforts, contracts (e.g., equipment peiformance criteria, design life, .
regulatory requirements, codes and standards, interface requirements, etc.),
Standard Safety Analysis Reports, topical report, and information from industry s
or government funded research activities.
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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 speciGed in contract documents, bid speci0 cations, regulations and industry stadards as applicable to the iespective efforts. Within the CO, specific tasks are established and assigned to cognizant engineers. The CO is responsible for selection and documentation of design inputs including the identification, substantiation and documentation of changes from previously ,
approved designs.
The CO assures that design inputs have been verified or annotated to clearly indicate data or assumptions that must be con 0rmed by later design efforts or tests and that the design inputs are traceable by reference to the source of the data. Design documents containing input data are approved by the author and verifier (s) of the documents.
111.3.3 Design Calculations / Analyses The CO is responsible for selection of input data and analysis method, juni0 cation of assumptions, and preparation of design calculations.
Documentation of design calculations is detailed in purpose, method, assumptions, design input, references and units so that a person technically qualified in the subject can review and understand the design and verify the results without recourse to the originator.
Computer codes (used in design analyses or supplied to clients) are uniquely identined, tested and verified to assure accuracy of method. Procedures are used to preclude use of unverified modi 0 cations. Sample problems used in the ,
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testing and verification of a given version of a computer code is documented and includes the- signature of the author and verifier (s) of the code testing l i
documentation. Dissemination of information on computer code errors is provided via a computer program error notincation system. Computer source codes are protected to preclude uncontrolled modifications.
A qualified individual or group is assigned to verify the design work (see 111.3.7, Design Verification). When a standardized or previously proven design is ued, ,
the verification process is not duplicated: however, the applicability of the standardized design is enecked with respect to meeting pertinent inputs. The ,
document includes provisions for unique identification and the signatures of the author (s) and verifier (sh 111.3.4 Design Soecifiqmimn The CO is responsible for the preparation of design specifications. These specifications contain a complete basis for construction of items in accordance with the requirements of the ASME Code, contractual documents, regulations, and other applicable information and, in conjunction with design drawings, contain all necessary information regarding materials and design. A design specification includes, as applicable:
o functions and boundaries of the items covered, o the design requirements including ~all required overpressure protection requirements, o the environmental conditions including radiation, o the safety classification of the items covered, o material requirements including impact test rcquirements, o operability requirements as appropriate.
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o- the effective ASME Code Edition, Addenda and Cases and other appropriate industry standards to be used for construction, o records required to be maintained, o special inspection, testing, and quality assurance requirements.
A qualified individual or group is assigned to verify the specification (see 111.3.7, Design Veri 0 cation). The document includes provisions for unique identi6 cation and approvals of the author and veriner(s).
111.3.5 Design Drawings e The CO is responsible for the preparation of design drawings. These drawings include functional requirements for system / component interfaces, arrangement and layout, which are not directly used for producing an item. Examples include:
piping and instrument diagrams, layout drawings, general arrangement drawings, and electrical diagrams. . A drawing request system is used to denne the scope and purpose for the drawing, the technical requirements to be incorporated and any special features or notes to be included. The CO reviews the design drawing for technical content and agreement with calculations, analyses, or other applicable design specincation requirements. Additionally, a qualified individual
, or group is assigned to verify the contents of the drawing (see 111.3.7, Design VeriDeation).
L 111.3. 6 DLher D.csigtLD.ocuments The CO is responsible for preparation of other design documents needed to define or describe engineering requirements. These documents typically include items such as: design bases or design data information; system descriptions; interface requirements: test requirements; guidelines for startup and operation; guidelines Page 13 Revision 7 ee4 <w-sw w w -.v%e-
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for installation; engineering studies; and software verification plans and results. I c A qualified individuel or group is assigned to verify the design docurnent (see 111.3.7, Design Verification). The document includes provisions for unique identitication and approvals by the author and verifierfs).
111.3.7 DesinnlaiDatinu Design output is reviewed to .erify its adequacy. This verification provides assurance that the output meets the specified inputs and is correct and complete.
Verification activities are performed by an individual or group other than those who performed the original work. In exceptional circumstances verification may be performed by the originator's supervisor, provided: the supervisor is the only technically qualified individual in the CO; the need is individually documented and approved in advance by the supervisor's management; the supervisor did not specify the design approach, and did not rule out certain design considerations; the supervisor did not establish the design inputs used in the design.
Audits by QA cover the frequency and effectiveness of the use of supenisors as design verifiers to guard against abuse, The CO determines the particular design verification method (s) to be used and designates the individual or group responsible for the verification efforts. The acceptable verification methods include design review, alternate calculation, and qualificadon testing and are defined as follows:
o Design ' Review - independent critical review to assure that the i
.information is correct and satisfactory.
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l o Alternate Calculation - preparation of calculations or analyses using alternate methods to verify by camparison the correctness of the original work.
o Quali0 cation Testing suitable testing of a model, prototype or initial production unit.
Qualification testing (as opposed to acceptance testing) is performed to test requirements established by the CO. The testing requirements include test conditions that simulate the most adverse design conditions (operating modes and environment) for the specific design feature (s) being verified. Test results are documented by the testing organization and evaluated by the CO to assure that test requirements have been met. When tests are being performed on models or mockups, scaling laws are established and verified and results are subject to error walysis when applicable prior to use in final design work.
Design Verification procedures address responsibilities of veri 0ers, items to be verified and documentation required.
Results of the veri 0 cation are documented, including identification of the veritier(s). Design verification is completed prior to relying upon the component, L
' system part or structure to perform its safety related function 111.3 .8 Revisipp control f Design document revisions are subject to the same review, approval and distribution controls as those applied to the original work. Revision level notation l is used to assure that obsolete. or' superseded documents are not used i.
inadvertently. Quality assurance procedures include requirements for evaluation of reported changes resulting from items such as:
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o qualification, preoperational, or operational test problems, i o interference problems during construction, o disposition of nonconformances, o revised inputs (i.e., changes in regulatory or customer requirements),
o . operational experience.
Where changes to previously verified work have been .made, veri 6 cation is repeated by the organi7ation currently responsible for the work or by an equally qualified organization having access to the pertinent information.
111. 3.9 Luitdatt. Control Quality assurance procedures contain the organizational structure within which the program is implemented and delineate the authority and responsibility of the CO's involved. The organizational interfaces among contributing CO's, (both internal ,
and external) are controlled in accordance with these procedures.
These procedures control the flow of design information by requiring the formal release of outputs involving interface information to other functional groups. This is accomplished internally by documented correspondence or standard document distribution forms and externally by letters or approved procurement documents.
The transmittal identifies the verification status of the information or document and, -where necessary, identi6cs -incomplete items which require further verification. Where it is necessary to transmit design information orally or by other informal means, follow-up by a centrolled document is provided, Interface communications are traceable from a request through a related response to assure completeness and accuracy.
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111.4 PROCUREbiENT DOCUMENT CONTROL, Controlled procedures are used for the preparation, review and approval of procurement documents. Groups that prepare, review and approve procurement documents are identified in the procedures. These groups include design groups (CO's per Section 111.3), procurement groups, and QA.
Procurement documents include (either directly or by reference) the following [
requirements, as applicable:
o regulatory, ASME Code and industry standards; o tests and inspections, including acceptance criteria; o- quality assurance program elements; o quality assurance records retention times and disposition; o reporting, approving and dispositioning nonconformances; o rights of access by NS and NF and/or its representative (s);
o documentation submittal, review and approval; o extension of requirements to sub-suppliers;
.o technical / design (including drawings and specifications);
.o. - administrative; and o special processing.
It is the responsibility of the organization that prepares the procurement document to assure that all required elements are addressed. Procurement documents are reviewed and approved by personnel trained in QA procedures prior- to issue.
This. approval is. also applicable to supplements issued to change the requirements of the original procurement.
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I The procurement process for commercial-grade' items and services uses the same ,
review and approval cycle. These are purchased to commercial standards where
- standards are available. Commercial items that become part of a system may be tested as part of the completed system. Procurement documents for standard >
commercial or previously approved items including spare or replacement parts essential to the safety functions of structures, systems, and components, are reviewed and approved by personnel trained in QA procedures.
, i 111.5 INSIRlLCILONL_12DfEDERES AND DRMINGS Quality affecting activities such as engineering, manufacturing, inspection, l testing, certification, handling, storage, shipping, etc., are prescribed by and ;
performed in accordance with documented instructions, procedures, or drawings 7
of a type appropriate to the circumstances. Quality assurance procedures ret,uie'
,- that these documents include or reference quantitative or qualitative acceptance criteria for determining that the activity has been satisfactorily accomplished.
The following is a summary of the types of instructions, p;ocedures, and drawings used to control quality affecting activities.
t Q.Alaamillfrssedpres r anMastructions - documents containing the systems and procedures that specify and describe the activities performed to provide adequate ;
confidence that an item or service provided meets applicable requirements. A typical list of QA procedures is given in Table III-3. ,
3 Controle 11rnited to those items and services to be subsequently dedicated as " basic components".
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4 Procurement Documents - documents that specify requirements for purchase of an item or service including purchase requisitions, drawings, process or material ,
specifications, procedures or instructions, Placsn control Dmme.n13 - documents that are used to control operations on items. These operations include: forming, machining, assembling, welding, brazing, heat treatment, examination, inspection, testing, plating, etc.. These documents include:
o Process Sheets / Travelers / Work Orders - contain steps and the sequencing ,
of operations performed to produce or install an item, 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, shipping, handling, welding, brazing, heat treatment, and similar special processes.
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III,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 quality requirements or that prescribe activities affecting quality. The procedures specify how documents are reviewed for adequacy, approved for release, and distributed to and used at the location where the prescribed activity is performed.
These procedures address items such as: ,
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- o identification of organizations responsible for preparing, reviewing, >
approving, issuing and revising documents. This includes design documents, Safety Analysis Reports, nonconformance reports, as built documents, and those documents identified in Section 111.5; L o use of distribution lists or equivalent to assure that the proper personnel f
or organizations are provided the required documents to perform the work; l!
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o document identification to assure that -the proper document is used in y performing a particular activity. The identification includes the document 1
number or any other relevant information that identify the document to be used; L o ascertaining that proper documents are accessible and are being used.
This is accomplished by use of document lists and/or files showing the latest applicable revision or use of receipt control systems or marking documents as obsolete. This assures that the latest applicable documents L have been received and obsolete revisions recalled or discarded, where appropriate.
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. e Changes to documents are reviewed, approved, and released by the organizations responsible for the work unless other organizations are specincally designated.
In all cases, the reviewing organization (s) has access to pertinent information or background data upon which to base approval.
Ill.7 CONTROL OF PURCllASED ITEMS AND SEIELCES Items and senices are procured from approved suppliers. QA procedures specify ,
requirements for supplier evaluation and selection, control of supplier generated documents, acceptance of the item or service (by documentation review, source $
surveillance, source and/or receiving inspection), control of nonconforming conditions, supplier performance evaluations (assessments and audits), and quali6 cation of audit, inspection and surveillance personnel.
When specified in procurement documents, surveillances are performed during fabrication, inspection, testing, and release of items and services. Quality procedures provide guidance for surveillance activities. Where no established quality standards exist for a specine supplier, the specine technical requirements of the procurement documents are used as the basis for surveillance. The degree of surveillance varies with the degree of importance of equipment, supplier performance, and complexity of items. The degree of surveillance is determined l
by- the organization that prepared the order and QA. This surveillance is -
performed using instructions which define the operation or process to be witnessed and the verifications to be made.
The procurernent of spare or replacements parts and components are governed by client order requirements.
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specific QA control cannot be imposed in a practical manner, specinc provisions are made during receiving inspection or source surveillance to verify that critical characteristics are met.
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i Initial supplier approval is via survey or evaluation that is conducted by QA. The purpose of this is to verify that the new supplier is capable of complying with the quality requirements in the procurement documents. The results are documented i and any identified deficiencies are resolved prior to starting work. In accordance with IE Information Notice 86-21, suppliers that have received ASME approval are considered " Approved Suppliers" on the basis of the ASME approval.
Supplier approval is maintained by annual evaluations and periodi: audits. The annual evaluations take into consideration items such as supplier furnished documentation; results of prior surveillances, inspections, and audits; and item or service operating performance. The periodic audits address the applicable criteria of 10CFR50, App. B and are normally performed on a triennial basis.
An alternative to the guidance in paragraph C.3.2.1 of Regulatory Guide 1.28 (Rev. 3) is given in Table 111-2.
For items shipped to a NS/NF manufacturing or warehouse facility, receiving and/or source surveillance procedures are used to assure that the item and specified documentation comply with the procurement document requirements.
Measures are established to assure that items accepted and released are identified as to their inspection status in order to prevent the use or installation of non-accepted items and allow entry of only accepted items into the warehouse. The status is identified on the item or on documentation traceable to the item.-
For items procured and shipped to a nuclear power plant site, QA issues a
- certification which indicates acceptance of the item. ~ The certi6 cation includes specific informatior, identifying the item and the applicable procurement documents, and certifies that the item meets all applicable procurement requirements, including documentation requirements. The certi6 cation includes identification of any ap; .,ved deviations from the procurement requirements and is approved by authorized personnel. Procedures identify the actions necessary to initiate, authorize, issue, distribute, and revise certifications. These procedures L include provisions for review and acceptance er supplier furnished documentation
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(e.g., certificates of conformances, certified material test reports, non-destructive examination reports) and for identifying and following-up contingent conditions that require additional action after delisery to the power plant site. - A contingent condition is any condition prohibiting the actual use of material or equipment for its specified purpose. Such items may be shipped to the client to permit partial testia 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 proside the means for evaluating supplier certificates of conformance to ensure that they are valid.
111. 8 iPJh'TJllCATION AND CONTROL OF ITla15 Identification requirements are controlled by procedures and are specified in the procurement and process control documents for quality related products and sersices.
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 lit, function or quality of the item supplied. Identification and contro! of items (including consumables)is the responsibility of the organization responsible for the item.
Identification of items is- traceable to documents such as design documents, procurement documents, mill test reports or inspection records. Identification of items is verified and documented prior to release of the item for further use.
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1 111.9 CONTROL _OF PROCESSES i l
Special processes include those inspection or manufacturing activities that satisfy the following:
o The results of which are highly dependent on the control of the process and/or skill of the operator; and >
o The quality of the activity can neither be determined by inspection, nor it is considered advantageous to perform destructive examinations or tests.
Special processes include activities such as welding, heat treating, non-destructive
. examination, and cleaning These type of processes are controlled by documents such as process sheets, travelers and special processing procedures which are ,
generated in accordance with QA procedures. These documents address items such as:
o process procedure, personnel and equipment qualification requirements o process prerequisites ;
.o acceptance criteria o environmental conditions
- l. Process procedures and/or control documents are approved by QA. Equipment and personnel associated with special processes are qualified in accordance with I applicable codes, standards, QA procedures and/or contract requirements.
Qualification records are reviewed by QA, and are maintained and kept current by responsible organizations. >
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4 4- 4 111.10 INSPECTION Inspections are performed in accordance with instructions, procedures and/or control documents which are reviewed by QA and approved by the responsible organization. These instructions / procedures provide criteria for determining accuracy requirements of inspection equipment, how and when inspections are performed, and mandatory inspection hold points beyond which work may not proceed until inspected by a designated inspector.
Inspections are performed by personnel other than those who performed or >
directly supervised the activity being inspected and who do not report directly to the immediate supervisors who are responsible for the activity being inspected.
The personnel performing inspections are trained, qualified and certified in accordance with procedures. The records of qualifications and cenifications of inspectors are kept current by the responsible organization.
Instructions and prwedures include, as appropriate, identification of characteristics and activities to be inspected, a description of the method 'of inspection, identification of the individuals or groups responsible for performing the inspection, acceptance and/or rejection criteria, identification of required procedures, drawings and specifications including revisions, special inspection r 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.
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111.!! IEST 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 procedures are submitted for review and approval prior to testing and the testing is witnessed by assigned and qualified personnel. Test procedures contain the following, as applicable:
o Provisions for assuring that prerequisites for the test have been met; o Required instrumentation and accuracies; o Instructions for conducting the test and for acquiring and recording the data necessary for evaluation; o Witnessing of the testing by qualified personnel; o Required environmental conditions; o Acceptance and/or rejection criteria required to evaluate the test; o Recording the performance of the test; o Use and identification of calibrated equipment; o Code and contract requirements; o Test personnel qualification; o Method of recording test results; o Verification that the test procedures have been reviewed and approved, Test procedures and/or controlling documents are approved by QA. Test results, as a minimum, identify the item tested, date of the test, the procedure and l
revision level, the tester or data recorder, identification number of the equipment, test conditions,. time, type of observation, results and acceptability, individual evaluating test results, and noted nonconformances. The test results are evaluated I and documented as specified in the test procedure.
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' 111.12 CONTROL OF MEASUJJING ANQ3 TEST IiOUIPMENT l
.J Gages, instruments, and other inspection, measuring and testing rouipment and J devices used in actisities affecting quality are required to be of the proper tange, -l 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 possible and practical, ,
measuring and test equipment are calibrated against standards that have an accuracy of at least four times the required accuracy of the equipment being calibrated. Greater uncertainty may be aceviable when nLited by " state-of-the-art". Where national standards do not exist far rcfererd standards, the basis of
' the calibration is documented.
The method and interval of canbra.un for each item is defined in procedures.
These are based on the type of ;ui nent, stability characteristics, required accuracy and-other conditions ri %cting measurement control. Each item is-identified to permit traceability to thc calibration test data. This identification may be by eitl> r lat ', tag or color coding, or other means as provided for by.
procedure. This Jentification also indicates the date of the next required calibration.
When an instrument is found to be out of calibration, an investigation- to determine the vahdity of previous inspections performed with the instrument and the' acceptability of ittms inspected a tested since the last calibration is ,
conducted. Inspections or tests are repeated on affected items as necessary.
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QA audits organizational units responsible for control of measuring and test equipment to assure compliance with applicable procedures.
111.13.liAMRIJRG. STORAGE A_ND SHIPPING Procedures are used to control handling, storage and shipping of items to ensure the maintenance of quality from source through delivery to the client. These procedures may be in various formats such as process sheets, travelers, work orders, drawings, shipping instructions, process speci0 cations, and instructions.
The proccoures 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, and shipping is based. upon considerations such as the level of sensitivity of the item to environmental conditions, its resistance to physical forces, and its relative replaceability. When required for particular items, special equipment (such as containers, shock absorbers, accelerometers and special tools or handling devices) and special protective environments (such as inert gas atmosphere, specific moisture content levels, and temperature levels) are speci6ed, provided, and
. verined when required. These special tools or handling devices are inspected, tested, and controlled in accordance with procedures. Only experienced or trained personnel are used to work with these devices.
Handling, storage, and shipping procedures and/or controlling documents are approved by QA. Equipment and personnel qualification records are audited by QA.
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i 111.14 INSEECTION. T.EST AND OPERATINE.SIATUS Documents, such as travelers, process sheets, and work orders are used for identifying required inspections, tests, examinations, and processing status of items. The documents indicate the status of the operation (s) being performed, the required signatures (or other similar means), and the date indicating when a given operatica, test, inspection, or examination was completed. Quality assurance procedures control the use of travelers, process sheets ad work orders including methods for making sequence changes and identification of nonconforming items.
No sequence change is allowed ifit compromises the safety function of the item.
Any change to travelers, etc. are subject to the same controls as the original.
These documents accompany items throughout processityg.
-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 QA is authorized to affix and remove inspection status indicators. This assures control of any possible inadvertent bypassing of required inspections, tests, and' operations. QA may waive certain check points, etc. at its discretion.
111.15 CDNQ'QL_OF NONCONFORMING ITEMS A nonconforming item is defined as .that which does not meet specified requirements.
Procedures are used to control the identification, documentation, segregation (when practical), review and disposition of nonconforming items (including computer codes), and include notification to affected organizations if disposition is other than scrap. These procedures identify individuals or groups, including Page 29 Revision 7
QA, authorized to disposition and approve' nonconformances, verincation requirements, and describe the segregation and/or control of nonconforming items to prevent inadvertent use. Nonconformances are resolved prior to shipment of an item.
Documentation contains the identification of the nonconforming items, a description of the nonconformance and its disposition including re-inspection requirements, and documented approval of this disposition. When nonconforming items are repaired or otherwise made suitable for their intended use, they are inspected or tested in accordance with the original inspection and test requirements or acceptable alternatNes.
Individu9s dispositioning nonconformances are selected based on experience and competence related to the item being evaluated, and rn understanding of the requirements. These individuals have access to necessa y background information.
I Nonconformances are periodically evaluated by QA for quality trends. Findings considered significant are reported to management for review and assessment.
Ill.16 CORRECTIVE ACTION Conditions adverse to quality, such as nonconformances, failures, malfunctions, deficiencies, deviations, or defective materials and equipment, are identified, '
documented and reported to appropriate levels of management. These conditions may be identided by suppliers, surveillance, inspection or audit activities at suppliers, internal audits / inspections, client audits, agency audits / inspections or p by independent investigations conducted by QA.
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QA procedures specify how conditions adverse to quality are documented and reported to cognirant parties, including appropriate levels of manage.nent, for action and for assuring that corrective action is suitably identified, accepted and implemented in a timely manner.
These procedures require identification of cause (as deemed necessary), corrective action to prevent recurrence, verincation of implementation, and follow-up and close-out ofinternal audit and supplier audit / surveillance audit findings. Follow-up action is :aken by QA to verify corrective action. QA concurrence with the action is documented.
Trend analyses are periodically performed on surveillance and audit activities.
Results of such analyses are reported to appropriate levels of management.
111.17 QUALITY ASSURANCE RECORDS Quality Assurance records are preplanneo, generated, stored, and maintained so as to provide objective evidence that quality assurance requirements have been met. The records program is planned for a standard system but may be expanded or specifically modified in accordance with individual contract requirements. The system includes provisions for records such as design, manufacturing, procurement, installation, inspection, and qualification. QA is responsible for the maintenance of permanent quality record files. Files are indexed to facilitate c storage and retrieval. The records are reviewed for completeness, per procedure requirements, prior to retention and are available for review by clients, for those
- records applicable to that client's contract. Unless otherwise authorized, suppliers are required to submit a copy of designated quality records for transmittal to the client (s) before the procurement order is concluded. Prior to shipment of a
- purchased item, the quality records compiled by the supplier are reviewed for -
f completeness and acceptability. The results of these reviews are recorded. Test Page 31 Revision 7 I
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results are reviewed and evaluated for adequacy, as necessary, during surveillance visits ta supplier's facilities.
III,18 AUDITS I
Intemal compliance atdits are performed by QA on applicable organization units at least once per calendar year. External audits of suppliers are performed by QA at a frequency commensurate with the supplier scope of supply and status and -
importance cr the supplier activity.
An annual audit - schedule is established indicating the frequency arid ory,anization(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 modined 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. .
QA personnel assigned to perform audits are qualified and certified prior to performing audits, ' All audits performed by QA are led by a lead audiar.
Qualification is based on training, education, experience, and successful completion of examination, . Auditors have no direct responsibility'in the areas audited. QA may employ qualified auditors from other organizations to perform audits and/or QA inay-use the results of supplier audits performed by other L organizations. However, QA retains responsibility for the audits in such cases,
- An a'udit plan identifies the area to be audited, audit scope, requirements, audit o
- l. personnel, organizations to -be notined, applicable documents, schedule, and L procedures or checklists to be used. The organization (s) responsible for the activity or area being audited is notified in advance of scheduled audits.
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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 o de 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 cognizant management.
If deficiencies are found during the audit the following actions are performed:
o The auditor documents the deficiencies in the audit report with a required response date, o The audited organization documents corrective action and returns the response to the auditor within the required response time.
o Auditors assure that deficiencies are answered in the allotted time and that
- adequate corrective action has been implemented or scheduled; verify the adequacy and completeness of corrective action; close out the 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, o incomplete corrective action responses are brought to the attention of the 1 applicable business unit management for resolution and if necessary to the President. Follow-up action is taken until corrective action is completed.
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_Etriidral AlllLComhudion EngincetincEudeat End HitccintJMd_linginectiot11'WB1 Ditcs10L.fucLDndeplnenLUlWlu. !
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[9nt Manager. Windser I
I Plant Manager. I!cmalilt l
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,- Controller and Othet. Administrative Positio_ns Figure 11-2 l Page 35 Revision 7
l Table 111 1 EnPa!151bilitkLef Quality AssVDMc o interface with all NS or NF organizations in the solution of day to day quality problems. <
o Provide the necessary direction for quality through approval and distribution of quality policies, manuals and procedures, o Provide an assenment of the scope, statur. implementation and adequacy of the QA program.
o Conduct the QA internal audit program.
o Provide interpretations for QA Standards.
o Interface with the U.S. Noelcar Regulatory Commission on quality policies, procedures and requirements.
o Perform quality data collection and trend analysis.
-o Maintain QA personnel training and qualification records, o Perform supplier evaluations, i o Perform audits at supplier facilities.
o Review resolution of deviations / nonconforming conditions.
o Review procuremant orders.
o- Establish and execute witness and hold points (surveillance and/or inspection). ,
o Monitor conformance to procurement requirements, t
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- Table 111-2 Clari0 cations and Alternatives to NQA 1 and/or Regulatory Guide 1.28 (Rev. 03)
Regulatory Guide _L2.8 Paragraph C.1 Yalning procedures are used to ensure that individuals are .
Clarific.eion *11ined 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 uwd in lieu of personnel level ratings.
Paragraph C.3.7.1 An audit of approved supplicis' quality assurance program is Alternative ronducted on a triennial basis unless:
i) there is no active work in progress (note: auditing will resume when work resumes); or -
e
- 11) documentation reviews and surveillance and/or insinctions and/or independent tests show acceptable quality assurance program implementation; or iii) the procurement is fo. ASME Code items from suppliers that hold valid ASME Certificates of Authorization or Quality Systems Cer1ificates. In this case acceptable quality assurance program implementation will be verified by documentation review and one or more of the following depending upon procurement scope and complexity:
a) audit b) surveillance c) insocction ,
d) independent test.
' NOA-1 SupphincDLllSd Paragraph 2.3 Record validation / authentication is by identi0 cation in -
Clari0 cation procedures and logging.
t l- Paragraph 4.0 Applies only to records transferred to permanent storage (all L Clarification other records are classified as " working" files). " Working" files
! are controlled to assure adequate preservation and safe keeping l while awaiting transfer to permanent storage, or the client, or L expiration of retention requirements. ;
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l Table 1113 Typical List of Quality Assurance Procedures o Preparation and Control of Quality Plans o Stop Work Order o Indoctrination & Training of Personnel o Certincation Program for Inspection, Examination and Testing Personnel o Certi5 cation Program for Audit Personnel l
o Certification Program for Nondestructive Examination Personnel o Quali6 cation of Registered Professional Enginects for ASME Code Certifying Activities o Determination of Quality Class o Design input ,
o Design Analysis o Design Interface Control o Design Verincation 4
-o Preparation, Control & Retention of Drawings o Specincations' i o Design Change, Field Change, Corrective Action :
o Safety Analysis Reports (SAR) and SAR Changes l 0 Design Reports o Control of Suppher Technical Change Requests
- o Preparation, Review & Approval of Purchase Orders ,.
i o Dedication of Commerelal Grade items o Preparation & Control of Quality Assurance Procedures Page 38 Revision 7 1
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Table 1113 (continued) o Preparation & Control of Operating Procedures o Preparation & Control of Technical Operating Procedures o Preparation & Control of QA Specifications o Control of Quality Assurance Manuals o Preparation and Control of Field Work o Preparation & Control of Welding Procedure Specifications o Supplier Evaluation & Approval (Approved Suppliers List) o Control of Supplier Document Submittals o Control of Supplier Nonconformances o Source Surveillance o Certification.of Satisfactory Completion of Work o Inspection o Control of Measuring & Test Equipment o Control of Nonconforming items 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 Interral Compliance Audits :
o Supplier Audits 4
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