ML20236X702
| ML20236X702 | |
| Person / Time | |
|---|---|
| Site: | 07201008 |
| Issue date: | 10/19/1994 |
| From: | HOLTEC INTERNATIONAL |
| To: | |
| Shared Package | |
| ML20236X700 | List: |
| References | |
| NUDOCS 9808100187 | |
| Download: ML20236X702 (86) | |
Text
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i O
HOLTEC INTERNATIONAL UNCONTROLLED COPY 1
HOLTEC INTERNATIONAL UAllTY ASSURANCE MANUAL l
O (HQAM) gggeigggg; gggjoos l
C PDR THIS l MANUAL' IS A" CONTROLLED : ISSUE" DOCUMENT.
UNCONTROLLED COPIES OF THIS MANUAL'ARE ISSUED ONLY O
FOR REFERE'NCE'PURPDSES ~AND ^RE NOT UPDATED.
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REVIEW AND CERTIFICATION LOG FOR HOLTEC QUALITY ASSURANCE MANUAL Approved ISSUE NO.
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i HOLTEC QUALITY ASSURANCE MANUAL NO.
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10 DATE 10-18-94 PAGE _1._ OF 4
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12-4-93 Note:
Starting with Revision 6 of the manual, a vertical bar to i
l the left of the text will indicate the text which was edited during the last revision of a particular page.
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HOLTEC QUALITY ASSURANCE MANUAL O
NO.
REV.
1 DATE 02-10-87 PAGE _i__ of xv INDEX Section Pace No.
Statement of Management Policy 11 Preface 111 Corporate Charter and Activity v
Definitions vi I
Organization 1
II Quality Assurance Program 6
III Design Control, Contract Administration 9
and Client Interface IV Procurement Document Control 16 V
Instructions, Procedures, and Drawings 20 VI Document Control 25 VII Control of Purchased Material, Equipment 29 and Services
()
VIII Identification and Control of Materials 34 IX Control of Special Processes 37 X
Inspections 38 XI Test Control 40 XII control of Measuring and Testing 42 Equipment XIII Handling, Storage and Shipping 43 XIV Inspection and Test Status 46 XV Nonconforming Materials, Parts, 48 or Components XVI Corrective Action 52 XVII Quality Assurance Records 55 XVIII Quality Assurance Audits 57 Exhibit A:
Review and Certification Log 60 Appendix A:
Listing of Quality Procedures 61 Appendix B:
Higher Basis, Policy and Procedure Matrix 62 i
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l HOLTEC QUALITY ASSURANCE MANUAL O
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8 DATE 12-4-93 PAGE 11 of xv NO.
l STATEMENT OF MANAGEMENT POLICY Holtec International-provides engineering design, analysis and consulting services to the power and process industries. The company also supplies fabricated equipment / components and provides field installation and repair services to the industry.
i For projects involving safety related services and products for nuclear plants, it is the policy of Holtec International to perform project activities in accordance with quality assurance practices described in the Holtec Quality Assurance Manual.
This l
l manual meets the applicable portions of 10CFR50, Appendix B,
l 10CFR71 Subpart H,
10CFR72 Subpart G,
and appliceble codes, standards, and regulatory requirements governing the control and monitoring of these products and services.
It is the responsibility of the President, Holtec International, to establish policies,
- goals, and objectives of the Quality Assurance Program and to assure that the program is being j
O properly implemented.
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The Quality Assurance Manager is responsible for establishing and maintaining a
Quality Assurance Program consistent with applicable regulations, codes, and standards, performing those quality-related tasks specifically assigned by the President, l
Holtec, and auditing the program for compliance.
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All Holtec personnel shall familiarize themselves with the contents of this manual.
Persons whose activities are governed l
by this manual are directly responsible for implementing the l
program and the procedures applicable to their activities.
l Tow r,l994 h h 0 54.9 L
Date K.P. Singh President I
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Holtec QUALITY ASSURANCE MANUAL No.
REV.
1 DATE 2-10-87 PAGE iii of _gy PREFACE 1
l The Holtec Quality Assurance Manual is the premier document which delineates c,uality related requirements in all aspects of a Holtec contract, such as interface of Holtec personnel with customer, development of Holtec operating procedures, management review of the quality program for evaluation of effectiveness, implementation of corrective action program, procurement document control, internal audit program, indoctrination of personnel, and reporting requirements of Federal laws (10CFR21).
The central goal of this Quality Assurance Manual may be broken down into three discrete items, namely:
(1)
To provide a clear and comprehensive description of the quality assurance commitments of the Holtec organization, in l
keeping with the Federal Codes (10CFR50 Appendix B, 10CFR71 l
Subpart H,
10CFR72 Subpart G,
and generally recognized industrial codes and standards.
(2)
To provide the framework from which Holtec Quality Procedures (HQP....)
can be evolved to control the day-to-day Q.A.
related functioning of the Holtec staff.
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I HOLTEC QUALITY ASSURANCE MANUAL NO.
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(3)
To provide a clear portrayal of the organizational layout and corporate activities to enable the customer's auditor to obtain a
good understanding of the company's corporate profile, and thus permit him to conduct an effective audit.
No documents, including the customer's design specification or purchase
- order, has primacy over this manual in matters of assurance of quality, unless such documents impose even stiffer requirements and are contractually imposed on a project by mutual l
consent of Holtec and the customer.
O This manua1 1s supplemented by a series of qua11er procedures labelled as HQP-1.1, 1.2, etc. where the first digit indicates the corresponding section of this manual.
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Mark Solar K.P.'Singh, P.E.
Quality Assurance Manager President en f
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HOLTEC QUALITY ASSURANCE MANUAL O
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e oxTE 7-17-89 rAoE v
of xv CORPORATE CHARTER AND ACTIVITY Holtec International is engaged in supplying engineering analysis, design and consulting services, engineered equipment, field installation and repair services on equipment, components / appurtenances for the power industry.
Engineered products and equipment and field installation / repair services are generally supplied through subcontracted manufacturing organizations and directly contracted field labor personnel that' are qualified in accordance with Holtec Quality Assurance Manual (HQAM) and Holtec Quality Assurance procedures (HQAP). Engineering analysis, design and consulting services are enerally performed by personnel directly and continuously employed by Holtec International.
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4 HOLTEC QUALITY ASSURANCE MANUAL J
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1 DATE 2-10-87 PAGE vi of rv O
DEFINITIONS I
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l Approval An act of endorsing, or adding positive authorization, or
- both, r
Appurtenance A part that is attached to a l
component which has been completed.
l As-Built Data Documented data that describe the condition actually achieved in a product.
ASME American Society of Mechanical' Engineers Assembly A combination of subassemblies
'Q or components, or both, fitted x
together to form a unit.
Audit An activity to determine through investigation the ade-quacy of, and adherence to, established procedures, in-structions, specifications,
- codes, and other applicable contractual and licensing re-quirements, and the effective-ness of implementation.
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DEFINITIONS Certificate of Compliance A written statement, signed by a qualified party, attesting that the items or services are in accordance with specified requirements and accompanied by additional information to substantiate the statement.
Certificate of Conformance A written statement, signed by a qualified party, certifying that items or services comply with specific requirements.
Certified Test Report A written document, approved by a
qualified
- party, that contains sufficient data and, information to verify the actual properties of items and the actual results of all required tests.
p Certification The act of determining, verifying and attesting to, in writing, the qualifications of personnel or material.
Characteristic Any property or attribute of an item, process, or service that is distinct, describable, and measurable, as conforming or nonconforming to specified quality requirements.
Quality characteristics are generally identified in specifications and drawings which describe the item, process, or service.
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i DEFINITIONS j
checks The tests, measurements, veri-fications, or controls placed on an activity, by means of investigations, comparisons or examinations, to determine satisfactory condition,
- accuracy, safety or performance.
Component A piece of equipment, such as a vessel, piping, pump valve, or-core support structure, which will be combined with other components to form an assembly.
Defective Material A material or component which has one or more characteris-tics that do not comply with
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specified requirements.
Deviation Written authorization to depart from a
particular re-quirement.
Documentation Any written or pictorial information describing, de-fining, specifying, report-ing, or certifying activities, requirements, procedures, or results.
Examination An element of inspection con-sisting of investigation of.
materials, components, suppl-lies, or services to determine 1
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l DEFINITIONS l
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conformance to those specified i
requirements which can be de-termined by such investiga-tion.
Examination is usually l
nondestructive and includes l
simple physical manipulation, gauging, and measurement.
Handling An act of physically moving material by hand or mechanical
- means, but not including transport modes.
Inspection A phase of quality control,
- which, by means of examina-tion, observation or measure-ments, determines the confor-
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mance of materials, supplies, components,
- parts, appurte-nances, systems, processes, or structures to predetermined quality requirements.
l Item Any level of unit assembly, including structure,
- system, subsystems, subassembly, com-ponent, part, or material.
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Manufacturer One who constructs any class of-component,
- part, or appur-L tenance to meet prescribed design requirements.
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>AoE of xv DEFINITIONS Material A substance of combination of substances forming components,
- parts, pieces, eiguipment, or items (intended to include machinery,
- casting, liquids, formed steel
- shapes, aggre-
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gates, cement, etc.).
Modification A planned change in plant de-sign or operation, accompli-I shed in accordance with the
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requirements and limitations of j
applicable codes, stand-dards, l
specifications, lican-ses, and i
predetermined safety j
restrictions.
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Nonconformance A deficiency in characteris-l tic, documentation, or proca-dure which renders the quality of an item unacceptable or in -
determinate.
Examples of non-conformances include: physical defects, test failures, incor-rect or inadequate documenta-tion, or deviation from pre-scribed processing, inspect-ion, or test procedures.
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objective zvidence Any statement of fact, infor-
- nation, or
- record, either quantitative or qualitative, pertaining to the quality of an item or service based on' observations, measurements, or tests which can be verified.
Package A wrapping or container in which material or equipment has been enclosed.
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Part An item on which work is per-formed and which is attached to, and becomes part of, a
Q component before completion of the component.
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Procedure A document that specifies or describes how an activity is to be performed.
It may in-clude methods to be
- employed, equipment or materials to be
- used, and sequence of oper-tions.
Procurement Documents Contractually binding docu -
ments that identify and define the requirements which items or services must meet in order to be considered acceptable by the I
i purchaser.
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2-1o- >
>Aoz xi1 of xv DEFINITIONS I
l Purchaser The organization or organiza-tions responsible for issuance and administration of a con-tract, subcontract or purchase order.
Qualification (Personnel)
The characteristics or abili-ties gained through training or experience, or
- both, that
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enable an individual to per-i l
form a required function.
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Qualified Party A person or organization rec-ognized as knowledgeable and competent to perform certain functions.
Q Qualified Procedure A procedure which incorporates l
all applicable codes and stan-dards, manufacturer's parame-ters, and engineering specifi-cations, and has been proven adequate for its intended pur-pose.
Quality Assurance All those planned and systema-tic actions necessary to pro-vide adequate confidence that an item or a facility will perform satisfactorily in ser-l vice.
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DEFINITIONS i
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' Quality Control Those quality assurance ac-
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tions which provide a means to control and measure the char-I acteristics of an item, pro-cess or facility against esta-blished requirements.
Receiving Taking delivery of an item at a designated location.
j Repair The process of restoring a
nonconforming characteristic to I
a condition such that the capability of an item to function reliably and safely is I
unimpaired, even though that item may still not con-form to i
the original require-ment.
Report Something (document) that gives information for record purposes.
Rework The process by which a noncon-forming item is made to con-form to a prior specified re-quirement by completion, re-machining, reassembling or other corrective means.
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.O DEFINITIONS l
l Source Surveillance A review, observation, or in-I spection for the purpose of I
l verifying that an action has
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l been accomplished as specified
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at the location of material procurement or manufacture.
Specification A concise statement of a set of requirements to be satis-fied by a
- product, material, or l
process indicating, when-ever appropriate, the proca-dure by which it may be deter-mined q
whether the require-ments given i
are satisfied.
1 Standard The result of a
particular-Q standardization effort appro-ved by a recognized authority.
Subsystem A group of assemblies or com-ponents, or both, combined to perform a single function.
Supplier Any organization under con-tract to furnish items or ser-vices.
It includes the terms
- Vendor, Contractor, Subcon-tractor, Fabricator, and sub-i l
tier levels of these where appropriate.
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DEFINITIONS System A group of subsystems united by some interaction or inter-dependence, performing many duties but functioning as a single unit.
Testing The determination or verifi-cation of the capability of an item to meet specified re-quirements by subjecting the item to a set of
- physical, chemical, environmental, or operating conditions.
Use-as-is A disposition which may be in-posed for a nonconformance when.
it can be established that the (V~)
discrepancy will re-sult in no adverse conditions and that the item under consi-deration will continue to meet all engineering functional re-quirements, including perfor-
- mance, maintainability,
- fit, and safety.
Verification An act of confirming, substan-tiating, and assuring that an activity or condition has been implemented in conformance with the specified require-ments.
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I REV.
1 DATE:
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ORGANIZATION PURPOSE To establish the authority and duties of persons performing activities affecting the safety-related functions of structures, systems, and components.
APPLICABILITY This policy applies to all safety-related activities.
POLICY The persons and organizations performing quality assurance functions shall have sufficient authority and organizational.
freedom to identify quality problems; to initiate, recommend, or provide solutions; and to verify implementation of solutions.
Such persons shall report directly to the Holtec president such that this required authority and organizational
- freedom, including Jufficient independence from cost and schedule when opposed to safety considerations, are provided.
The organization chart shown in Table I.1 delineates the line of authority of key HOLTEC personnel.
The Q. A.
responsibilities of all personnel listed in Table I.1 are summarized below:
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12 2 PAGE --- 2 of e3 ORGANIZATION PRESIDENT Approves proposed revisions to the Q.A. Manual and is ultimately responsible for all Q.A. actions of the Holtec organization.
VICE PRESIDENT ENGINEERING Has authority to assume Project Manager responsibilities on all Holtec safety related projects.
Has authority to conduct management audits of the Holtec Q.A. Program.
QUALITY ASSURANCE MANAGER Originates revisions to the Q.A.
Manual and QA Procedures.
Responsible for review of project documents prepared by Holtec International for their compliance to the requirements of Holtec's QA Program.
Responsible for indoctrination of Holtec personnel in the requirements of the Holtec QA Manual and in the requirements of the QA procedures invoked on Holtec projects.
O Assists Project Managers in developing the quality assurance surveillance requirements on safety related projects.
The QA Manager is responsible for overall maintenance and implementation of the Holtec quality assurance program.
PROJECT MANAGER Responsible for all project activities, including review of client purebase orders and work specifications, preparation of a project plan, review and approval of project documents, and coordination of the project team.
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ORGANIZATION i
CHIEF DESIGNER Responsible for preparing design and fabrication drawings and bills of material.
OA SECRETARY The QA Secretary is the
" hands on" person responsible for distribution of the QA Manual and QA procedures in accordance l
with controlled distribution lists.
The QA Secretary is.
l responsible for the preparation of project document transmittal l and project document dispos,ition forms, and for maintenance of l in-process project records.
O on sunvrrttiner Trix One or more individuals reporting to the QA Manager who reviews the activities of Holtec's suppliers on safety related projects I
for compliance with the quality assurance requirements involked in the procurement documents.
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ORGANIZATION BLANK PAGE l
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l HOLTEC QUALITY ASSURANCE MANUAL NO.
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7 DATE 12-4-93 PAGE 5
of 63 ORGANIZATION Table I.1 ORGANIZATION (Safety Related Projects)
PRESIDENT l
VICE PRESIDENT ENGINEERING O
or *^*^ ora I
PROJECT MARKETING OFFICE QUALITY MANAGER MANAGER STAFF CONTROL Q.A.
l SECRETARY l
CHIEF DESIGNER OTHER PROJECT QA SURVEILLANCE TEAM MEMBERS TEAM l
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HOLTEC QUALITY ASSURANCE MANUAL NO.
II REV.
2 DATE:
11-19-91 PAGE 6
of 63 QUALITY ASSURANCE PROGRAM QUALITY ASSURANCE PROGRAM PURPOSE l
To establish the basis for development of the Holtec Quality Assurance Program.
APPLICABILITY The Quality Assurance Program applies to all activities affecting the safety-related functions of those structures, systems, and I
components which prevent or mitigate the consequences of postulated accidents that could cause undue risk to the health and safety of the public.
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POLICY 1
This program is designed to be in conformance with the applicable l requirements of 10CFR50 Appendix B,
10CFR71 Subpart H,
and I
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l 10CFR72 Subpart G.
The conformance of this program with other j higher basis documents (eg. ANSI N45.2 series and NQA-1) may be j found in the " matrix" presented in Appendix B to this manual.
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HOLTEC QUALITY ASSURANCE MANUAL NO.
II REV.
6 DATE:
7-17-89 PAGE 7
of 63 QUALITY ASSURANCE PROGRAM l
l The Quality Assurance Program, as described in this manual, l
delineates the measures established by Holtec to assure that activities which affect the quality of safety-related structures, systems, components, and services are performed in a controlled l
manner and are sufficiently documented to provide objective evidence of compliance with established requirements.
The applicable requirements of the program are also imposed upon suppliers and consultants.
The Holtec Quality Assurance Manager has the direct responsibility for ensuring that this Quality Assurance Program is implemented and that it provides for control of all activities affecting quality on safety-related projects.
He is also responsible for ensuring that the program is modified and updated as standards, regulations, results, and experience dictate.
J The Holtec Quality Assurance Program is described by this Q. A.
Manual, and referenced Quality Procedures. The basic policy is established by the President in his Statement of Policy.
The Quality Assurance Manual and Quality Assurance Procedures Manual are issued by the Quality Assurance Manager.
A listing of the quality assurance procedures to be used to implement the Quality Assurance Program is includad in "Appandix A" to this manual.
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11 REv.
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oATE:
11-19-91
> AGE
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of e2 QUALITY ASSURANCE PROGRAM Because the quality assurance requirements of 10CFR50, Appendix-l B, 10CFR71 Subpart H,
and 10CFR72 Subpart G are considered by Holtec management to be descriptive of all the essential elements of a
total quality assurance
- program, the Holtec Quality Assurance Program is structured directly to meet these requirements on project-related work.
A project QA plan is developed for each safety related project to identify the applicable QA procedures to be used on the project.
I The Q.A.
Manager will corduct periodic indoctrination sessions I
with Holtec personnel actively involved in project execution.
These sessions will be aimed to foster a clear understanding of the intent and objectives and procedures of the Q.A.
program.
Indoctrination sessions must occur at least once a year and must be given to each newly hired Holtec employee.
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DESIGN CONTROL, CONTRACT ADMINISTRATION AND CLIENT INTERFACE PURPOSE To establish measures to assure that applicable regulatory requirements and design bases for safety-related structures,
- systems, and components are correctly translated into specifications, drawings, procedures, and instructions.
APPLICABILITY This policy applies to Holtec activities associated with the control of the design and design documents (including computer programs) for safety-related items and services.
s POLICY DESIGN INPUTS
. Procedures shall be established to ensure that design inputs (such as design bases, regulatory requirements, and codes and standards) are identified and documented in a timely manner and to the level of detail necessary to permit the design activity to be carried out in a correct manner.
Deviations and changes from the design inputs shall be controlled and documented.
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1 DATE 2-10-87 PAGE 10 of 63 DESIGN CONTROL, CONTRACT ADMINISTRATION AND CLIENT INTERFACE The design bases are specified in whole or in part by the customer's procurement documents which delineate technical and quality requirements.
Consequently, Holtec does not generally' develop a
separate design input document for contracted activities.
DESIGN PROCESS l
Design activities shall be accomplished in accordance with j
controlled job specifications, work instructions, planning l
- sheets, procedures, or any other suitable written format.
Appropriate quality standards shall be documented.
The design activities shall be documented in a
manner that permits reviewing,
- checking, verifying, and auditing by experienced personnel, such that the final design can be related to the j
source of the design input.
1 DESIGN ANALYSES
(
l Design analyses (including calculations, studies, and documented l
investigations or assessments) shall be performed in a planned, controlled, and correct manner.
Analyses shall be legible and in a
form suitable for reproduction,
- filing, and retrieving.
Analyses shall be sufficiently detailed as to purpose, method, 1
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NO.
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2 DATE 12-4-93 PAGE 11 of 63 l
DESIGN CONTROL, CONTRACT ADMINISTRATION AND CLIENT INTERFACE 1
i assumptions, design input, references, and units such that a person technically qualified in the subject can review and
{
understand the analyses and verify the results without recourse to the originator.
Analyses shall be identifiable by subject, i
l customer (job or contract),
system or component, originator, reviewer, and date; or by other data such that the analyses are retrievable.
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DRAWINGS I
Procedures shall be established for the preparation and control of drawings.
OTHER DESIGN DOCUMENTS Procedures shall be established for the preparation and control j of other design documents such as specifications and procedures, l as required.
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1-14-91 PAGE 12 of 63 O
QUALITY ASSURANCE PROGRAM INTERFACE CONTROL The assignment of responsibilities among the various design organizations and individuals involved in each contract shall be identified to the interfacing organizations and-individuals.
Organizations without independent quality programs cannot perform l.
design functions for Holtec's safety related projects.
Design / review functions may be performed by technically competent individuals that are not full time employees of Holtec International only in accordance with Holtec's QA procedures and only when qualifications of such individuals are reviewed and approved by the President or Vice President of Engineering and QA Manager of Holtec International.
Procedures shall be established for the control of design interfaces and for managing the flow of design information l
between Holtec, the customer, participating design organizations and qualified individuals contracted by Holtec International.
- Q Completed design output documents shall be submitted to the l
v customer for approval, or for information, as the contractual provisions may require.
Approval by the customer does not relieve Holtec of responsibility for meeting the requirements of l this Quality Assurance Program. Except as amended by contract 1
l provisions, calculations and analyses which Holtec deems to be proprietary and which support the design output documents will be available for customer review at Holtec's offices.
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I HOLTEc QUALITY ASSURANCE MANUAL NO.
III REV.
2 DATE 1-14-91 PAGE 13 of 63 O
oES1G couraOL, cournice io=1 1SrRar10 i o ct1Eur zurEaracE I
DESIGN VERIFICATION Procedures shall be established for reviewing,
- checking, confirming or substantiating the design by one or more methods to
-l provide assurance that the design is based on specified inputs l and meets the design requirements of applicable specifications, j
l codes, and standards. Design verification encompasses-the process l of checking.
Individual elements of design process, such as calculations and drawings, shall be checked.
checking shall be performed by competent individuals or groups other than those who r
performed the original design, but who may be ' from the same' l
organization.
The broader function of verification may be I
performed by the originator's supervisor provided that the supervisor did not specify a singular design approach or rule out iO certain design considerations and did not estae11sh the design i
inputs used in the design, or if the supervisor is the only l
individual in the organization competent to perform the verification.
Cursory supervisory reviews do not satisfy the intent of this policy.
However, if an element of the design is checked by someone other than the overall verifier, the verifier is not required to recheck the element.
Verification involves the adequacy of the overall design process.
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HOLTEC QUALITY ASSURANCE MANUAL
)
1 NO.
III REV.
8 DATE 12-4-93 PAGE 14 of 63
{
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DESIGN CONTROL, CONTRACT ADMINISTRATION AND CLIENT INTERFACE j
l l
RESPONSIBILITIES l
l The responsibility for controlling design work and design control f
1 activities for safety-related projects shall be assigned to the 1
Project Manager.
The Project Manager is responsible for ensuring j that appropriate design control procedures are prepared and I
l implemented and for incorporating appropriate design control practices, checks, and reviews.
In particular, these procedures f
shall include:
design considerations and design review requirements; internal and extertal interface control
]
consideration; and design documer.t
- review, approval, distribution,
- control, and revision requirements.
Design' considerations-
- include, as appropriate,
- physics, stress, materials, thermal, hydraulic, radiation, and accident analysis;
)
appropriate design bases, codes, standards, and regulations; and O
accaveance and resection criteria.
l
)
Project Manager is responsible for use of proper codes, material specifications, etc., in the conduct of the project.
The Project Manager shall be responsible for the maintenance and issuance of design documents generated in the execution of the
- project, in accordance with document control and quality assurance records procedures.
The Quality Assurance Manager shall be responsible for the, quality assurance review of design documents, and changes thereto for compliance with Holtec quality assurance procedures. Design activities shall be audited by the Q. A.
Manager to verify that the implementing steps of the design control procedures are being met.
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1 HOLTEC QUALITY ASSURANCE MANUAL NO.
III R E V..,,,,,_ 2,,, DATE 1-74-91 PAGE 11_,,,,of 63 O
DESIGN CONTROL, CONTRACT ADMINISTRATION AND CLIENT INTERFACE l
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HOLTEC QUALITY ASSURANCE MANUAL NO.
IV REV.
1 DATE 2-10-87 PAGE 16 of 63 PROCUREMENT DOCUMELT CONTROL PURPOSE To establish measures to assure that applicable regulatory requirements, design bases, and other requirements which are necessary to assure adequate quality are suitably included or referenced in the documents for procurement of
- material, equipments, and services whether purchased by Holtec or by its contractors and subcontractors.
APPLICABILITY n
This policy applies to all Holtec activities associated with the V
preparation, review, approval and control of procurement documents, including changes, which contain the necessary information for' supplier compliance with the purchase request and applicable regulatory, code, and industry standard requirements.
To the extent necessary, procurement documents shall require contractors or subcontractors to provide a quality assurance program consistent l with 10CFR50 Appendix B, 10CFR71 Subpart H, and 10CFR72 Subpart G, j as applicable.
POLICY Procedures shall be established to delineate the sequence of actions to be accomplished to control the preparation, review, O
HOLTEC QUALITY ASSURANCE MANUAL i
i NO.
IV REV.
- __1_,
DATE 2-10-87 PAGE 17 of 63 PROCUREMENT DOCUMENT CONTROL i
l approval and issuance of procurement documents for safety-related items and services.
I I
The procedures shall require that all procurement documents include provisions for the following, as applicable:
I A statement of the scope of work to be performed by the supplier.
Identification of the design basis technical requirements by reference to specific
- drawings, specifications,
- codes, I
regulations, industry standards, or other documents that describe the items or services to be furnished.
1 Identification of
- test, inspection, and acceptance n/
L requirements, and any special instructions and requirements for such activities as design, fabrication, identification,
- cleaning, erecting, packaging,
- handling, shipping, and extended storage.
Identification of the Quality Assurance r2quir2:ent: 'thich must be met by the supplier.
Stipulation that the provisions of 10CFR21 apply.
l Identification of the documentation (such as
- drawings, specifications, procedures, fabrications and inspection plans, i
inspection and test
- records, personnel and procedure qualifications, and chemical and physical test results) to be prepared and maintained by the supplier and requirements for submittal to Holtec for review and approval.
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HOLTEC QUALITY ASSURANCE MANUAL NO.
IV REV.
2 DATE 2-01-91 PAGE 18 of 63 f
Q PROCUREMENT DOCUMENT CONTROL l
l Identification of those records to be retained, controlled, and maintained by the supplier and those to be supplied prior I
to use of the procured item or services.
l l
Holtec's and the customer's right of access to the supplier's l
facilities and records to facilitate inspection and audits, as deemed necessary.
l Extension of applicable requirements to lower tier suppliers, j
including Holtec's right of access to facilities and records.
]
Reporting and approving
" accept-as-is" or
" repair" dispositions of nonconformances.
Holtec's right to hold shipment if procurement document requirements, including those of documentation, have not been fulfilled.
4 Q
The procedures shall require that procurement documents are prepared, reviewed, and approved by competent personnel prior to issuance.
Furchase requisitions shall be prapared by ccmpetant perscnnel cn l the Project Team for the procurement of materials,
- parts, components, or services.
The person initiating a
purchase requisition shall ensure that all applicable items listed above are included in the requisition and associated specifications / drawings.
The Quality Assurance Manager, or his designee, shall review and approve the purchase requisitions and O
HOLTEC QUALITY ASSURANCE MANUAL NO.
IV REV. __2_ DATE 2-01-91 PAGE 12__ of 63 O
PROCUREMENT DOCUMENT CONTROL invoked requirements to establish conformance to the Q.A. Manual.
The quality assurance review of. the requisition includes checks to verify that proper codes, regulatory requirements, material specifications (ASME,
- ASTM, ILWS,
etc.)
are
- invoked, that appropriate acceptance ' or rejection criteria are incorporated, and that Quality Assurance Manual requirements are incorporated.
In
- addition, purchase requisitions for the procurement of materials,
- parts, components, or services for safety-related j projects shall be approved by the Project Manager or his j designee.
Purchase orders shall be issued only after the purchase requisitions have received the required approvals and concurrences descriLed above.
Changes to purchase requirements shall receive the same review and approval as the original requisition.
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HOLTEC QUALITY ASSURANCE MANUAL O
NO.
V REV.
1 DATE 2-10-87 PAGE 20 of 63 INSTRUCTIONS, PROCEDURES AND DRAWINGS PURPOSE To define the requirements associated with prescribing and' accomplishing activities which affect qua_ity through written instructions, procedures, and drawings.
APPLICABILITY This policy is applicable for all safety-related activities and prescribes the requirements for developing instructions, procedures, and drawings for quality related activities as required by this sanual.
POLICY Measures shall be established and documented to assure that activities affecting the quality of safety-related items and services are appropriately prescribed in controlled instructions, procedures, and drawings and are accomplished in accordance with these documents.
l Instructions, procedures, and drawings are prepared, reviewed, approved, and distributed prior to the start of the activity.
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HOLTEC QUALITY ASSURANCE MANUAL O
No. _ v
=Ev-1 oirE 2-1o-=>
PioE 21 of ra---
INSTRUCTIONS, PROCEDURES AND DRAWINGS The content and extent of detail contained in the instructions, procedures, and drawings shall be based on the complexity of the work to be performed and the understanding, skill, and knowledge l
of the user.
Instructions, procedures and drawings shall include acceptance criteria for verifying that the activities have been.
satisfactorily accomplished.
Procedures shall be established which define the responsibilities and delineate the sequence of actions to be accomplished in the preparation,
- review, approval, and control of instructions, j
procedures, drawings, and associated changes or revisions.
The HOLTEC Quality Assurance Program procedures are designed to provide those detailed written instructions necessary to ensure l compliance with 10CFR50, Appendix B, 10CFR71 Subpart H, 10CFR72 I
l Subpart G, and the Holtec Quality Assurance Manual.
The Quality f
Assurance Program procedures shall be prepared by the Quality Assurance-Manager and approved by the President.
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I HOLTEC QUALITY ASSURANCE MANUAL NO.
V REV.
1 DATE 2-10-87 PAGE 22 of 63 i
INSTRUCTIONS, PROCEDURES, AND DRAWINGS RESPONSIBILITIES The appropriate Project Manager is responsible for ensuring that administrative instructions are prepared, reviewed, approved, and implemented in accordance with this Quality Assurance Manual.
For certain projects, the Project Manager may prepare, for his Project Staff, work instructions of a general-information nature that delineate work scope, schedules, task assignments, client-interface requirements, etc.
The Project Manager is responsible for the issuance and approval of specifications and drawings relative to modifications to safety-related structures, components, and systems associated.
O with the pro 3ece, in accordance vith Section III cDesign Contro1, i
Contract Administration and Client Interface), and this section (V).
These documents require that those individuals performing the work have and follow appropriate instructions, drawings, and j
procedures.
I I
Individuals who prepara and approve documents are responsible for ensuring that specifications, instructions, procedures, and drawings include appropriate quantitative and/or qualitative acceptance criteria.
These individuals are also responsible for assuring that the documents are maintained up-to-date.
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HOLTEC QUALITY ASSURANCE MANUAL No.
V REV.
2 DATE 1-14-91 PAGE 23 of 63 INSTRUCTIONS, PROCEDURES AND DRAWINGS The Quality Assurance Manager, or his designes, is responsible for the review of specifications and drawings, and any changes thereto, for compliance with quality assurance requirements.
The Quality Assurance Manager, or his designee, is responsible for preparing and implementing quality assurance control procedures.
The procedures, and changes thereto, require the approval of the President, Holtec, and are reviewed by others when appropriate.
Surveillance of the implementation of instructions, drawings and procedures is the responsibility of the Quality Assurance Manager.
l Standard and Proiect Procedures All Holtec operating procedures bear a unique identifying number.
Tnere are two croad categories of operating procedures, namely 1.
Standard Procedures (HSP) 2.
Project Procedures (HPP)
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HOLTEC QUALITY ASSURANCE MANUAL NO.
V REV. 1 DATE 2-10-87 PAGE 24 of 63 O
i INSTRUCTIONS, PROCEDURES AND DRAWINGS As the name
- implies, the standard procedures are generic documents, their numbering sequence is HSP-101, HSP-102, etc.
l The Project Procedures are project specific. They are numbered as HPP- (Project Number, five digits) - 1, HPP- (Project Number)
-2, etc.
The review and acceptance process for both HPP and HSP are identical.
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HOLTEC QUALITY ASSURANCE MANUAL NO.
VI REV.
1 OATE 2-10-87 PAGE 25 of 63
!O DOCUMENT CONTROL PURPOSE To establish measures to control the issuance of documents, such as instructions, procedures, and drawings, including changes thereto, which prescribe activities affecting quality.
APPLICABILITY This policy applies to all documents affecting the quality of safety related items or services.
POLICY O
Procedures sha11 de eseah11shed ana ing1emented to provide for the control of documents, including changes
- thereto, which prescribe the activities affecting quality or safety.
Documents required to perform a specific activity shall be available at the location where the activity is to be performed during the work activity.
Obsolete or superceded documents shall be controlled to prevent their inadvertent use.
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HOLTEC QUALITY ASSURANCE MANUAL 1
NO.
VI EEV.
1 DATE 2-10-87 PAGE 26 of 63 DOCUMENT CONTROL IMPLEMENTATION A Holtec procedure for document control shall be prepared in accordance with this Quality Assurance Manual and shall be approved by the President, Holtec International.
Each Project Manager is responsible for the implementation of the procedure for his project (s).
The document control procedure shall assure that documents (including changes) are reviewed and approved for release by authorized personnel.
A Project Managers are responsible for identifying those documents
(,)
that define or affect the quality of work performed by Holtec and their clients.
Document control measures shall provide for the following:
Identification of individuals or groups responsible for preparing, reviewing, approving, and issuing documents i
I and revisions; identification of the correct document and revision to be l
used in performing an activity; l
coo.
' ' ion of interface documents; verification that correct documents are being used; and O
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HOLTEC QUALITY ASSURANCE MANUAL NO.
VI REV. __1_
DATE 2-10-87 PAGE 27 of 63
.O DOCUMENT CONTROL identification or retraction of obsolete documents, and maintaining current distribution lists.
Document changes shall be reviewed and approved in the same manner as the original document. The individuals or groups performing the review shall have access to pertinent background information and shall be competent to evaluate the intent and requirements of the original document.
Types of documents that are controlled to various degrees include Quality Assurance manuals, procedures, specifications, drawings, inspection and test
- results, procurement documents, quality O
assurance
- records, nd nonconfornance and corrective action documentation.
l The Quellity Assurance Manager is responsible for the implementation j
of the document control system for all instructions, procedures, drawings, and other controlled documents received or prepared at the Holtec office for use in administering safety-related projects.
The Quality Assurance Manager shall ensure that no changes are mada l
to instructions, procedures, and drawings unless such changes are approved.
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HOLTEC QUALITY ASSURANCE MANUAL NO.
VII REV. _2__ DATE 12-4-93 PAGE 28 of 63 0
j DOCUMENT CONTROL l
\\
l The Quality Assurance Manager is responsible for quality l assurance review of, and concurrence with analysis reports, l drawings, procurement documents, procedures, etc., and therefore, document control requirements.
He is further responsible for review, inspection, surveillance, and audit, as appropriate, of the document control system.
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HOLTEC QUALITY ASSURANCE MANUAL NO.
VII REV. _.1._ DATE 2-10-87 PAGE 29 of 63 O
CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES PURPOSE To establish measures to assure that purchased
- material, equipment, and services, whether purchased directly or through contractors
&nd subcontractors, confor3 to the procurement requirements.
1 APPLICABILITY The requirements of this policy apply to all safety-related material, equipment, and services procured.
)
i POLICY General Measures shall be established, implemented, and' documented to assure that purchased material, equipment, and services (whether procured directly or through suppliers) conform l
to the procurement documents.
These measures shall include l
provisions, as appropriate, for source evaluation and selection, objective evidence of quality furnished by the supplier, and quality surveillance and audit at the source.
l Source Evaluation Procedures shall be established to provide for the selection of suppliers based on one of the following:
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i HOLTEC QUALITY ASSURANCE MANUAL NO.
VII REV.
6 DATE 7-17-89 PAGE 30 of 63 O
CONTROL OF PURCHASED MATERIAL, EQUIPMENT AND SERVICES f
An evaluation of supplier technical and quality capability by, review of the supplier's history of providing a product which performs satisfactorily in use as evidenced by experience of others.
An evaluation of the supplier's technical and quality capability by review of the supplier's history of providing a product to Holtec which meets requirements of purchase specifications as evidenced by records of receipt inspection, facility surveillance, independent laboratory analysis, and performance testing where applicable.
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- ""i
- a"* **v capability as determined by a review of the quality assurance 4
program and evaluation of the supplier's facilities and personnel.
surveillance and Audits - Quality surveillance procedures shall specify the requirements for witness and hold points and those l
responsible for implementing the quality surveillance.
Audits shall be performed as required.
Verification Documentation The records shall include documentation that identifies the purchased item or service and the specific procurement requirements which have been met as well as documentation which identifies procurement requirements which have not been met.
Such documentation shall include a description of t
those nonconformances dispositioned " accept-as-is" O
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HOLTEC QUALITY ASSURANCE MANUAL No.
VII REV.
6 DATE 7-17-89 PAGE
.,_21.__ of 63 O
CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES l
1 or " repair".
Where supplier certificates of conformance are used to identify the requirements met by the item, the certificates of conformance shall be periodically evaluated by
- audits, independent inspections, or tests to assure that they are valid.
l IMPLEMENTATION The four major procurement program elements (procurement i
documents, supplier selection, supplier surveillance, and receipt inspection) shall be utilized by Holtec in the control of purchased
- material, equipment, and services.
These program elements shall be used for the procurement of
- material, equipment, and services only for safety-related projects.
The use and control of procurement documents are covered in Section IV of this manual.
J l
Holtec shall maintain an Approved Suppliers List.
Suppliers of materials, equipment, and services must be on the Approved l
Suppliers List prior to commencement 'of work on safety-related i
projects for Holtec and must be reevaluated every three years to' maintain their approved supplier status.
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i HOLTEC QUALITY ASSURANCE MANUAL NO.
VII REV.
7 DATE 1-14-91 PAGE 32 of 63 PROCUREMENT DOCUMENT CONTROL The depth of the evaluation of a supplier being considered for the Approved Suppliers List shall
- vary, depending on the complexity and importance to safety of the items the supplier l
furnishes.
The supplier's technical capability to produce the i
design, service, item, or component delineated in the procurement document shall be evaluated by the Holtec project engineering
- staff, as necessary, while the supplier's overall quality assurance organization and program shall be evaluated by the Holtec Quality Assurance Manager.
l The Quality Assurance Manager and the Project Manager shall j
document the results of the supplier evaluation in a joint report that discusses areas investigated, results, and conclusions.
If satisfactory, the supplier is added to the Approved Suppliers List.
Concurrence of both Holtec Project Manager and the Quality, Assurance Manager is required to place a supplier on the Approved Suppliers List, and either is authorized to remove a supplier from the list without concurrence of the other.
O Products and
- services, other than design
- services, may be procured from suppliers under direct control of Holtec's QA program in accordance with Holtec's QA procedures, if the supplier's QA program has not been evaluated, or if evaluated, does not meet all of the QA requirements for safety related work.
Metal fabricators who maintain an ASME "N" or "NPT" stamp may be added to the Approved Supplier's List by the QA Manager upon
, presentation of current certificate / stamp holder status j documentation with. concurrence of a Project Manager. Material suppliers who maintain a valid Quality system certificate may be l
placed on the ASL after presentation of a valid certificate, but at a minimum will require random material testing by Holtec on l
l purchased material.
1 As required, based on the complexity of the purchased material or i
equipment, Quality Assurance 'shall conduct surveillance of l
supplier activities during the fabrication of materials and l
equipment to provide a sample review of the supplier's compliance' l
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HOLTEC QUALITY ASSURANCE MANUAL O
=0.
vrr REv.
2 DATE 1-14-e1 PioE 22 of e2 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES with quality assurance requirements.
The Holtec Quality Assurance Manager and Project Manager shall jointly determine if surveillance is required, and, if so, shall develop surveillance plans that identify areas to be reviewed.
Quality Assurance shall document the results of each surveillance, trip by means of a trip report, which shall be distributed to the l Holtec' Project Manager.
When a deviation from purchase order requirements is noted, Quality Assurance has the authority to inform the supplier that a particular item is unacceptable to Holtec and shall issue a nonconformance report.
The Quality Assurance Manager shall maintain a file of all q
supplier surveillance reports.
These reports shall be used to U
determine the continuing qualification status of the supplier.
Materials and articles received from suppliers shall be subject to inspection upon receift.
The Project Manager responsible for the procurement shall determine the type and degree of inspection j
to be performed to assure compliance with the purchase order and l
its included criteria and requirements.
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HOLTEC QUALITY ASSURANCE MA!WAL NO.
VIII REV.
1 DATE 2-10-87 PAGE 34 of 63 IDENTIFICATION AND CONTROL OF MATERIALS I
PURPOSE To establish measures to control identification and control of materials.
APPLICABILITY The provisions of this section will apply when Ho.tec purchases, safety related material for its client.
POLICY O
Holtec shall exercise controls to prevent the use, or submittal to clients, of incorrect or defective items, or of items that have not received the required reviews, inspections, or tests.
The identification and control requirements, which shall be established by a Holtec quality assurance procedure, cover items such as the following:
Traceability to associated documents such as drawings, specifications, purchase orders, inspection documents, or physical and chemical mill test reports; and the proper identification of materials,
- parts, and components prior to release for manufacturing, shipping, construction, and installation.
HOLTEC QUALITY ASSURANCE MANUAL O
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IDENTIFICATION AND CONTROL OF MATERIALS Materials and components fabricated for, or purchased by, Holtec shall have their identity uniquely established either on the item or by tags or records traceable to the item.
The fabricator shall be required to maintain records of the inspection status of materials,
- parts, and components throughout fabrication, assembly, storage, shipping and installation.
l The identification for software shall be on the documents, in accordance with Holtec procedures.
The identification system for fabricated items shall maintain traceability to subcomponents j
l and/or materials.
Inspection tags or appropriate documentation j shall be used to show the status of inspections and tests O
i performed on individua1 ite e for eafety-retated prosecte.
This system shall be utilized during all phases of a project.
Indication of quality status shall normally be by records traceable to the item and by a method acceptable to the Project Manager and the Quality Assurance Manager.
The method shall provide identification traceable to the person performing the verification of quality.
(
Items or materials that are inspected by Holtec, or its agents, 1
l shall be identified as acceptable, nonconforming, rejectable, or on hold, as appropriate.
Material bought to specification (s) i 4
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HOLTEC QUALITY ASSURANCE MANUAL No.
VIII REV.
1 DATE 2-10-87 PAGE 36 of 63 0
IDENTIFICATION AND CONTROL OF MATERIALS shall be identified through receiving and storage with the specification number and control number.
Where
- required, certificates of chemical and/or physical properties of material (s) shall be identified with the finished item, or with test results and analyses on the material.
Controlled storage shall be provided and maintained for all conforming and nonconforming items to assure that only acceptable items are
- used, and that deterioration from an acceptable condition shall not result from handling or storage conditions.
Suppliers shall be required to establish and use material control procedures in accordance with applicable quality and procurement document requirements equivalent to those of Holtec and subject to the approval of Holtec.
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HOLTEC QUALITY ASSURANCE MANUAL NO.
IX
_,REV.
3 DATE 12-4-93 PAGE 37 of 63 CONTROL OF SPECIAL PROCESSES l
PURPOSE To establish measures to control special processes in all Holtec safety-related contracts.
APPLICABILITY This policy applies to all Holtec activities pertaining to performing or obtaining services involving special' processes.
POLICY The Project Manager is responsible, through the preparation of procurement documents, for requiring suppliers to control special processes in accordance with applicable codes, standards, and j design specifications.
Holtec, as well as its suppliers, shall l perform special processes in accordance with written procedures.
The suppliers shall submit special process procedures to Holtec for review and approval prior to performing any special processes O
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9 rt - or co=9oaat aurctura ror "att c =a1==
Holtec QA determines that the vendor's quality assurance program meets the requirements of this section, in which case the Holtec project team shall determine whether procedure submittal is i
required.
Holtec special process procedures are reviewed for compliance with quality assurance requirements by the Quality Assurance
- Manager, and are approved by Holtec engineering personnel. Holtec may impose its own special process procedures on its
- supplier, in which case the supplier must be properly l
qualified.
The qualification records of personnel conducting the special processes shall be in accordance with the application design specification requirements.
Where no national or recognized qualification and certification standards exist, the qualification l
and certification requirements will be specified jointly by y
Holtec's Project Manager and Q.A. Manager.
l Holtec personnel performing special processes must be qualified in accordance with written procedures meeting applicable
- codes, standards and design specifications.
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HOLTEC QUALITS.4SURANCE MANUAL l
NO.
X REV.
4 DATE 12-4-93 PAGE 38 of 63 p
G INSPECTIONS EIRPOSE i
To establish measures to perform inspections of materials and
)
l components in the spirit of 10CFR50 Appendix B, 10CFR71 Subpart H, j
and 10CFR72 Subpart G.
j APPLICABILITY l
l Generally, Holtec does not engage in manufacturing and thus the
)
l provisions of this section apply to Holtec's suppliers who will l
l manufacture equipment on contract from Holtec.
- However, the provisions of this section shall also apply to Holtec in cases where inspection responsibilities are to be performed directly by Holtec.
i POLICY Inspections of materials and components shall be performed in l
accordance with Holtec quality and project inspection procedures.
A supplier's inspection procedure meeting the criteria of this
' Q section and Holtec's overall QA program may be used upon Holtec approval of the procedures and/or supplier's QA program, as determined by the Holtec project team. These procedures shall be established to include requirements for the following:
Performance of inspections; review, concurrence, and approval of inspection results establishment of inspection schedules; and evaluation of results, record preparation and retention requirements.
The procedures for inspections shall also establish requirements to be included in procurement documents for the inspection of supplier performance at hold points during the manufacture of materials and/or ct.mponents for Holtec.
I If the inspection of processed items is impossible or l
disadvantageous in the judgement of the Holtec Q.A. Manager, then indirect control by monitoring of processing methods, equipment and personnel shall be provided in accordance with a written project l
procedure.
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HOLTEC QUALITY ASSURANCE MANUAL NO.
X REV.
1 DATE 2-10-87 PAGE 39 of 63 INSPECTIONS Inspections shall be performed by qualified individuals other than those who performed or directly supervised the activity being
. inspected.
Outside suppliers shall also be required to use independent inspectors.
Evaluation of inspection schedules and results shall be conducted l
by the Quality Assurance Manager to assure that all inspections are carried out and in compliance with the requirements thereto.
Any changes made in the inspection instructions shall be handled in accordance with the requirements of Section VI,
" Document Control," of this Manual.
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HOLTEC QUALITY ASSURANCE MANUAL 1
NO.
XI REV.
3 DATE 12-4-93 PAGE 40 of 63 O
)
TEST CONTROL l
PURPOSE j To establish measures-to provide for testing of materials, j computer codes, components, systems, etc. in a controlled manner l as specified in 10CFR50 Appendix B,
10CFR71 Subpart H,
and l 10CFR72, Subpart G.
I i
APPLICABILITY l The commitments of this section will apply to Holtec's supplier or l Holtec depending on the type and scope of the project.
POLICY O
When testing is required to demonstrate that a
- material, component, or system will perform satisfactorily in
- service, l Holtec or its supplier shall use written and approved procedures l or instructions for such testing. These procedures shall include the following as applicable:
l Necessary test equipment and calibration requirements; material requirements; l
personnel qualification requirements; prerequisite, environmental, and limiting conditions detailed performance instructions for the testing method (including nonconformance control);
O
r HOLTEC QUALITY ASSURANCE MANUAL a
Nn.
XI REV.
1 DATE 2-10-87 PAGE 41 of 63 TEST CONTROL l
inspection hold points; acceptance and rejection criteria l
l detailed instructions for documenting and evaluating test i
results to assure that test requirements have been i
satisfied; and documentation
- approval, retention, and storage i
requirements The Project Manager is responsible for the test programs.
The test programs and procedures are prepared by the engineering staff, and reviewed and approved by the Project Manager and the Quality Assurance Manager.
]
Any changes made in the test procedures shall be handled in l
accordance with the requirements of Section VI, " Document Control,"
of this manual.
l The Quality Assurance Manager is responsible for quality assurance l
review and concurrence with test requirements contained in
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HOLTEC QUALITY ASSURANCE MANUAL A
NO.
XII REV.
2 DATE 9-29-88 PAGE 42 of 63
()
CONTROL OF MEASURING AND TESTING EQUIPMENT I
P.URPOSE j
To establish measures for control of measuring and test equipment used in safety-related projects.
APPLICABILITY l
l In the event a Holtec project requires the use of measuring and test equipment, the commitments of this section will be invoked.
l POLICY The Project Manager is responsible for ensuring that appropriate O
V calibration requirements are included in procurement documents.
l Suppliers may calibrate and inspect their own measuring and testing equipment, or they may use the services of an approved standards laboratory.
The M&TE will be calibrated againt certified equipment having known valid relationship to nationally recognized standards. In all cases, written procedures shall be used for the calibration work, for the control of calibration standards, and for dispositioning discrepant M&TE apparatus.
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HOLTEC QUALITY ASSURANCE MANUAL NO.
XIII REV.
1 DATE 2-10-87 PAGE 43 of 63 HANDLING, STORAGE, AND SHIPPING PURPOSE To establish measures for handling, storage and shipping of safety-related projects, in conformance with ANSI N45.2.2 - 1978.
APPLICABILITY The policy provisions of this section govern handling, storage anil shipping of all safety related
- products, including computer programs.
POLICY O
The Holtec Project Manager shall prepare written instructions for the preservation,
- handling, storage, and shipping of project materials to assure against damage or deterioration of all project items including software, documentation, and records.
Necessary instructions for preservation shall assure that items subject to deterioration or damage through exposure to
- air, moisture, or other environments will be cleaned and preserved during processing and storage by such methods as required to preclude damage.
Items subject to damage shall be packaged in a manner and with such materials as required to prevent damage.
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HOLTEC QUALITY ASSURANCE MANUAL NO.
XIII REV.
1 DATE 2-10-87 PAGE 44 of 63 O
HANDLING, STORAGE AND SHIPPING Requirements for packaging shall consider conditions affecting the item at a supplier's facility, at a project location, in transit to destination, and at the destination.
Where required, packaging shall include means for indicating environments that are critical within the
- package, such as moisture
- content, I
temperature, and gas pressure.
When maintenance of specific internal or external environments is necessary, the means for achieving this condition shall be provided in the packaging, and I
necessary special instructions regarding interior systems or exterior environment shall be provided on the exterior of the packas',
O ror items that re susceveidte to hand 11ns d m se, seecial handling instructions covering fabrication processing, transportation, construction, or installation shall be provided.
Construction and installation sites shall be provided copies of special handling instructions, where appropriate.
For items that are required to be stored, storage instructions shall be provided to ensure against deterioration and damage.
Instructions shall provide for adequate
- safety, maintenance, periodic inspection, and periodic accountability.
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l HOLTEC QUALITY ASSURANCE MANUAL l
NO.
XIII REV.
2 DATE 1-14-91 PAGE 45 of 63 HANDLING, STORAGE AND SHIPPING Shipping instructions shall be provided for inspection and control of all project items transported under Holtec cognizance.
Prior
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to the release for shipment, a final inspection shall be performed
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to ensure the following:
Items are correctly identified as to status of completion of applicable inspections and tests; items are complete and correctly assembled as required, items have been preserved and packaged in accordance with applicable procedures and contract requirements; packaged items have been identified and marked in accordance with applicable procedures and specifica-tions; Cd the packaging and marking of all items comply with appropriate
- ICC, NRC,
- FAA, or postal rules and regulations, as a minimum, and all items shall be readily identifiable at destination; and items shipped shall be accompanied with necessary shipping and technical documents, including appropriate special handling instructions.
l The handling, storage, and shipping requirements outlined above shall be met by Holtec, either directly or through imposition of applicable requirements on the suppliers.
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l HOLTEC QUALITY ASSURANCE MANUAL l
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NO.
XIV REV.
3 DATE 12-4-93 PAGE 46 of 63 INSPECTION AND TEST STATUS PURPOSE To establish measures to control inspection, test and traceability l requirements of procured material and items.
APPLICABILITY l
l The provisions of this section apply to Holtec as well as its j
l suppliers, as applicable.
j l
POLICY All items received that require identification and control shall be identified and controlled in accordance with a
written l
l procedure.
In general, the procedure shall specify that an item i
requiring control and identification shall be positively marked O
ita r 9 ce to tr e ditity r autr at-na uit et-ror== -
In the event the traceability is lost or destroyed, the item shall be considered nonconforming until otherwise identified.
i i
The Quality Assurance Manager shall ensure that a procedure for l
identification and control of materials, parts, and components is l
1 written and implemented.
This procedure shall include appropriate details dealing with the authority and execution of application / removal of tags,
- labels, stamps, etc.
The Quality Assurance Manager shall also audit the implementation of the procedure.
The assigned Project Manager is responsible for ensuring that his personnel follow the identification and control procedures.
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HOLTEC QUALITY ASSURANCE MANUAL NO.
XIV REV.
1 DATE 2-10-87 PAGE 47 of 63 INSPECTION AND TEST STATUS i
All required tests and inspections shall be conducted in accordance with written procedures or instructions.
The instructions shall require sign-off on shop travelers or similar documents to assure that required inspections and tests are performed.
All required documentation shall be maintained in accordance with document control practices.
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HOLTEC QUALITY ASSURANCE MANUAL
'O NO.
XV REV.
3 DATE 8-18-87 PAGE 48 of 63 O
NONCONFORMING MATERIALS, PARTS, OR COMPONENTS l
PURPOSE To establish measures to control materials, parts, or components which do not conform to requirements in order to prevent their inadvertent use or installation.
APPLICABILITY This policy applies to all Holtec activities associated with the identification and control of safety related items, services, or activities which do not conform to technical or quality requirements.
POLICY Procedures shall be established to control nonconforming safety related items, services, and activities.
The procedures shali include provisions for the identification, documentation, review, disposition, and notification of the affected organizations, as appropriate.
I Nont:onforming services or activities shall be reviewed and dispositioned in accordance with documented procedures.
Nonconforming services or activities, including those of suppliers, for which the recommended disposition is " accept-as-en o
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HOLTEC QUALITY ASSURANCE MANUAL n
NO.
XV REV.
3 DATE 12-4-93 PAGE 49 of 63
\\Q NONCONFORMING MATERIALS, PARTS, OR COMPONENTS
(
is" or " repair" shall be submitted to the customer for approval or l
l for information as applicable and as required by customer purchase j orders and other contractual documents. All nonconformance reports dispositioned " accept-as-is" or " repair" shall become part of the records to be submitted with the service, activity, or item.
Any acts of error or omission, either during the execution or post-execution phase of the contract, must be brought to the attention of the Q.A.
Manager.
The Q. A.
Manager will determine whether the reporting should be limited to the customer, or if 10CFR21 reporting is warranted.
A lV Nonconformances shall be controlled in accordance with the Holtec quality assurance procedure, "Nonconformances and Corrective Actions."
This procedure shall describe the basic requirements for identification, reporting, segregation, disposition, and management review of nonconformances.
l It is the responsibility of anyone who detects a nonconformance to l
report it in accordance with the nonconformance procedure.
The procedure describes the specific methods for recording, identifying, and segregating nonconformances, assigning specific responsibility for corrective action, specifying follow-up action to ensure corrective action is taken, and documenting all aspects of the nonconformance, including its disposition (with signature O
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HOLTEC QUALITY ASSURANCE MANUAL NO.
XV REV.
7 DATE 12-4-93 PAGE 50 of 63 O
NONCONFORMING MATERIALS, PARTS, OR COMPONENTS approvals of the disposition).
Measures which control further processing, delivering, or installation of a nonconforming or defective item pending a decision on its disposition shall be established and maintained.
IMPLEMENTATION The Quality Assurance Manager is responsible for ensuring that nonconformances, which are identified by means of quality assurance inspections or audits, are resolved in accordance with nonconformance and audit procedures.
The Project Manager is responsible for ensuring that a
nonconformance detected and reported by a member of his staff is resolved in accordance with nonconformance and audit procedures.
The Project Manager is also responsible for ensuring that procurement documents (specifications) require suppliers to prepare and utilize written procedures for the control of nonconforming items and services, and to notify Holtec of such nonconformance.
All nonconformances that have been corrected by rework or repair must be verified as satisfactory by an inspection of the affected l item to the original requirements or approved deviations and new requirements. This inspection shall be documented.
When a nonconforming item is repaired, it must meet disposition requirements that are approved by the Project Manager and the QA Manager.
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l HOLTEC QUALITY ASSURANCE MANUAL NO.
XV REV.
1 DATE 2-10-87 PAGE 51 of 63 i
NONCONFORMING MATERIALS, PARTS, OR COMPONENTS l
l A description of the change, waiver, or deviation that has been accepted shall be documented to record the change and denote the as-built condition.
The Quality Assurance Manager is responsible for maintaining a file of all nonconformance reports and corrective action reports.
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HOLTEC QUALITY ASSURANCE MANUAL O
NO.
m aEv.
1 oATE 2 2 PAos s2 of
.3 CORRECTIVE ACTION PURPOSE To establish measures to assure that conditions adverse to quality, such as failures, malfunctions, deficiencies, deviations, defective material and equipment, and nonconformances are promptly identified and corrected.
APPLICABILITY This policy applies to all functions performed by Holtec associated with the identification and correction of conditions I
adverse to quality for safety-related
- items, services, or activities.
POLICY j
Conditions adverse to quality shall be promptly identified and corrected in accordance with the applicable change / deviation procedures.
Nonconformances and corrective actions shall be documented.
Nonconformance reports may be initiated by any Holtec person.
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HOLTEC QUALITY ASSURANCE MANUAL NO.
XVI REV.
1 DATE 2-10-87 PAGE 53 of 63 CORRECTIVE ACTION IMPLEMENTATION The basic requirements for controlling nonconformance and performing corrective action shall be documented in the Holtec quality assurance procedure "Nonconformance and Corrective Action."
This procedure includes provisions for the evaluations of nonconformances, the determination of suitable corrective action, the responsibility of or timely disposition and follow-up I
action, and the required corrective action documentation. In the evaluation of a nonconformance, consideration shall be given to l
the causes of the nonconformance and to procedures that would
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prevent its repetition.
k
,q The Project Manager is responsible for stating the requirement, in procurement documents, that suppliers prepare procedures by which nonconformances are promptly identified, corrected, documented, and reported to Holtec.
In addition, the Project Manager is responsible for ensuring that nonconformances identified by his
{
staff are documented and corrected.
The Manager, Quality Assurance, is responsible for ensuring that nonconformances are identified, documented, and corrected.
He is also responsible for the development of procedures for the performance of quality assurance reviews, inspections, and audits.
1 These procedures include provisions for the l
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HOLTEC QUALITY ASSURANCE MANUAL NO.
XVII REV.
1 DATE 2-10-87 PAGE 54 of 63 CORRECTIVE ACTION identification of problems and deficiencies, for ensuring that responsible personnel are notified of nonconformances, and for re-audits or inspections to assure the corrective action and documentation are accomplished.
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HOLTEC QUALITY ASSURANCE MANUAL NO.
XVII REV.
1 DATE 2-10-87 PAGE 55 of 63 QUALITY ASSURANCE RECORDS l
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l PURPOSE I
To provide requirements for the maintenance of sufficient records i
to furnish evidence of activities affecting quality.
i APPLICABILITY i
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l This policy applies to functions performed by Holtec for the generation, control, and maintenance of quality assurance records for safety-related items and services.
POLICY Quality assurance records shall be legible, reproducible, complete and accurate.
Applicable organizations shall prepare sufficient records as their work is performed to provide documentary evidence of activities affecting quality.
Quality assurance records shall include, but are not limited to, design records (such as specifications,
- drawings, procurement documents); results of reviews, inspections, tests, analyses, and l
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HOLTEC QUALITY ASSURANCE MANUAL I
NO.
XVII REV.
3 DATE 12-4-93 PAGE 56 of __61 QUALITY ASSURANCE RECORDS audits; qualification records, nonconformance and corrective acticn reports, and 10CFR21 evaluations.
IMPLEMENTATION l All records designated as Lifetime Quality Assurance Records on a project must be maintained in duplicate storage for the lifetime of the particular item while it is installed in a plant or stored for future use. The records may be kept in microfiche or other compact form to minimize storage space requirements.
For purposes of archival recording, the Project file and the Engineering file are merged into one file called the " Records n
File" and duplicate material is discarded.
The customer may seek custody of certa!n records, in which case documentation indicating such a transfai of custodianship shall be available in the " records file".
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HOLTEC QUALITY ASSURANCE MANUAL NO.
XVIII REV.
1 DATE 2-10-87 PAGE 57 of 63 QUALITY ASSURANCE AUDITS PURPOSE To establish policy for conducting audits which assures that at:
adequate quality assurance program exists and to determine the effectiveness of the program.
APPLICABILITY 1
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This policy applies to internal Holtec audits and audits of I
suppliers.
E.QMG1 The audit program shall proiide for both internal and external audits.
Audits shall be performed by competent personnel not having direct responsibilities in the areas being audited.
Qualification requirements for auditors shall be established and documented, and records of auditor qualifications shall be maintained.
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HOLTEC QUALITY ASSURANCE MANUAL NO.
XVIII REV.
6 DATE 7-17-89 PAGE 58 of 63 QUALITY ASSURANCE AUDITS j
Audit results, including nonconformances, shall be documented.
Deficient areas shall be reviewed or reaudited on a timely basis to verify implementation of corrective action.
IMPLEMENTATION
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The Quality Assurance Program shall include the following essential elements:
audit planning, scheduling, implementation, report of audit findings, and follow-up.
Audits shall be planned, conducted, and documented to assure the effectiveness of the Quality Assurance Program, consistent with the overall coordination of the audit activities.
l Each element of Holtec's Quality Assurance Prcgram shall be audited at least annually.
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HOLTEC QUALITY ASSURANCE MANUAL NO.
XVIII REV.
6 DATE 7-17-89 PAGE 59 of 63 l
v QUALITY ASSURANCE AUDITS Audits shall be performed in accordance with written procedures, using applic e's checklists, by appropriately trained personnel not having direct responsibility in the area being audited.
3 The results of audits shall be reviewed with the responsible personnel of the audit organization during post-audit conferences, and each audit finding on quality shall be documented separately.
In addition, an audit report shall be prepared summarizing the audit.
Audit reports shall be transmitted via the Quality Assurance Manager to responsible personnel at the audited organization for review and implementation of corrective action, when required.
Reports of internal Holtec audits shall be transmitted to the President, Holtec International.
i The audit Team Leader shall be responsible for timely follow-up action (including re-audits),
as
- required, to ensure that corrective action has been taken.
Audit findings shall be documented in the audit report, and all corrective action and re-audits shall be documented with reference to the original audit report.
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HOLTEC QUALITY ASSURANCE MANUAL No.
REV.
2 DATE 2-1-91 PAGE 60 of 63 l
l EXHIBIT A - REVIEW AND CERTIFICATION LOG
]
DOCUMENT NAME:
HOLTEC DOCUMENT I.D. NO.
HOLTEC PROJECT NUMBER CUSTOMER / CLIENT:
REVISION BLOCK QUALITY PROJECT ISSUE AUTHOR REVIEWER ASSURANCE MANAGER NO.
& DATE
& DATE
& DATE
& DATE ORIGINAL ISSUE V
REVISION 1 REVISION 2 REVISION 3 REVISION 4 REVISION 5 REVISION 6
- Must be Project Manager or his Designee.
NOTE:
Signatures and printed names, are required in the review block.
This document conforms to the requirements of the design specification and the applicable sections of the governing codes.
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HOLTEC QUALITY ASSURANCE MANUAL NO.
IX REV.
8 DATE 12-4-93 PAGE _ft1_ of 63 O
APPENDIX A - LIST or QuitIrY PROCEDURES Procedure No.
Title of Procedure 1.0 organization and Responsibilities 2.0 Quality Assurance Program 2.1 Quality Assurance Manual and Procedure Control 2.2 Execution of HQAM and Extension to a Fabricator's Facility 2.3 Quality Forms for Quality Assurance Program Implementation 3.0 Contract Administration and Design Control 3.1 Design Input Requirements 3.2 Design Analys 4 3.3 Design Verifie tion 4.1 Purchase Orde..
5.1 Design Drawings 5.3 Standard and Project Procedures 5.4 Fast-Fax Analysis 6.0 Document Control 6.1 Project Document Transmittal and Control 7.0 Receipt Inspection 7.1 Supplier Selection 7.2 Supplier Surveillance
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7.3-Material Dedication 7.4 Approved Suppliers List 7.5 Material Dedication Procedure (for items not covered by HQP 7.3) l 8.0 Material and Item Identification and Control 9.0 Qualification of Personnel Performing Holtec Special Processes l
9.1 Written Practice for Qualification of NDE personnel l
9.2 Walder Qualification Requirements 9.3 Inspector Qualification for Non-NDE Activities 11.0 Computer Programs 12.0 Equipment Calibration and Control of Measuring and Test Equipment 14.0 Inspection and Test Status 15.1 Reporting of Defects and Noncompliance per 10CFR21 16.0 Non-Conformance and corrective Action 17.0 Quality Assurance Records 18.1 Certification of Audit Personnel l
18.2 Audits l
19.1 Personnel Reliability Program j
19.2 Field Services 19.3 Qualification Requirements and Duties of Registered Professional Engineers for Section III Activities
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HOLTEC QUALITY ASSURANCE MANUAL NO.
APP.B REV.
9 DATE 10-18-94 PAGE 62 of _11_
APPENDIX B - HIGHER BASIS, POLICY AND PROCEDURE MATRIX Higher Criterion Basis Number Element Document HQF No.
I Organization NQA-1 HQP-1.0 II Quality Assurance NQA-1 HQP-2.0 Program HQP-2.1 HQP-2.2 HQP-2.3 l
HQP-2.4 III Design Control N45.2.11 HQP-3.0 NQA-1 HQP-3.1 HQP-3.2
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HQP-3.3 IV Procurement N45.2.13 HQP-4.1 Document Control NQA-1 V
Instructions, NQA-1 HQP-5.1 Procedures HQP-5.3 and Drawings HQP-5.4 VI Document Control NQA-1 HQP-6.0 HQP-6.1 VII Control of N45.2.13 HQP-7.0 Purchased NQA-1 HQP-7.1
- Material, HQP-7.2 i
Equipment, HQP-7.3 and Services HQP-7.4 HQP-7.5 l
HQP-7.6 l
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HOLTEC QUALITY ASSURANCE MANUAL NO.
APP. B REV.
3 DATE 12-4-93 PAGE 63 of _11_
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APPENDIX B - HIGHER BASIS, POLICY AND PROCEDURE MATRIX 1
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Higher l
Criterion Basis Number Element Document HQP No.
I VIII Identification NQA-1 HQP-14.0 and Control of HQP-8.0 Material HQP-7.0 IX Special Processes NQA-1 HQP-9.0 ANSI N45.2.6 HQP 9.1 HQP 9.2 HQP 9.3 X
Inspections NQA-1 HQP-7.0 HQP-14.0 XI Test Control NQA-1 HQP-9.0 HQP-11.0
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XII Control of ANSI N45.2.11 HQP-12.0 Measuring and NQA-1 Test Equipment XIII Handling, Storage ANSI N45.2.2 and Shipping NQA-1 XIV Inspection &
ANSI N45.2.13 HQP-14.0 Test Status-NQA-1 XV Nonconforming NQA-1 HQP-15.1 Materials, HQP-2.3 Parts or components XVI Corrective NQA-1 HQP-16.0 Action XVII Quality Assurance N45.2.9 HQP-17.0
)
l Records NQA-1 XVIII Audits N45.2.12 HQP-18.1 N45.2.23 HQP-18.2 NQA-1
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