ML20029A795
| ML20029A795 | |
| Person / Time | |
|---|---|
| Site: | 07100585 |
| Issue date: | 02/06/1986 |
| From: | Faloon R MQS INSPECTION, INC. (FORMERLY MAGNAFLUX CORP.) |
| To: | |
| Shared Package | |
| ML20029A794 | List: |
| References | |
| NUDOCS 9103040267 | |
| Download: ML20029A795 (51) | |
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APPROVED W
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I QUALITY ASSURANCE PROGRAM l
FOR MQS INSPECTION, INC.
I 33,G.100 The copyright and all other rights to this document are retained by MQS and use thereof in competition with MQS is prohibited.
9103040267 910228 Issue for Use
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WGB 2/6/86 REVISION DESCRIPTION BY DATE
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UNtTf D STATLS NUCLEAR REGULATORY COMMtsslON 4
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ATIN: Mr. W. Blankenship 2301 Arthur Avenue Elk Grove Village, IL 60007 Centlemen:
Enclosed is Quality Assurance Program Approval for Radioactive Material Packages No. 0585, Revision No. O.
Please note the conditions in the approval. Also note, that authorization to receive, possess, and use licensed material is subject to the conditions, of your byproduct material license.
Sincerely, Charles E. MacDonald, Chief Transportation Certification Branch Division of Fuel Cycle and Material Safety, NMSS
Enclosure:
As stated
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NRC FORM 311 n$R$
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ncvmon suuaca FOR RADIOACTIVE MATERIAL PACKAGES 0
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Pursuant to the Atomic Energy Act of 1954,as amended, the Energy Reorganiration Act of 1914 as amended.-and Title 10. Code of Federal l'
Rsgulations, Chapter 1, Part 71, and en reliance on statements and representations heretof ore made in item 5 tsy the person named it,, tem h
2, the Ovality Assurance Program identd.ed in item 5 is hereby approved This approvalis issued to sat: sty the re,quirements of Section I'j 71,101 of 10 CFn Part 71. This approvat is subject to all applicable rules, regulations, and orders of the Nuclear Regulatory Commission i
now or hereaf ter in effect and to any conditions spec,faed besow,
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tnAue 2 ExpinArion oArc HQS Inspection, Inc.
h STREET AconESs March 31,1991 h
[i 2301 Arthur Avenue
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February 17, 1986 F
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- e. conoitions 1, -
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p, Activities authorized by this approval:
procurement', maintenance, h
l repair and use to be executed with regard to transportation packages in h
assembly, testing,,other shipping activities (i.e., design, fabrication, h
special fonn.
All and modification) shall be sati,sfied by~ohtaining g
I certifications from packa'ge. suppliers that these activities were conducted p
in accordance with an NRC a'pproved 0A progran, /It s' hall remain the j
responsibility.of the licensee-user that all transportation activities.
.j meet the reoui rements of 10,C. FR. $71.,101.
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HIEF, TRANSPORTATION CERTIFICATION ORANCH DATE r
)lVtSION OF FUEL CYCLE AND MATEnlAL SAFETY f
)FFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUAROS
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l INTRODUCTION
'Ihe purpose of this program is to address the requirements of any industry requiring an assured quality system and to provide uniform policies for the operatives of MQS Inspection, Inc. The requirements of 10 CFR 50, Appendix B, ANSI NQ A-1 and Mil-Q-9858 have been adapted to the operations of this organiza-tion. A response to each of the 18 criteria of 10 CFR 50, Appendix B, is contained in 33.G.100 (Q A Program) of the manual. 'Ihose considered not applicable have been noted as such and reference any criteria which might be considered as applicable.
MQS Inspection, Inc., provides nondestructive testing and inspection services to many different facets of the industrial and commercial marketplace.
MQS Inspection, Inc., does not manufacture any materials, parts or components.
STATEMENT OF M ANAGEMENT POLICY MQS Inspection Inc., a Delaware Corporation, is headquartered in Elk Grove Village, Illinois. MQS Inspection Inc. operates a third party inspection agency through a nationwide network of inspection facilities.
MQS Inspection, Inc., provides services for performing nondestructive examinations, the development of quality programs, vendor surveillance and other related services. Wese services are provided to a wide variety of clients in all industries. %e MQS Inspection, Inc., Quality Assurance Program was specifically developed for the commerical nuclear industry and is organized in accordance with 10 CFR 50 Appendix B. %e Quality Assurance Program does comply with other specifications and requirements and is applicable to any industry requiring an assured quality system.
Quauty Assurance is recognized as a management function affecting all organiza-tion levels and each individual within the organization. His Quality Assurance Program establishes a uniform program for MQS Inspection, Inc., and willbe adhered to on all activities requiring a Quality Assurance Program.
De Director of Quality Assurance reports directly to the President of MQS Inspection, Inc. We Director of Quality Assurance, by organizational arrangement, has no responsibility for production costs or schedules. He is responsible for establishing, implementing and maintaining the Quality Assurance Program. nis responsibility extends to all activities performed by or for MQS Inspection, Inc.
All personnel assigned to operations subject to the requirements of this program shall be indoctrinated to the requirements, policies, and objectives set forth herein.
%cy shallbe responsible for executing those policies, explicit or implied, pertinent to their assignments.
[NN Date A0 Presipeh
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MQS INSPECTION, INC.
1.0 QUALITY ASSUR ANCE PROGR AM 1.1 Applicability 1.1.1 MQS Inspection, Inc., hereafter referred to as the Company, defines, establishes and implements by means of this Quality Assurance Pro-gram a formal and comprehensive system to assure that the quality of all services or products furnished to clients conforms to specified contractual requirements.
1.1.2 All laboratories and projects designated by the Company shall operate in accordance with the appilcable quality assurance policies and requirements stated herein.
1.1.3 This Quality Assurance Program is developed in response to the re-quirements or criteria of:
(a)
Title 10, Code of Federal Regulations, Part 50, Appendix B (b)
Title 10, Code of Federal Regulations, Part 21 (c)
Title 10, Code of Federal Regulations, Part 71 and Regulatory Guide 7.10.
(d)
American Society of Mechanical Engineers, Boiler and Pressure Vessel Code (e)
American National Standards Instituto N45.2 - 1971 - 1977 (f)
American National Standards Instituto NQ A-1-1979 including all Addenda through NQ A-1c-1982 (g)
American National Standards Instituto NQ A-1-1983 Edition including Addenda NQ A-la-1983 (h)
Military Specification MIIrQ-9858A and MIIrl-45208 A (1)
American Petroleum Instituto Specification Q1 (j)
'Ihe Company Statement of Policy 1.2 Program Documentation Administrative Procedures are developed and implemented to control all activities affecting quality to an extent consistent with their importance.
These procedures include the duties, responsibilities, and organizationallevel of those persons charged with the establish-ment and enforcement of the quality requirements. Quality functions for all facilities are described by documents outlined below.
1 of 38 QUAL!TY ASSUR ANCE PROGR AM 33.G 100
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A.
Quality Assurance Documents 1.
%e QA Program is a generic document. It states the Company quality policies and intents with regi.d to refer-enced code standards, 2.
He administrative procedures address the specific quality requirements of the QA Program. Wey provide the work-ing instructions for implementing the Q A Program.
B.
Quality Control Documents 1.
Test & Inspection Procedures (TIP's) are the detailed work instructions for conducted testing, inspection or examina-tion of materials, parts or components.
2.
Instructions & drawings detail design criteria and code, specification and client requirements.
1.3 Control of Quality Assurance Documents 1.3.1 he Director of Quality Assurance (QA) is responsible for the control of the Quality Assurance dwuments. IIe will determine those fune-tions within the Company performing activities affecting quality, and provide controlled copies of these documents to appropriate person-nel.
l 1.3.2 All controlled copies of these documents will be individually num-bored for control purposes and a record of each controlled document holder maintained. Should the holder's requirements for a document cease, he shall promptly return his copy to the issuing authority.
1.3.3 It is the responsibility of each holder of Q. A. documents to keep his copy current and to enter all revisions.
Controlled copics of the Quality Assurance documents may not be used by others outside of the Company except with the permission of the Director of Q A and with written agreement that the documents will not be rep oduced, copied or used in whole or in part except as permitted.
1.3.4 Copies for general information shall be issued as " uncontrolled" copies. He holder shall be responsible for verifying that the con-tents of an uncontrolled copy is current prior to use.
1.4 Periodic Program Review l
Periodic review of the Quality Assurance Program will be conducted j
on an annual basis by executive management, the Director of Q A and the Quality Control (QC) Managers. %ey shall review the adequacy, 2 of 38 QUAIEIT ASSURhNCE PROGRAM 33.G.100
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completeness and effectiveness of the program, document such reviews and recommend changes in the program.
1.5 Client Access
%e client shall have access to Company documentation as required to assure conformance to all contractual requirements.
1.6 Quality Assurance Indoctrination and Training 1.6.1 he Director of QA shall be responelhk, for directing the indoctrina-tion and training of all personnel assigned to o, arations subject to the requirements of this program.
1.6.2 he QA indoctrination and training of personnel who monitor com-pliance to this program will be conducted by the Director of Q A or the Managc? of QC.
%e indoctrination and training of other employees shall be conducted by the QC Monitor. 'lhe indoctrination may be accomplished either individually or as a group.
1.6.3 he purpose of the Q A indoctrination and training program is to fam-illarize employees with the Quality Assurance Program stressing the importance and meaning of Quality Assurance / Quality Control as it applies to the employee's position.
%c following items will be covered in the training program.
(a)
Objectives of the Quality Assurance Program (b)
Quality Assurance organization and how it affects the duties and responsibilities of the employee (c)
Contents of the Quality Assurance and Quality Control docu-ments with specific emphasis placed on those sections which most directly affect the employee's position.
1.A.4 A record of attendance at a quality assurance indoctrination lecture willbe maintained for each employee required to attend.
1.7 Controlled Conditions All activities affecting quality shall be accomplished under suitably controlled conditions.
Conditions include the use of appropriate equipment; suitable environmental conditions for accomplishing the activity and assurance that all prerequisites for the given activity have been satisfied. These requirements shall be covered in detailin the Test and Inspection Procedure.
1.8 Special Skills, Processes and Equipment 3 of 38 QUALITY ASSURANCE PROGRAM 33.G.100 I
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His program _ takes into account the need for special controls, pro-cesses, test egulpment, tools and skills to attain the required quality and the need for verification of quality by inspection and test.
1.9 Quality Terms and Definitions i
A glossary of commonly used terms and definitions found in the Quality Assurance Manualis found in Appendix 1.
2.0 ORGANIZATION AND PLANNING j
q 2.1
%e Quality Organization 2.1.1
%e MQS President is the chief operating officer. Each facility is charged by the President with the responsibility for assuring that all tests, inspections, examinations, services and operations performed 1
will conform to contractual requirements.
I 2.1.2 De President-has structured.the quality organization such that its function is not influenced by operations or production and timt the management and direction of the Director of Q A is his responsibility.'
- Re Director of QA reports directly to the Executive Vice President and interfaces _with facility managers. (See Figure 2-1) 2.1.3 We Director of Quality' Assurance (QA) is appointed by the President
'and is responsible for directing the development and implementation of the Quality Assurance Program and the surveillance and auditing of the QA Program. He reports to the Executive Vice President for
-management and administrative guidance. He is also responsible for -
-(a) directing. the preparation of amendments or revisions to the-Quality Assurance Program;-
(b) directing the preparation and implementation of administrative procedures for facilities;
-(c); -directing the preparation of %st & Inspection Procedures; (d)1 performing and directing scheduled monitoring and surveillance -
of the quality program at au facilities; 1
(e) initiating or directing actions which result in solutions to qual-ity problems and verifying results; (f) determining and issuing stop-work directions; (g) revicwingl the-' QA program _and reporting the status _to,the President 4 of 38 QUALITY ASSURANCE PROGRAM 33.G.100 -
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(h) qualification and certification of auditors.
2.1.4
%e Quality Control (QC) Managers are appointed by the Director of Q A for the purpose of administering the requirements of the Quality Assurance Program. The QC Managers are responsible for the imple-mentation and surveillance of the Quality Control requirements for their assigned facilities. %ey report directly to the Director of Q A on matters relating to quality. %cy are also responsible for (a) approval and implementation of Test & Inspection Procedures, and all amendments or revisions to these Procedures; (b) directing and monitoring of personnel qualifications and certifi-cations; (c) providing assistance to the Director of Q A in the auditing and inspection of facilities; (d) determining and issuing stop-work directions with concurrence of the Director of Q A; (c) the establishment of a Quality Control Review Board. (See Paragraph 2.1.4.1)
(f) reviewing instructions and drawings for verification of quality requirements.
2.1.4.1 he Quality Control Managers will establish a Quality Control Review Board composed of management, supervisory and selected personnel with the necessary training and experience capabilities to review and comment on procedural development. We Board will be
. established as deemed necessary by the QC Manager.
2.1.5
%e Document Control Manager is appointed by the Director of Q A and reports directly to the Director of Q A on matters relating to quality. Ile is responsible for (a) preparation of amendments or revision to the Quality Assurance Program; (b) preparation of administrative procedures; (c) development and preparation of Test and Inspection Procedures and amendments or revisions to these procedures; (d) controlof all documents issued by the Q A/QC facility; (c) maintaining records of personnel qualifications and certifica-tions.
5 of 38 QUALITY ASSURANCE PROGit AM 33.G 100
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2.1.6 A Quality Control Monitor is appointed by the Manager of QC or Fmplementation and surveillance of the quauty program.irector of Q A for each facility Vicy are responsibic for:
(a) development of procedure emendments to fit specific require-ments; (b) performing quality control inspections of facility operations under direction of the Manager of QC, and reporting status to the facility manager; (c) assisting with or performing audits under direction of the Director of Q A or the Manager of QC; (d) reporting quality problems to the Director of QA or Manager of 3
QC; (c) determinthg and issuing stop-work directions with concurrence of the QA Director.
2.1.6.1 Each QC Monitor shall be required to pass a written examination administered by the Director of Q A.
2.1.7 All auditors shall be qualified and certified in accordance with written procedures. Audit assignments shall be made by the Director of Q A.
Auditors shall report directly to the Director of QA.
Auditors shall be responsible fort (a) performing scheduled audits of MQS facilities; (b) reporting audit results to the Director of QAt l
1 (c) determining and issuing stop-work directions with concurrence of the Director of QA.
2.1.8 Die individual (s) or organization (s) responsible for implementing the QA Program may delegate any or all of the work to others but shall retain responsibility therefore.
6 of 38 QUALITY ASSURANCE PROGRAM 33.04100
MQS INSPECTION, INC, Figure 2 MQ5 INSPECTION, INC.
ORCANilATIONAL CHART MOS PRESIDENT
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QUALITY ASSURANCE PROGRAM 33.G.100
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3.0 DESIGN CONTROL 3.1 Appilcability
%e requirements for addressing Design Control are not applicEble to the services offered by the Company in that the Company does not design any Safety Related components. Rose elements which may be interpreted to apply, i.e., procedures and instructions, inclusions of quality standards, control of deviations, review of material and processes, and control of documents are addressed in subsequtnt paragraphs of this program.
3.2 References Element Reference (a) procedures & instructions Instructions, Procedures &
Drawings Section 5.0 (b) quality standards & procedures Document Control Section 6.0 (c) control of deviations Test Control Section 11.0 (d) review of materials & processes identification and Control of Materials, Parts & Com-ponents Section 8.0 (e) control of documents Instructions, Procedures &
Drawings Section 5.0 Document Control Section 6.0 4.0 PROCUREMENT DOCUMENT CONTROL 4.1 Aglicability he control of procurement documents applies only to those items which are designated as controlled. Controlled items consist of items of equipment or materials which have calibration, performance or conformance characteristics established by a code, standard, or this program. %ese items are recognized as having quality requirements and a. accord of purchase shall be maintained.
4.2 Responsib!yg 9 of 38 QUALITY ASSURANCE PROGRAM 33.G.100
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3e Manager of a facility is responsible for final approval of procure-monts or the delegation of that authority. All delegations of author-1 ity shall be made in writing. Verification of quality requirements shall be the responsibility of the QC Monitor assigned to the cogni-zant facility.
4.3 Content of Procurement Documents Applicable design bases and other requirements necessary to assure adequate quality shall be included or referenced in documents for pwourement of materials, items and services. Procurement docu-i ments issued at all tbrs of procurement shall include provisions for the following, as deemed necimiary by the Manager of the facility requesting the purchase.
4.3.1 A statement of the scope of the work to be performed by the Supplier shall be in the procurement documents.
4.3.2 Technical requirements shall be specified in the procurement decu-I ments. Where necessary, these requirements shall be specified by I
reference to specific drawings, specifications, codes, standards, reg-I ulations, procedures, or instructions, including revisions thereto that describe the items or services to be furnished. We procurement documents shall provide for identification of test, inspection, and l
acceptance requirements of the Purchaser for monitoring and eval-uating the Supplier's performance.
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4.3.3 Procurement documents shall requhe that the Supplier have a docu-j mented quality assurance program that implements portions or all of l
the requirements of this Program. %e extent of the program re-J quired shall depend upon the type and use of the item or service being procured. We procurement dacuments shall require the Supplier to incorporate appropriate quality assurance program requirements in l
subtier procurement documents.
l 4.3.4 At each tier of a procurement, as applicable, the procurement docu-ments shall provide for access to the Supplier's plant facilities and records for inspection or audit by the Purchaser, his designated rep-resentative, and/or other parties authorized by the Purchaser.
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4.3.5
%e procurement documents at all tiers shallidentify the documenta-l tion required to be ::ubmitted for information, review, or approval by i
the Purchaser. We time of submittal shall also be established. When j
the Purchaser requires the Supplier to maintain specific quality l
assurance records, the retention times and Cisposition requirements j
shall be prescribed.
1 4.3.6 De procurement documents shall include Purchaser's requirements I
for reporting and approving disposition of nonconformances.
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I 4.4 Procurement Document Review 4.4.1 A review of the procurement documents and changes thereto shall be made to assure that documents transmitted to the prospective Supplier (s) include appropriate provisions to assure that items or services will meet the specified requirements.
4.4.2 Reviews shall be performed and documented to provide e5jective evidence of satisfactory accomplishment of such review prior to contract award.
4.4.3 Changes made as a result of the bid evaluations or precontract nego-tlations shall be incorporated into the procurement documents. 'Ihe a
review of such changes and their effects shall be completed prior to contract award. 'Dils review sball include the following considera-tions:
a) appropriate requirements speelflod in 4.0 of this Program; b) determination of any additional or modified design criteria; c) analysis of exceptions or changes requested or speelfled by the Supplier and determination of the effects such changes muy have on the intent of the procurement documents or quality of the item or service to be furnished.
4.4.4 Reviews required by this Section shallbe performed by personnel who 1
have access to pertinent information and who have an adequate understanding of the requirements and intent of the procurement documents.
4.5 Controlof Changes Procurement document changes shall be subject to the same degree of control as utilized in the preparation of the original documents.
4.6 Procurement Records Procurement documents may be issued to a supplier for each procure-ment or may be issued as a standing order against which procure-ments shall be made. All procurement transactions shall be recorded and these records shall be maintained as nonpermanent records.
Copies of procurement documents issued to a supplier shall be main-tained until all items listed on the document have been accepted in accordance with 7.9.
5.0 INSTRUCTION
S. PROCEDURE
S AND DRAWINGS 11 of 38 QUALITY ASSURANCE PROGRAM 33.G.100
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5.1 Appilcability All activities affecting quality shall be prescribed by documented instructions, procedures, or drawings of a type appropriate to the circumstances and shall be accomplished in accordance with these documents. For the purpose of this program, instructions, procedures and drawings shall be divided into three categories:
a)
Instructions and Drawings-These documents describe design cri-teria and code, specification and client requirements; b)
Test and Inspection Procedures-hese procedures provide the specific step-by-step instructions for performing and document-ing the results of tests, inspections, examinations, or quality activities. Rese procedures shall conform to the requirements of a code, standard or client.
c)
Administrative Procedures-These procedures are developed to direct and document the implementation of the QA Program.
Rey provide information describing authority, responsibility and documentation of quality activities.
5.2 Responsibility 5.2.1
%e development of instructions and drawings is considered a man-agement function and shall be the responsibility of the facility man-ager. Verification of quality requirements shall be the responsibility of the QC Monitor assigned to the facility performing activities in accordance with clienth instructions and drawings.
5.2.2 he development of test and inspection procedures and their subse-quent revisions or amendments is the responsibility of the QC Manager or those labon. tory personnel designated by a facility manager to comply with client request.
5.2.3
%e Director of QA shall be responsible for the development and implementation of all administrative procedures.
5.2.4
%e duties of developing and implementing these documents may be delegated to other personnel or facilities provided the responsibility is maintained as outilned.
5.3 Content Reautrements 5.3.1 he documents described herein shall assure that all work affecting quality (including such things as purchasing, handling, machining, assembling, fabricating, inspection, testing, modifications and any other treatment of products, facilities, standards or equipment from 12 of 38 QUAllTY ASSURANCE PROGRAM 33.G.100
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ordering of materlab to dispatch of shipments) shnll be prescribled in clear and conipleted documented instructions of a type appropriate to the circumstances.
5.3.2 Instructions, procedures or drawings shall include or reference appro-priate quantitative and qualitative criteria for determining that pre-scribed activities have been satisfactorily accomplished.
5.3.3 Procedures may either be single element procedures (i.e., one proce-dure - one test) or of a generic nature la general procedure, covering several individual operations, which references a code or standard for each individual element).
5.4 Compliance 5.4.1 All characteristics required to be reported by the material specifica-tions, client and this program shall appear on checklists and each such characteristic shall be examined by accepted procedures as required and the results recorded. Characteristics included in Certi-fled Material Test Reports or Certificates of Compliance need not be dupilcated in the checklists. Checklists shcIl provide for a record that the Certified Material Test Reports and Certificates of Com-pliance have been received, reviewed and found acceptable.
5.4.2 Receiving, in-process and final examinations and test shall be esta-blished to assure conformance with specifications, drawings, instruc-tions, and procedures. Examinations and tests shall be performed in accordance with written procedures which incorporate or reference the requirements and acceptance limits contained la appilcable docu-monts. When the results of an examination or test conducted by the Company are necessary to show compilance with material specifica-tion or other requirements, the checklists shall show the required range of values.
5.4.3 Measures shall be established so that the status and results of any required examinations and tests can be determined for any unterial or product at any time.
5.4.4 A comprehensive system of planned and periodic internal audits shall be carried out by the Company to assure compliance with the Quality Assurance Program.
6.0 DOCUMENT CONTROL 6.1 Applicability
'Ihe preparation, issue and change of documents that specify quality -
requirements or prescribe activities affecting quality shall be con-13 of 38 QUALITY ASSURANCE PROGItAM 33.O.100
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trolled to assure that correct documents are being employed and that obsolete documents and change requirements are removed from all points of issue and use. Documents which are controlled in eccor-dance with this section shan include instructions, procedurcs, draw-ings, Q A Program and changes therete.
6.2 Responsibility 3.2.1 Procedures developed and implemented for document control shall assure that the latest applicable documents, imluding changes, are reviewed for adequacy and approved for releaso by authorized per-sonnel and distributed for use at the loculon where the proscribed activity is performed.
i 6.2.2 Changes to documents shaU be reviewed and r,pproved by the same organizations that performed the original review and approva! unless the facility manager designates another responsible organization.
The reviewing organizations shall have access to pertinent back-3 ground information upon which to base its approval and shall hav(
adequate understanding of the requirements and intent af the original document.
6.3 Document Preparation, Approval and Issue 6.3.1 Documents shall be controlled to assure that correct and applicable documents are available and used at the location where the pro-scribed activity is performed. 'Ihe controls shall be documented.
fi.3.2 Document control procedures shall provide for (a) through (d) below:
(a) identification of documents to be controlled; (b) identification of personnel, positions, or organizations respon-sible for preparing, reviewing, approving and issuing documents; (c) review of documents for adequacy, completeness, and correct-ness prior to approval and issuance; -
(d) documentation method to be employed tc assure compliance with this program.
k 6.4 Document Changes 6.4.1 Changes to documents, other than those defined as minor changes in 6.4.2, are considered as major changes and shall be revjewed and approved as required by 6.2.2.
6.4.2 Minor changes to documents, such as incensequential editorial cor-rections, shall not require that the re /ised documents receive the 14 of 38 QUALITY ASSURANCE PROGRAM
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!Nme l edew mi noroval as the ori inal docum.mts. To avoid a b
possMe omissloa # n iequired review, the type of minor changes tha do NA repire Meh a review and approval and the persons who can nuthotize such a Mehlon shall be clearly delineated in the docu-ment control produn.
6.4.3 Changes to the Quality Assurance Program requested by ellents shall be by written request to the Quality Assurance manager. Changes requested by clients to administrative procudures or TIP's may be completed locally and submltted to the ollrnt providing the Quality Assurann Manager or Quality Control Manager is notifled of the changes.
6.4.4 All changes are subject to corporate approval.
6.5 Subm.it,tal t
6.5.1
' Die Quality Assurance Program may be mbmit'ted with bid proposals.
Administertive procedures and example TIP% w!S ?N Subini'.ted if specifleally requwei by the prospective client. C"strohed copics shall be submitted c)t 'y as requested.
6.5.2 Controlled copies of the Quality Assu7ance Program are cubmitteo to clients after a contraet award if requested. Administrative proco-dures and TIP's will be submitted if specifically requested by the client.
6.6
[groval Written nppeoval for the Quality Assurarx? "regram or its component parts il requested of all clients requesting documents for approval.
7.0 CCNiitOL OF PURCHASED M ATE 111 ALS, EQUIPMENT AND EEIWi&
7.1 Apnlicability
'the services and products omrod by the O)mpany are of such a nature that the equipmmit, and materials usad are mass produced.
Asurance that it. erns confiorm to procuremeat documents is accom-pushed through recidving inspection. Equipem.nt oc materials which are controDed are ehnckd'ior conformame to the code, standard, or requirements speelffed on the proovremont docamente 7,2 RJfge,nsibility 7.2.1
'nte qC Monitor responsible for racciving inspection shall verify that an purphused materials, equiptrent and services meet quality require-ments.
1ToTT~~~QD AIATTI53Mt AN 6E PitOG R AM 33.G.100
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7.2.2 Ver'fication activities, when required to evaluate a supplier's perfor-man shall be accomplished by quellfied personnel netsigned to cheche, inspect, audit or witness the activitics of suppl.lers.
7.3 Procurement Planning n
7.3.1 Procurement activities shall be planned and documented to assure a systematic approach to the procurement process. Procurement plan-ning shall result in the documented identification of procurement methods and orgenizational responsibilities.
7.3.2 Planning shall be accomplished as early as practicable, and no later thon at the start of those procurement activities which are required to be controlled, to assure interface compatibility and a uniform approach to the procurement process.
7.3.3 Planning shall result in the documented identification of metho@ to be used in procurement activities, sequence of actions and milestones indicating the completion of these activities, and the preparation of appilcable procedures prior to the initlation of each individual act.v-ity listed below.
Planning shall provide for the integration of (a) through (h) belows (a) procurement document preparation, review and change control; (b) selection of procurement sourec3; (c)
Purchaser control of Supplier performance)
(d) verification (surveillance, inspection, or audit) activities by Purchaser, including notification for hold and witness points; 4
(e) controlof nonconformances; (f) corrective actions; (g) acceptance of item or service; 3
(h) quality assurance records.
7.4 gplier Selection 7 A.1
'Ihe selection of Suppliers shall be based on evaluation of their capa-bill $ to provide items or services in accordance with the require-monts of the precurement docums:nts prior to award of contract.
7.4.2 Procurement source evaluation and selection procedures shall be implemented by the Purchaser and shall provide for identification of 16 of 38 QU ALITY ASSUltANCE PilOGItAM 33.0.100
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the Purchaser % organizational responsibilities for determining Supplier enpability.
7.4.3 Procedures for evaluation and selection of procurement sources, and the documentation of results therefrom, shall be developed and shcIl include one or more of (a) through (c) belows (a) evaluation of the Supp11 erb history of providing an identical or similar product which performs r.atisfactorily in actual use.
The Supp11 erb history shall reflect current capabilityl (b) review of the Supplier % current quality records supported by documented qualitative and q"antitative Information which can be objectively evaluated:
(c) evaluation of the Supplier % technical and quality capability as determined by a direct evaluation of his facilitics and personnel and the implementation of his quality assurance program.
7.5 Extent of Activities 1ho extent of verification activitics, including planning, shall be function of the rotative importance, complexity, and quantity of the item or services procured and the Supplier % quality performance.
7.6 Records Activities performed to verify conformance to requirements of pro-curement documents shall be recorded.
Sourco surveillancos and inspections, audits, receiving inspections, nonconformances, disoost-tions, walvers, and corrective actions shcIl be documented.
The QC Manager shall assure that this documentation is ovaluated to detumine the Supplier's quality assurance program effectivenena.
7.7 Control of Sufpiler Generated Documents Suppiler genented documents shall be controlled, handled, and approved in no nedance with estabilshed procedures. Means shall be implemented ec assure that the submittal of these documents is accomplished in accordance with the procuremen' document require-monts. These measures shall provido for the acquisition, pwnssing, and recorded evaluation of technical, inspection, and test data against acceptcnce criteria.
7.8 Control of Changes in items or Services 1ho Purchaser and Supplier shall assure that measures to control changes in procurement documents are established, implemented, and 17 of 38 QUALITY ASSUR ANCE PitOGRAM 33.0.100
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documented and are in accordance with this Program.
7.9 Acceptance of item or Service 7.9.1 Methods shall be estabitsbed for the acceptance of an item or service being furnished by the Supplier. Prior to offering the item or service for acceptance, the Suppiler shall verify that the item or service being furnished compiles with the procurement requirements. Where required by code, regulation, or contract requirement, documentary evidence that items conform to procurement documents shall be available prior to installation or use.
7.9.2 1he methods used to accept an item or related service from a Supplier shall be source verification, receiving inspection, Supplier Certificate of Conformance, post-installation test, or a combination thereof.
7.9.2.1 When source verification is used, it shall be performed at intervals consistent with the importance and complexity of the item or ser-vice, and it shall be implemented to monitor, witness, or observe activites. Similarly, tource inspection shall be impicmented in accor-dance with plans to perform inspections, examinations, or tests at prcdotermined points. Upon Purchaser acceptance of source veri-fication, documented evidenca of acceptance shall be furnished to the receiving destination of the item, to the Purchaser, and to the Suppiler.
7.9.2.2 When rocciving inspection is used, purchased items shall be inspected as necessary to verify conformance to specified requirements, taking into account source verification and audit activities and the demon-(
strated quality performance of the Supplier.
Receiving inspection i
shall be performed in accordance with established procedures and inspection instruction, to verify by objective evidence such features as proper configuration; identification; dimensional, physical, and other characteristics; freedom from shipping damrge; and cleanness.
Receiving inspection shall be coordinated with review of Supplier documentation when procurement documents require such document-ation to be furnished prior to rocciving inspection.
7.93. '
When post-installation testing is used, post-Installation test require-ments and acceptance documentation shallbe mutually established by the Purchaser and Suppiler.
7.9.3 Acceptance of Services Only. In certain cases involving procurement of services only, such as third party inspection; engineering and con-sulting services; and installation, repair, overhaul, or maintenance work, tha Purchaser shall accept the service by any or all of the fol-lowing methods:
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(a) technical verification of data produced; (b) surveillance and/or audit of the activity; (c) review of objective evidence for conformance to the procure-ment document requirements such as certifications, stress reports, etc.
7.10 Control of Supplier Nonconformances Procedures shall be developed to establish and document methods for disposition of items and services that do not meet procurement docu-ment regulrements. 'Ihese procedures shall contain provision for (a) through (c) below:
(a)
Evaluation of nonconforming items.
g (b)
Submittal of nonconformance notice to Purchaser by Supplier as directed by the Purchaser.
'Ihese submittals shall include f
Supplier-recommended disposition (e.g., use-ns-is or repair) and g
technical justification. Nonconformances to the procurement g
requirements or Purchaser-opproved documents which consist Jf of one oc more of the following shall be submitted to the Pur-chaser for approval of the recom'.anded dispositions (1) technical or material requirement is violated; (2) requirement in Supplier documents, which has been approved by the Purchaser, is violated; (3) nonconformance cannot be corrected by continuation of the original manufacturing process or by reworki (4) the item does not conform to the original requirement even though the item can be restored to a condition such that the capability cf the item to function is unimpaired.
(c)
Purchaser disposition of Supplier recommendation.
(d)
Vorification of the implementation of the disposition.
(c)
Maintenance of records of Supplier-submitted nonconfor-mances.
8.0 IDENTIFICATION AND CONTROL OF M ATERI AI. P ARTS AND COM PON ENTS 8.1 Applicability 19 of 38 QU ALITY ASSUR ANCE PltOGR AM 33.G.100 l
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Procedures shall be developed and implemented for controlling and identifying material, parts and components, including pat *tially fabri-cated assemblics throughout the examination process and during ship-ment.
8.2 Responsibility Each individual involved in the examination process, including receiv-ing inspection and shipping, shall be responsible for assuring trace-ab!11ty of all items and material under his control. The QC Monitor shall monitor all operations to assure compilance with this require-ment.
8.3 Identification Methods 8.3.1 Procedures developed for identification and control of material and items shall assure that identification is maintained either on the material or item or on records traceable to the material or item throughout examination and shipment of the item. These measures shall be designed to prevent the use of incorrect or defootive mater-lals, parts and components and those which have not received the required examinations, tests or inspections.
8.3.2 Items of production (batch, lot, component, part) shall be identified f om the initial roccipt of the items up to and including shipping.
This identification shall relate an item to an applicable design or other pertinent specifying document.
8.3.3 Material awaiting testing must be separately identified or segregated from already tested and approved material.
Material tested and approved shall be kept identified until such time as its identity is necessarily obliterated by processing. Controls will be established to prevent the inedvertent use of material falling to pass tests.
8.3.4 Physical identification shall be used to the maximum extent possible.
Where physical identification on the item is either impractical or insufficient, physical separation, procedural control, or other appro-priate means shall be employed.
8.3.5 Identification markings, when used, shall be applied using materials and methods which provide a clear and legible identification and do not detrimentally affect the function or servlee life of the item.
Markings shallbe transferred to each part of an identified item when subdivided and shall not be obilterated or hidden by surface treat-ment or coatings unless other means of identification are substituted.
8.4 Specific Requirements 9
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8.4.1 When specified by codes, standards, or specifications that include soccific identification or traceability requirements (such as identi-fication or traceability of the item to applicable specification and grado of material; heat, batch, lot, part, or serial number; or spec-ified inspection, test, or other records) the program shall be designed to provide such identification and traceability control.
8.4.2 Where specified, items having limited calendar or operating Ilfe cycles shall be identified and controlled to preclude use of items whose shelf Ilfe or operating life has expired.
8.4.3 Provisions shall be made for the control of item identification con-sistent with the planned duration and conditions of storage, such ass (1) provisions for maintenance or replacement of markings and identification records due to damage during handling or aging; (2) protection of identifications on items subject to excessive det-crioration due to environmental exposure;-
(3) provisions for updating existing plant records.
9.0 CONTROL OF SPECIAL PROCESSES 9.1 Appilcab(11ty Special processes of the Company are defined as examination including nondestructive exar=8 nations.
9.2 Responsibility All special processes that control or verify quality, shall be performed by qualified personnel using qualified procedures in accor-dance with specified requirements, it is the responsibility of the facility performing the special process to adhere to the approved procedures and processes.
9.3 Process Control Processes shall be controlled by instructions, procedures, drawings, checklists, travelers, or other appropriate means. 'Ihese means shall assure that process parameters are controlled and that specified environmental conditions are maintained.
9.4 Special Processes Each special process shall be performed in accordance with appro-priate instructions which include or reference procedure, personnel, and equipment qualification requirements.
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4 0.4.1 Qualification of personnel, procedures, and equipment shall comply with specified requirements.
9.4.2 Conditions necessary for accomplishment of the process shall be included in procedures or instructions. These conditions shall include proper equipment, controlled parameters of the process, and calibra-tion requirements.
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9.4.3 De requirements of applicable codes and standards, including accep-tance criteria for the process, shall be specified or referenced in the procedures or instructions.
9.4.4 Records shall be maintained as appropriate for the currently qualified personnel, processes, and equipment of each special process.
9.4.5 For special processes not covered by existing codes and standards or g
where quality requirements specified for an item exceed those of
(
existing codes or standards, the necessary requirements for qualifica-tions of personnel, proceduras, or equipment shall be specified or referenced in the procedures or instructions.
10.0 INSPECTION (QUALITY CONTROL) 10.1 Applicability The quality level of operations is maintained by utilizing an internal inspection system.
Inspections are conducted on personnel and processes (procedures) to verify the compliance to procedures, codes, specifications or quality requirements contained in applicable design documents.
All inspections required to verify conformance of an item or activity to specified requirements shall be planned and executed.
10.2 Responsibility
~
%e insp(ection of operations is conducted by the Quality Control 10.2.1 Monitor see figure 2-1) at the laboratory or project location. These individuals are independent of production activity during any inspec-tion of operations.
10.2.2 Additional individuals may be utilized to conduct inspections when necessary providing they are independent of any production responsi-bility at the time of the inspections.
10.2.3
%e Director of Quality Assurance or Manager of Quality Control
~
may include process or personnel inspection in his audit activities (see 18.0).
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10.3 Inspection iloid Points if mandatory inspection hold points are required beyond which work shall not proceed without the specific consent of the ellent's desig-noted representative, the speelfic hold points shall be indicated in appropriate documents. Consent to waive speelflod hold points shall be recorded prior to continuation of work beyond the designated hold point.
10.4 Inspection Planning 10.4.1 Planning for inspection activities shall be accomplished and docu-mented. The documentation shall Identify characteristics, methods, and acceptance criteria, and shall provide for recording objective evidence of inspection results.
10.4.2 Where a sample is used to verify acceptability of a group of items, the sampling procedure shall be based on recognized standard prac-tices.
10.5 In-proecss Inspection 10.5.1 Inspection of items in-proecss shan be performed for work activities where necessary to verify quality. If inspection of processed items is impossible or disadvantageous, indirect control by monitoring of pro-cessing methods, equipment, and personnel shall be provided. Both inspection and process monitoring shan be provided when control is inadequate without both.
10.5.2 A combination of inspection and process maaltoring methods, when used, shall be performed in a systematic manner to assure that the speelfled requirements for control of the process and quality of the item are being ach'aved throughout the duration of the process.
10.5.3 Controls, where required, shall be established and documented for the coonlination and sequencing of these activities at established inspec-tion points during successive stages of the production process or fab-rication.
10.6 Final Inspection 10.6.1 Final inspections shall include a records review of the results and resolution of nonconformances identified by prior inspections. 'lhe final inspection shall be planned to arrive at a conclusion regarding conformance to speelfled requirements.
10.6.2 Completed items shall be inspected for completeness, markings, call-bration, adjustments, protection from damage, or other characterls-l 23 of 38 QU ALITY ASSUR ANCE PROGRAM 33.G.100 l
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ties as required to verify the quality and conformances of the item to specified requirements. Quality records shall be examined for ade-quacy and completenens if not previously so examined.
10.6.3 The acceptance of the item shall be documented and approved by authorized personnel.
10.6.4 Modifications, repairs, or replacements of items performed subse-quent to final inspection shall require reinspection or retest, as appropriate, to verify acceptability.
10.7 Records Records shall, as a minimum, Identify (a) througo (h) Selows (a)
Item inspected:
(b) date of inspection; (c)
Inspector:
(d) personnel (e) type of observation; (f) results or acceptability; (g) reference to information on action taken in connection with nonconformances.
(h) procedure / specification reference.
11.0
, TEST CONTROLS s
11.1 Applicabillty 4
All tests required to verify conformance of an item to specified requirements and to demonstrate that items will perform satisfac-torily in service shall be planned and executed.
11.2 Responsibility Test requirements and acceptance criteria shall be provided or approved by the organization responsible for the design of the item to be tested unless otherwise designated. It is the responsibility of the facility performing the test to adhere to the approved procedures.
The QC Monitors shall monitor all operations to assure compilance with this requirement.
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11.3 Test Requirements Required tests, including, as appropriate, prototype qualification tests, production tests, proof tests prior to installation, pre-opera-tional tests, and operational tests shall be controlled. Test require-monts and acceptance criteria shall be based upon specified require-ments contained in appilcable design or other pertinent technical documents.
11.4 Test Procedures Tests procedures shall include or reference test objectives and pro-visions for assuring that prerequisites for the given test have been met, that adequate ir.strumentation is available and used, that neces-sary monitoring 10 performed, and that suitable environmental condi-tions are maintained. Prerequisites shall include the following, as appilcables calibrated instrumentation, appropriate equipment, trained personnel, condition of test equipment and the item to be tested, suitable environmental conditions, and provisions for data acquisition.
11.4.2 In lieu of specially prepared written test procedures, appropriate sections of related documents, such as ASTM methods, Supplier man-uals, equipment maintenance instructions, or approved drawings or travelers with acceptance criteria, can be used. Such documents shall include adequate instructions to assure the required quality of work.
11.5 Test Results Test results shall be documented. Test results shall be reviewed by the facility manager or his delegate to assure that test requirements have been satisfied.
11.6 Test Records Test records shall, as a minimum, identify (a) through (g) belows (a) item tested; (b) date of test; (c) tester or data recorder; (d) type of observation; (e) results and acceptability; (f) all controlled equipment and materials used; (g) person evaluating test results.
12.0 CONTROL OF MEASURING AND TEST EQUIPMENT 25 of 38 QUALITY ASSURANCE PROGRAM 33.G.100
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12.1 Applicability hols, gages, instruments, and other measur'ng and testing devices or materials used in activities affecting quality shall be controlled.
12.2 Responsibility it is the responsibility of the facility using controlled measuring and test equipment to adhere to the requirements stated herein. The QC Monitor of each faellity shall monitor compliance with this require-ment.
12.3 Selection Selection of measuring and test equipment shall be controlled to assure that such items are of proper type, range, accuracy, and toler-ance to accomplish the function of determining conformance to spec-ified requirements.
12.4 Calibration and Control 12.4.1 Measuring and test equipment shall be calibrated, adjusted, and main-tained at prescribed intervals or, prior to use, against certified equip-ment having known valid relationships to nationally recognized stan-dards. If no nationally recognized standards exist, the bases for call-bration shall be documented.
12.4.2 The methods and interval of calibration for each item shan be defined, based on the type of equipment stability characteristics, required accuracy, intended use, and other conditions affecting meas-urement control. When measurh: and test equipment is found to be out of calibration, an evaluation anall be made and documented of the validity of previous inspection or test results and of the acceptability of items previously inspected or tested. Out of-calibration devices shall be tagged, segregated and not used untti they have be> recal!-
brated. If any measuring or test equipment is consistenti:.aund to be out of caubration, it shan be repaired or replaced. A calibration shall be performed when the accuracy of the equipment is suspect.
12.4.3 Calibration and cca rol measures may not be required for rulers, tape measures, levels, and other such deviacs, if normal commercial equipment provide:, adequate accuracy.
12.4.4 Measuring and test equipment and measurement standards shall be calibrated and utilized in an environment controlled to the extent e
necessary to assure continued measurements of required accuracy.
When applicable, compensating corrections shall be applied to call-bration results obtained in an environment which departs from stan-dard conditions.
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12.4.5 Written procedures shall be prepared or provided and utilized for calibration of all measuring and test equipment and measurement standards used to assure the accuracy of measurements involved in establishing product conformance. %c procedures may be a compila-tion of pblished standard practices or manufacturer % written instructions and need not be rewritten. As a minimum the procedures shall specify either the measurement standard to be used or the required accuracy of the standard.
12.5 l_Iandling and Storage l
Measuring and test equipment shall be properly handled and stored to maintain accuracy.
12.6 Records Records shall be maintained and equipment shall be suitably marked to indicate calibration status.
13.0 IIANDLING, STOR AGE. AND SlIIPPING 13.1 Applicability
%c handling, storage, shipping, cleaning, packaging, and preservation of all material, equipment, and items shall be controlled. %cse con-trols as applicable shall also be applied to received materials, cQ*aip-ment, and items.
13.2 Responsibility
%e shipping and inventory faellities shall assure that all require-ments of this section are complied with. He QC Monitor assigned to these facilities shall monitor all activities to assure compilance.
13.3 Ins truetion riandling, storage, and shipping of items shall be conducted in accor-dance with established work and inspection instructions, drawings, specifications, shipment instructions, or other pertinent documents or procedures specified for use in conducting the activity.
13.4 Requirements 13.4.1 When required for particular items, special equipment (such as con-tainers, shock absorbers, and accelerometers), and special protective environments (such as inert gas atmosphere, specific molsture con-tent :evels, and temperature levels) shall be specified, provided, and their e.xistence verified.
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13.4.2 When required for critical, sensitive, perishable, or high-value articles, specific procedures for handling, storage, packaging, ship-ping, and preservation shall be used.
13.4.3 Special handling tools and equipment shall be utilized and controlled as necessary to ensure safe and adequate handling. Special handling tools and equipment shall be inspected and tested in accordance with procedures and at specified time Intervals to verify that the tools and equipment are adequately maintained.
13.4.4 Operators of special handling and lifting equipment shall be exper-lenced or trained in use of the equipment.
13.5 Marking Instructions for marking and labeling for packaging, shipment, hand-ling, and storage of items shall be established as necessary to ade-quately identify, maintain, and preserve the item, including indi-cation of the presence of special environments or the need for special controls.
14.0 INSPECTION, TEST, AND OpER ATING STATUS 14.1 Appilcability
'Ihe status of all inspections and test activities shall be identified either on the items or in documents traceable to the items or mater-lals where it is necessary to assure that required inspections and tests are performed and to assure that items or materials which have not passed the regulred inspections and test are not inadvertently instal-led or used.
14.2 Responsibility
'Ihe person performing a given test or inspection shall document the results and indicate the status as required. Each facility supervisor shall assure that all required inspections and tests have been per-formed prior to the items or materials belnf used or released for shipment.
14.3 System of Identifying Status 14.3.1 Measures shall be established and documented to identify inspection and te t status. Such measures shall provide means for assuring that recuired inspections and tests are performed and that the accepta-bility of items with regard to inspection and tests performed is known. Nonconforming items shall be clearly identified.
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14.3.2 Bio status of inspections and test shall be indicated by the une of markings such as stamps, tags, labels, routing cards, or other suitable means.
14.3.3 Procedures shall be developed and implemented for control of status indicators including the authority for application und removal of tags, markings, labels and stamps.
15.0 NONCONFORMING M ATERIALS, PARTS. OR COMPONEN%
15.1 Applicability 15.1.1 All materials, parts, or components to be used by the testin; faellity which do not conform to requirements shall be controlled in order to prevent their inadvertent use or installation.
15.1.2 Materials, parts or components tested by the Company at the request of the purchaser which are found to be in noncompliance with appilcable specifications shall be identified and/or segregated where possible. Documentation of nonconforming !tems will be provided where test methods permit.
15.2 Responsibility 15.2.1 Die personnel performing the required inspections, tests, or examina-ticas shall be responsible for the prompt detection recording and verification of all nonconforming items and materials.
15.2.2 Vic Facility Manager shall be responsible for the technical review and disposition of all nonconforming items and materials intended for intornal use.
15.2.3 tie disposition and resolution of nonconforming materials, parts, or components tested by the Company at the request of the Purchaser shall be the responsibility of the Purchaser.
15.3 Identification (a)
Identification of nonconforming items shall
- marking, s
tagging, or other methods which shall not ac.trsely affect the end use of the item. Die identification shall be legible and easily recognizable.
(b)
If identification of each nonconforming item is not practical, the container, package, or segregated storage area, as appro-priate, shall be identified.
15.4 Segregation 29 of 38 QUAIXIT ASSURANCE PROGRAM 33.0.100
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(a)
Nonconforming items shall be segregated, when possible, by niacing them in a clearly identified and designated hold area hntil properly dlspositioned.
(b)
When segregation is impractical or impossible due to physical conditions, such as size, weight, or access limitations, other precautions shall be employed to preclude inadvertent use of a nonconforming item.
15.5 Disposition (Items intended for internal use) 15.5.1 Nonconforming characteristics shall be reviewed and recommended dispositions of nonconforming items shall be proposed and approved in accordance with documented procedures. Further processing, install-ation, or use of a nonconforming item shall be controlled pending an evaluation and an approved disposition by authorized personnel.
15.5.2 personnel performing evaluations to determine disposition shall have demonstrated competence in the speelfic area they are evaluating, have an adequate understanding of the requirements, and have access to pertinent background information.
15.5.3
'the final disposition, such as use-as-is, reject, repair, or rework, of nonconforming items shall be Identified and documented.
15.5.4 Technical justification for the acceptability of a nonconforming item, I
dispositioned repair or use-as-is, thall be documented. We as bullt records shall reflect the accepted deviation.
15.5.5 Repaired or reworked items shall be reexamined in accordance with applicable procedures and with the original acceptance criteria unless the nonconforming item disposition has established alternate accept-I ance criteria.
15.0 Reporting
'!he Identification of conditions adverse to established levels, the cause of the condition, and the corrective action taken shall be docu-i mented and reported to appropriato levels of management.
I 15.7 Reporting of Defects and Noncompliance (10CFR21) 15.7.1 Deviations identified in nuclear materials, parts or components through test inspection operations of the company shall be reported-to the purchaser or licensee for evaluation.
15.7.2
%e report of deviations shall be acknowledged by the signature of the recipient.
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15.7.3 A copy of the completed report shall be forwarded to the Director of Quality Assurance.
15.7.4
'Ihe disposition of the deviation shall be completed by the purchaser or licensco and the Company notified if re-examination is required.
15.7.5
'Ihe Company maintains the right to report any deviation directly to the Commission (NRC).
16.0 CORRECTIVE ACTIONS 16.1
_ Applicability All conditions adverse to quality, such as failures, malfunctions, defi-ciencies, deviations, defective materials and equipment, and non-conformances shall be promptly identified and corrected as soon as practical.
16.2 Responsibility
'Ihe quality control monitor shan be responsible for identifying and reporting nonconforming conditions to the appropriate levels of man-agement. 'they shall also be responsible for verification that appro-priate corrective actions have been implemented. Corrective actions shall be implemented by the facility responsible for the process involved.
16.3 Requirements 16.3.1 Procedures shan be developed and implemented to assure that all conditions adverse to quality including unsatisfactory practicos are corrected by responsible management and technical personnel.
16.3.2 in the case of a significant condition adverse to quality, the cause of the condition shall be determined and corrective action taken to preclude recurrence. 'Ihe identification, cause, and corrective action for significant conditions adverse to quality shall be documented and reported to appropriate levels of management.
16.3.3 Follow-up action shall be taken to verify implementation of correc-tive actions.
17.0 QUALITY ASSURANCE REC 3RDS 17.1 Applicability Sufficient records shall be maintained to furnish evidence of activi-ties affecting quality.
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17.2 Responsibility ne facility that generated the required records shall be responsible for their validation, indexing, distribution identificatfor., classiil-cation, retention, correction, preservation, safekeeping, retrieval, and disposition.
17.3 Records Administration 17.3.1 A records system (s) shall be established by the organization respon-sible at the earliest practicable time consistent with the schedule for accomplishing work activities and in compliance with the general requirements of this program. %e records system (s) shall be defined, implemented, and enforced in accordance with written procedures, instructions, or other documentation.
17.3.2
%e appilcable design specifications, procurement documents, test procedures, operational procedures, or other documents shall specify the records to be generated, supplied, or maintaincd. Documents that are designated to become records shall be legible, accurate, and completed appropriate to the work accomplished.
17.3.3 Documents shall be considered valid records only if stamped, initialed, or signed and dated by authorized personnel or otherwise authenticated. 318 authentication may take the form of a statement by the responsible individual or organization. !!andwritten signatures are not required if the document is clearly identified as a statement by the reporting individual or organization. Ecsc records may be originals or reprodcced copics.
17.3.4
%e records shall be indexed. %e indexing system (s) shall include, as a minimum, record retention times and the location of the record within the record system.
17.3.5
%c records shall be distributed, handled, and controlled in accord-ance with written procedures.
17.3.6 Records and/or indexing system (s) shall provide sufficient informa-tion to permit identification between the record and the item (s) or activity (les) to which it applies.
17.3.7 Records shall be classified as QA or QC by the owner, or his agent when authorized, in accordance with the criteria given in (a) and (b) below.
(a)
Q A records are those that meet one or n: ore of the following criteria:
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(1)
Those which would be of significant value in demonstrat-Ing capability; (2) 1 hose which would be of significant value in maintalning, reworking, repairing, replacing, or modifying an item; (3)
Those which would be of significant value in determining the cause of an accident or malfunction of an item; (4)
Those which provide required baseline data for service performed on equipment; QA records are required to be maintained for the life of the particular item or 10 years, whichever is longer.
(b)
QC records are those required to show evidence that an activity was performed in accordance with the applicable requirements but need not be retained for the life of the item because they do not meet the criteria for lifetime records.
17.3.8 RecoMs shall be retained in accordance with the above classifica-tions. The retention period for nonpermanent records shall be esta-blished in writing.
17.3.9 Records may be corrected in accordance with procedures which pro-vide for appropriate review or approval by the originating organi-zution. The correction shall include the date and the identification of the person authorized to issue such correction.
17,4 Receipt 17.4.1 The individual or organization responsible for receiving records shall provide protection from damage or loss during the time that the records are in their possession.
17.4.2 Each organization responsible for the receipt of records shall desig-nate a person or organization rorponsible for rocciving the records.
1he designee shall be responsible for organizing and implementing a system of receipt control of records for permanent and temporary storage. As a minimum, a roccipt control system shall include the following:
(a) a method for designating the required records; (b) a method for identifying records roccived; (c) procedures for receipt and inspection of incoming records; 33 of 38 QUALITY ASSbkANCE PROGRAM 33.G.100
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17.4.3 Each receipt control system shall be structured to permit a current and accurate assenament of the status of records during the rocciving process.
17.5 Storage. Preservation and Safekeeping 17.5.1
'Ihe records shall be stored in predetermined location (s) that meet the requirements of appilcable standards, codes, and regulatory agencies. Prior to storage of records, a written storage procedure shall be prepared and responsibility assigned for enforcing the requirements of that procedure. This procedure shall include, as a minimum, (a) through (g) below:
(a) a description of the storage facility; (b) the filing system to be used; (c) a method for verifying that the records received are in agree-ment with the transmittal document and that the rcoords are legible (d) a method of verifying that the records are those designated (see 17.4.2 above);
(e) the rules governing access to and control of the files; (f) a method for maintaining control of and accountability for records removed from the storage faellity; (g) a method for filing supplemental information (see 17.3.0) and disposing of superseded records.
17.5.2 Records shall be stored in a manner approved by 'she organ!zation or organizations responsible for storaga. In order to preclude deteriora-tion of the records the requirements of (a) through (c) below shall apply.
(a)
Provisions shall be made in the storage arrang. ment to prevent damage from moisture, temperature, and pressure.
(b)
Records shall be firmly attached in binders or placed in folders or envelopes for storage in steel file cabinets or on shelving in containers.
(c)
Provisions shall be made for special processed records (such as radiographs, photographs, negatives, microform, and magnetic media) to prevent damage from excessive light, stacking, elect-romagnetic fields, temperature, and humidity.
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17.5.3 Measures shall be established to preclude the entry of unauthorized norsonnel into the storage area. 7hese measures shall guard against larceny and vandalism.
Measures shall be taken to provide for replacement, restoration, or substitution of lost or damrtgcd records.
17.5.4 Records shall be stored in facilities constructed and maintained in a manner which minimizes the risk of damage or destruction from the following (a) natural disasters such as winds, floods, or fires; (b) environmental conditions such ar. high and low temperatures and humidity; (c)
Infestation of insects, mold, or rodents.
'!here are two satisfactory methods of providing storage facilities, single or duel.
17.5.4.1 Design and construction of a single record storage facility shall meet the criteria of (a) through (c) below:
(a) reinforced concrete, concrete block, masonry, or equal con-struction; (b) a floor and roof with drainage control. If a floor drain is pro-vided, a check valve (or equal) shall be included; (c) scalant applied over walls as a moisture or condensation barrier; (d) surface scalant on floor providing a hard wear surface to mini-mize concrete dusting; (e) foundation scalant and provisions for d alnage; if the faellity is located within a building or structure, the environ-ment and construction of that building can provide a portion or all of these criteria.
17.3.4.2 If storage at dual facilities for each record is provided, the facilities shallbe at locations sufficiently remote from each other to eliminate the chance of exposure to a simultaneous hazard. Each faellity is not required to satisfy the requirements of 17.5.4.1 above, but shall meet the other requirements of this Program.
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Storage systems shall provide for retrieval of information in accor-dance with planned retrieval times based upon the record type.
Records maintained by a Supplier at his facRity or other location shall be accessible to the Purchaser or his designated alternate.
17.7 Disposition For records accumulated at various locations, the custodian shall inventory the submittals, acknowledge roccipt, and process these records in accordance with this Program.
Various regulatory agencies have requirements concerning records that are within the scope of this Program. 'Ihe most stringent requirements shall be used in determining the final disposition.
Nonpormanent records shall not be disposed of untti the applicable conditions listed in (a) through (d) below are satisfied.
(a)
Items are released for shipment; (b)
Regulatory requirements are satisfied; (c)
Warranty consideration is satisfied; (d)
Purchasce's requirements are satisfied.
18.0 AUDITS 18.1 Appilcability Planned and scheduled audits shall be performed to verify compliance with the quality assurance program and to determine its effective-ness.
18.2 Responsibility
'Ihe Quality Assurance Department shan be responsible for conduct-ing all audits, reporting the results of the audits, and evaluating the audit responses.
18.3 Scheduling Internal or external quality assurance audits, or both, shall be sche-duled in a manner to provide coverage and coordination with ongoing quality assurance program activities. Audits shall be scheduled at a frequency commensurate with the status and importance of the activity.
'Ihe audit schedule shall be reviewed periodically and revised as necessary to assure that coverage is maintained current.
Regularly scheduled audits shall be supplemented by additional audits of specific subjects when necessary to provide adequate coverage.
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18.4 1Yeparation 18.4.1 The auditing organization shall develop and document an audit plan for each audit. This plan shallidentify the sudit scope, requirements, audit personnel, activities to be audited, organizations to be notified, applicable documents, schedule, and written procedures or checklists.
18.4.2
'Ihe auditing organization shall select and ass!gn auditors who are independent of any direct responsibility for performance of the activ-it!cs which they will audit. In the case of Internal audits, personnel having direct responsibility for performing the activitics bcIng audited shall not be involved in the selection of the audit team.
Audit personnel shall have suffielent authority and organizational freedom to make the audit process meaningful and effective.
18.4.3 An audit team shall be identified prior to the beginning of each audit.
This team shall contain one or more auditors and shall have an indivi-dual appointed to lead the team who organizes and directs the audit, coordinates the preparation and issuance of the audit report, and evaluates responses.
The audit team leader shall ensure that the audit team is prepared prior to initiation of the audit.
18.5 performance Audits shall be performed in accordance with written procedures or checklists as early in the life of the activity as practical and shall be continued at intervals consistent v lth the schedule for accomplishing the activity. Elements that have been selected for audit shall be evaluated against specified requirements. Objective evidence shall be examined to the depth necessary to determine if these elements are being implemented effectively.
Audit results shall be docu-monted by auditing perscanel and shall be reviewed by management 1
having responsbility fo+ the area audited.
Conditions requiring prompt corrective actbn shall be reported immediately to manage-ment of the auditnd organization.
18.6 Reporting The audit report shall be signed by the Director of Q A and issued to management. The report shall include the following information, as appropriates (a) description of the audit scope; (b) identification of the auditors; (c) identification of persons contacted during audit activities; 37 of 38 QUALITY ASSURANCE pHOGil AM 33.G.100 l
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(d) summary of audit results, including a statement on the effee-tiveness of the quality assurance program elements which were I
audited; I
(e) description of each reported adverse aud!t finding in sufficient detall to enable corrective action to be taken by the audited organization.
18.7
Response
Management of the audited organization or activity shall investigate adverse audit findings, schedule corrective action, including measures to prevent recurrence, and notify the appropriate organization in writing of action taken or planned. The adequacy of audit responses shall be evaluated by or for the auditing organization.
18.8 Follow-up Action Follow-up action shall be taken to verify whether corrective actior is i
l accomplished as scheduled.
18.9 Records l
Audit records shall include audit plans, audit reports, written replies, and the record of completion of corrective action.
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h APPENDIX 1 QU ALITY TERMS AND DEFINITIONS
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%1s section contains certain terms and their definitions that are important to the understanding of this Quality Assurance Program and the related procedures and documents.
Acceptance
%e quality or state of being accepted, in that results of tests, inspection or examination results within spec 'ed limits may meet acceptance.
Amendment An addendum or change in a procedure to allow its use in special situations.
Approval An act of ondorsing or adding positive authorization or both.
Audit An activity to determine through investigation, the adequacy of, and adherence to, established procedures, instructions, spec-ifications, codes, and standards or other applicable contractual and lleense requirements, and the effectiveness of implementa-tion.
Calibration To determine the deviation from a standard so as to ascertain proper correction factors and/or adjust eteordingly.
Certificate of A written statement, signed by a quallfled party, attesting that Compliance the items or services are in accordance with specified require-ments and accompanied by additional information to substanti-ate the statement.
Certificate of A written statement, signed by a qualified party, certifying Conformance that items or services comply with specific requacments.
Certification
%e action of determining, verifying and attesting in writing, to the qualifications of personnel or material.
Client
%at firm or person engaging the services of the Company.
Component A piece of equipment or item such as a vessel, piping, pump, valve or structure which will be combined with other compon-ents to form an assembly or unit.
Conformance Meeting the physical characteristics (within tolerances) pro-scribed by a specification or standard.
Contractor An organization under contract for furnishing items or services.
It includes the terms, vendor, supplier, sub-contractor, fabri-cator and sub-levels of these where appropriate.
Controlled
%e regulation of documents in that their issue, use and revision and retrieval is restrained.
Al QU ALITY ASSUll ANCE PitOOlt AM - APPENDIX 1 33.G.100
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Correction A change to e document which doc 9 not change the technical contents but changes something which was in error, i.e., spell-Ing, numbering errors, punctuations, omissions. (See IMvision)
Defect A discontinuity whose size, shape, orientation, location or pro-perties make it detrimental to the useful service of the part in which it occurs or which execeds the accept / reject criteria for the g'ven design.
Defootive A material or component which has one or more characteristics Material that do not comply with specified requirements.
Deficiency
'Iho state of lacking of quality or eleinent, resulting in a situa-tion that is not up to standard.
Discontinuity Any interruption in the normal physical structure or configura-tion of a part, such as cracks, laps, seams, inclusions, or poro-sity. A discontinuity may or may not affect the usefulness of i part.
Document A communication, instruction, report or record wherein the contents are written and subsequently becomo evidence.
Documentation Any written or pictorialinformation describing, defining, specifying, reporting or certifying setivities, requirements, procedures or results.
Examination An element of inspection consisting of investigation of mate-rials, components, supplies or services to determine confora mance to those specified requirements which can be determined by such investigation. Examination is usually nondestructive and includes simple physical manipulation, gaging and measure-ment.
Facility A Company laboratory, field office, project or function snat is built or established to service a particular purpose, Field
'j Referring to activity that is performed outside a laboratory or project, usually referring to a job of short duration.
Guidelines Particular provisions which are considered good practico out which are not mandatory in programs intended to comply with this standard. 'the term "should" denotes a guldeMne; the term "shall" denotes a nandatory requirement.
Inspection A phar.o of quality control which by means of exarnination, observation or measurement determines the conformance of materials, supplies, components, parts, appurtenances, systems, processes or structures to pre-determined quality requirements.
A2 QUALITY ASSUR ANCE PROGRAM - APPENDIX 1 33.0.100
MQS INSPECTION, INC, item Any level of unit assembly, including structure, system, sub-system sub-ussembly, component, part M ma terial.
Laboratory A facility built or estatL* ed to p vvide te-4, inspection and examination services.
Manual A written document containing instrust4ns 2nd/or procedures.
Material A substance or combination of substances such as penetrants, powders, film, couplants, etc.. used in testing, inspeedon and examinations.
Method Refers herein to the various disciplines of test, inspection and examination processes, such as radiography, ultrasonics, etc.
Modification A planned change in design or operation and accomplished in accordance with the requirements and limitations of applienble codes, standards, specifications, lleenses and prc-determined safety restrictions.
Monitor (QC)
A quallfled person employed sy the Company having authorized jurisdiction at facility whose dutics include the verification of quality related activitics or installation or both.
Monitoring
'Ib watch, observe or check a process or procedure as a part of regulating quality.
Nonacceptance
'!he quality or state of not being acceptabic, in that results of tests, inspections or examinations are not within specified limits.
Nonconformance A deficiency in characteristic, documentation, or procedure which renders the quality of an item unacceptable or indeter-minate. Examples of nonconformance include: Physical defects, test failures, incorrect or inadequate documentation, or deviation from prescribed processing, inspection or test pro-cedures.
Nondestructive Examination (also referred to as testing, inspection, etc.), to Examination detect internal, surface and concealed conditions and defects or (NPE) flaws in materials using techniques that do nat damage or destroy the item being examined.
Part An item which has work performed on it and which is attached to and becomes part of a component before completion of the component.
A3 QU ALITY ASSUR ANCE PltOGItAM - APl'ENDIX 1 33.G.100
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Performance Meeting the functional or mechanical characteristi tt, presetibed by a specification or standard.
Procedure A document that specifies or describes how an activity is to be performed. It may include methods to be employed, equipment or materints to be used and scouence of operation.
i Procurepient Contrcctually binding documents that identify and define the 9ocuments requirements which items or services must meet in order to bc considered acceptable by the purchaser.
Pro >ct An operation other than a laboratory or field job because of its specific require acnts and not a permanent facility.
n
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Cuallf cation
%e characteristics or abilities galned through training or (derronnel) experience or both that enables an individual to perform a required function.
Qualified A procedure which incorporates all appilcable codes and str.n-l s
Procedure darde, engineering specifications and has been proven adequate for its intended purpose.
Quality All those planned and systematic actions necessary to provide Assurance adequate confidence that an item or a facility will provide (Q A) satisfactorily in service.
Quality
%ose quality assurance actions which provide h means to verify Control the conformance of an item or proces' to speelfled requirc-(QC) ments.
Receiving hking delivery of an item at a designated location.
i
- Records, All records generated from test and inspection and quality Internal assurance activities.
I*
Reject /
Usually referring to an item tested, inspected and/or examined 4
Rejected Parts and not meeting acceptance Jtandards.
Repair
%e process of restoring a nonconforming characteristic to n condition such that the capability of the stem to function rell-ably and safely is unimpaired even though the item still may not conform to the original specification.
Report A document that records information for record purposos.
Revision A change in a procedure or document to update or improve. A revision changes the technical contents of the document. (Sco Correction)
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Rework The process by which a nonconforming item is mata to conform to a prior specified requirement by completion, remachining, reassembling or other correctivo means.
Shall Tils work is a directive indica <ing a mandatory requirement.
Should Tils work is a suggestion indicating a desirable requirement that is not necessarily mandatory.
Specification A concise statement of a set of requirements to be satisfied by a product, a material or process indicating whencycr appro-priate, the procedure by means of which it may be Cctarmined whether the requirements given are satisfied.
S h iard Tie result of a particular standardiza'Jon offort approved by a recognized authority.
Supplier A firm that supplies items or services as ordered.
Surveillance Witnessing or monitoring an operation or system.
System A group c' subsystems united by some interaction or inter-dependence, performing many duties but functioning as a single unit.
Technician A qualified person who uses a procedure, equipment and/or materials to perform certain tests and examinations.
Technique A metLad of accomplishing a particular test, inspection and/or e(amination and referring to a record detailing the procedure u se.
Testing The determir.ation or verification of the capability of an item to meet specified requirements by subjecting the item to a set of physical, chemical, e..vironmental or ope iting conditions.
"St Program A specific program which deliniates the frequency of tests, the applicable specifications, reporting requirements and in some cases, acceptance criteria.
Test Report A document prepared showing the results of a test, inspection and/or examination.
Uncontrolicd Referring to documents that are not regulated in their distribu-tion, use or retrieval.
Verification An ac+. of confirming, substantiating and assuring that an activ-ity or condition has been implemented in conformance with the specified requirements.
A5 QU ALITY ASSUR ANCE PROGR AM - APPENDIX 1 33.G.100 1
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- 1-(800)638 5227,(Ithrns, Alaska and Hawan,pleasecall(708)9818777) 4
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c OTH, ER LOCATIONS -
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! Buffala NY *MNcaggIC'* Cincinnati, OH *: Cleetand, OH *- Denwr, CO * - - Detroit, Mt WHstford, CN 4
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- Jacksorwille, FL * ' Los Angeles, CA'r *..- Mernphis, TN.* MAvaukee, Wl,yii?
4 Minneapolis, MN 1* J. Hampton, W. *;. PhiladelpNa, PA
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