ML19309B645
| ML19309B645 | |
| Person / Time | |
|---|---|
| Site: | 07100185 |
| Issue date: | 04/01/1980 |
| From: | FBF, INC. |
| To: | |
| Shared Package | |
| ML19309B644 | List: |
| References | |
| 15746, QA5, NUDOCS 8004070022 | |
| Download: ML19309B645 (85) | |
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Document No.-
QA 5-1
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FBF, Incorporated.
1201 Hilton Road t!!ddlebrook Industrial Park Knoxville, Tennessee 37921
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Phone 615/584-1868 4
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MASTER QUALITY ASSURANCE PROGRAM Updated Effective April 1, 1980 in accord with 10 CFR Part 71 Appendix E e
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FBF INC. - QA PROGRAM INITIAL RECORD OF-REVISIONS Name Date Prepared by H. Stringfield QA Manager June 10. 1971 Preoared by H. Stringfield QA Manager November 18, 1973 Prepared by H. Stringfield OA.stanaxcr June 1, 1975 Prepared by H. Stringfield QA Manager July 1, 1978 Prepared by li. - Strincfield QA thnager Anril 1. 1980
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Issue Change Std. No.
Date Sec./ Para.
Descriotion
~ t-QA 4 7/1/78 All sections to comply with s
changed 10 CFR Appendix E QA $
h/1/80 All nections to comply with !!RC l
updated review of QA Itogram -
assuring connliance with i
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FDF INC. - OA PROGRAkt TABLE OF CONTENTS SECTION TITLE PAGE INTRODUCTION 1
1.0 ORGANIZATION 2
2.0 QUALITY ASSURANCE PROGRAM 4
3.0 DESIGN CONTROL 6
4.0 PROCUREMENT DOCUMENT CONTROL 9
5.0 INSTRUCTIONS, PROCEDURES, AND DRAWINGS 10 6.0 DOCUMENT CONTROL 11 7.0 CONTROL OF PURCHASED MATERIAL, EQUIPMENT 13 AND SERVICES 8.0 IDENTIFICATION AND CONTROL OF MATERIALS, 15 PARTS, AND COMPONENTS 9.0 CONTROL OF SPECIAL PROCESSES 17 10.0 INSPECTION 17 11.0 TEST CONTROL 20 12.0 CONTROL OF MEASURING AND TEST EQUIPMENT 21 13.0 HANDLING, CLEANLINESS, PRESERVATION, PACKAGING, 23 SHIPPING AND STORAGE 14.0 INSPECTION, TEST, AND OPERATING STATUS 24 15.0 gos. CONFORMING MATERIAL, PARTS, OR COMPONENTS 25 16.0 CORRECTIVE ACTION -
26 17.0 QUALITY ASSURANCE ~ RECORDS 27 18.0 AUDITS 29 APPENDIX A GLOSSARY OF TERMS 1 of 5 thru 5 of 5 l
ISSUE DATE:
7/1/78 SERIAL OA4 '
h/1/80 SalIAL QA5
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INTRODUCTION -
1.
Puroose 7/1/78 FBF, Inc. is engaged in the design, manufacture, testing, evaluation, repair and refurbishing of various types of radioactive material shipping containers, and the manufacture of radiation detection equipment such as I
flim badge holders for personnel' dosimetry.
FBF does not engage in the handling or shioment of radioactive materials as a user of the containers, such as recuired by Licensees for shipment of radioactive material packages.
I The radioactive material shlooing containers that FBF manufactures repre-i sents an integral part of the total package for which the Licensee is resoonsible.
It is the goal and major objective of FBF Inc. to manufacture high
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quality shioning containers, in full compliance with 10 CFR Part 71 Apoendix E, for sale to the Licensee or container users for use in making shtoments of radioactive materials.
2.
Scooe Pursuant to Section 71.51, of 10 CFR part 71, " Packaging of Radioactive Materlat for Transport and Transportation of Radioactive Material Under Certain Conditions," a manufacturer of containers must establish, maintain and execute a quality assurance program for the basic shipping container oortion of'shioning occkages which transport certain quantitles of radioac-tive material.
The FBF Inc. quality assurance orogram satisfies each of the aoolicable (to container manufacturers) criteria specified in Aooendix E to 10 CFR Part 71, " Quality Assurance Criteria for Shioping Containers' (packages are the responsibility of the Licensee) for Radioactive Material," and must also
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' satisfy any specific provisicas which are aoolicable to the container manu.
facturer's activities or portion concerning shlooing onekages.
The quality assurance program, then, is made up of general and soccific provisions. The 6
general provisions of the program are based on the Appendix E criteria. The requirements of Appendix E are apolled in a graded aporoach, i.e.,
noolled to an extent consistent with their importance to safety.
The specific pro-visions of the quality assurance program, including specific tests, opera-tions, and acceptance criteria for the particular container to be constructed or manufactured are speelfled in federal regulations and package soprovals.
Additional QA (of manufacturing containers) orocedures are included in the apoendices of the QA program. New sections or aopendices will be added as l
required when FBF Inc. becomes engaged in phases of work or manuf acture requiring additional procedures under the general 10 CFR Part 71 Appendix E criteria.
(1) Organization 7/1/78 i
The authority ~and duties of persons and organizations performing quality assurance functions are clearly established and delineated in writing.
Such person (s) have sufficient authority and organizational freedom to iden-tify quality problems; to initiate, recommend, or provide solutions; and to verify implementation of solutions.
In general, assurance of quality reoutres management measures which provide that the individual (s) assigned the respon-sibility for checking, auditing, inspecting, or otherwise verifying that an I
activity has been correctly performed is indcoendent of the individual or group.directly resoonsible for performing the soecific activity. The President h
I of.FBF, Inc., regularly revious.the status and adequacy of the quality casurance program, and, of course, establishes FBF, Inc. QA policies, goals R
and objectives.
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The FBF,-Inc. criteria.as part of the quality assurance prograni are:
-The responsibility for the QA program is retained and exercised by a.-
FBF Inc. management and.cuallfled CA/QC personnel.
b.
The QA/0C functions, performed by the FBF QA orgainzation or dele.
gated to other organizations, are-identified and described, providing controls to assure appropriate elements of Appendix E will be implemented.
Clear and ef fective lines of communicat tor. between the QA organi.
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zations of FBF and it's princloal suopliers are established to assure oruper direction of the QA program and resolution of QA problems.
d.
Organization charts identify the organizational elements which function under the control of the QA program (such as, Design Engineering, Procurement, Manufacturing, Inspecting (OC), Testing, and QA) and demonstrate adequate control over cuality aspects within and between organizat ions.
The interface relationships and QA responsibilities of each organ-e.-
Izational element identified in item d above are described and demonstrate assignment of responsibilities for requirements of Accendix E.
- f. The President of FDF, Inc. is responsiblo for establishing the F
1 FBF QA policies, goals, and objectives and this management level maintains i
a continuing involvement in QA matters. Communication through any interme-diste levels of management between this position and the manager of QA have been shown to be effective.
g.
FBF designates a position, Manager of Quality Assuranco, specifying dutics and qualifications to be filled by a qualified individual, to retain overall authority and responsibility for the QA progran, h.
The authority and indeoendence of the individual responsibic for managing the QA program are such that he can direct and control the 1
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= organization's;QA/QC program, can effoctively assure.the ;conformance' to
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qua'ity requirements', Land is independent of undue. influences'and responsi-l
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N bibities for schedules and costs. The organizational structure has this individual report to the company president.
i ~.. The qualification requirements for the principal QA/QC management position (s) demonstrate competence commensurate.with'the responsibilities of-Y
-these positions.
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Vorification of conformance to established requirements is accom-
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plir.hed by individual (s) who do' not have direct' responsibility for performing the uork being verified.
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Designated QA individual (s) have the responsibility and authority, delineated in writing,'to stop unsatisfactory work and control.further-processing, delivery, or. installation of nonconforming material.
(See Appendices: 1-1 Qualifications of FBF, Inc. QA Manager; 1-1A Quality D.
Assurance Organizntion Chart;-1-1B QA Functional Chart; 1-1C QA Responsibilities-and Interface Relationships.
(2)_ Quality Assurance lYogram 7/1/78
-Quality assurance comprises all-of those planned and systematic' actions necessary to provide adequate confidence that a transportation package vill perform satisfactorily in service. It is important that FDF have an adequate quality assurance-program to ensure that a container for a package,
-l(and. its use,) have the reliability on which the safety and performance of
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the package _ucre evaluated.
.The FBF criteria'as part of a quality assurance program are:
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'n.i The Frosident of FDF,:Inc. (i.e., above-or.outside the QA organization)'
F 1 regularly, assesses the. scope, status,-implementation, and offcctiveness of the
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E 9A program to assure that the progran is adequate and complies uith 10 CFR
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-3 Phrt)71, Appendix E criteria.
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b.
Measures are provided by FBF to assure that trained quallfled oersonnel within his organization are assigned to determine that i-f unct ions delegated to his princlent supollers'are being properly accomolished.
A brief summary of the Company's corporate QA oolicies, goals, c.
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~ and objectives is gl'en and a meaningful-channel for transmittal of these v
policies, goals, and ~ objectives down through the levels of' management is established.
Each suocrvisor is required to read and follow the QA/QC manual.
d.
QA/QC responsibilities are designated for the implementation of the major activities contained in the OA manunts.
Provisions are established to control the distribution of the QA e.
i manunts and revisions thereto. All suocrvisors are on the distribution of the OA/QC manuals and check-off sheets.
f.
Provisions are established for communicating to all responsible individuals that quality oolicies, QA manuals, and procedures are mandatory requirements which must be inclemented and enforced.
A listing of the QA procedures plus a matrix of these procedures g.
cross referenced to each criterion of Anoendix E to 10 CFR Part 71 demon.
strates that Apoendix E orovisions are fully lmolemented by documented procedures.
t h.
The safety-related systems, structures nnd comoonents controlled by the QA program are identified.
See nooroorlate QC check-off sheet.
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b FBF reviews and documents agreement with the QA program provisions of it's principal supollers to the extent that can be assured Anoendix C will d
be implemented.
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'j.. Provisions are established for the resolution of disputes i.nvolving quality, arising from a difference of opinion'betwoon QA/QC perso'nnel'and other departnent (engineering, procurement, manufacturing, etc.) personnel.
All'such disputes are resolved by decision of_the President of FBF, Inc.
R-following a thorough reviou and discussion of the differing vieus and opinions.
k.
An indoctrination and training program is established such that:
(1) Personnel responsible for performing quality-related activitics are instructed as to the purpose, scope, and implementation of the QA manuals, instructions, and procedures.
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-- (2 ) Personnel performing quality-affecting activitics are trained and qualified.in the principles and techniques of the activity being performed.
(3) The scope, the objective, and the method of implementing the indoctrination and training program are documented.
(h) Proficiency of personnel performing quality-affecting activitics-
'is maintained by retraining, reexamining, and/or recertifying.
1.
Quality-related activitibs are performed with specified equipment under cultable environmental conditions, and proroquisites have been satisfied prior to inspection and ~ test.
(See Appendices: 2-1 Brief summary of FBF, Inc. QA policies, goals, and objectives:
2-1A lhtrix of QA Procedures referenced to criterion of Appendix E to CFR i
Part 71;.2-1B 3afety related systens, structures and components controlled by the QA program; 2-10. Resolution of disputes involving quality botueen QA/QC
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personnel and other departnents ).
(3) Design Control' 7/1/78 PDF takes measures to accure that applicabic regulatory requirements
-and the necessary design features arc correctly translated into specification,
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- - ' constructionidrawings, proce'dures and instructions.; 'i review of thE-
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j design'is ando by individuals (s) other.'that those involved in the. original:-
idesign,:but..who may be.from ths samel organization..
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7 The design review cover items such as; stress, thermal, radiation, shielding, and accident analyses as set forth in DOI or NRC specifications; compatibility of materials; inspection, maintenance, and repair; and delinen-tion of acceptance criteria for inspections and tests.
Reports of in.orocess and final design reviews are reviewed by management.
Design changes, included production line or fleid changes, are reviewed by the oerson(s) from whom the design originated.
The FBF - critoria as part of a quality assurance progran are:
R-1 Measures are established to carry out design activities in a a.-
p la nned, controlled, and orderly manner.
However, for the most part and j
l certain special exceptions, FBF simply follows the design already approved by DOI and/or NRC.
- b.. Measures are established to correctly translate the apolicable regulatory requirements and design bases into specifications, drawings, written procedures,-and instructions.
Quality standards are specified in the design. documents, and devia-c.
tions and changes from these quality standards are controlled, Suitable design controls are apolled to such activities as stress, d.
thermal, hydraulle, radiation, and accident analyses; compatibility of materials; and necessibility for inservice insocction, maintenance, and repair.
Designs are revicued by FBF, Inc. President to assure that (1)
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design charactoristica can be controlled, inspected, and tested and (2) inspection and test critoria are identified. Competent connultnnts are usually engaged by FBF, 'Inc. for design activitics and the President of n_1 FBF, Inc. coordinates both the work and contract for design.
- f.. Internal and extern.1 design intorface controls are established.
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8 These controle include the review, arproval, relcaso, distribution, and revision of documents involving design interfaces with participating design organizations. The Itosident of FDF, Inc. is restsonsible for reviewing, R-1 approving, and directing the issuance of documents and revisions thereto.
g.
Proper selection and accomplishment of design verification or checking processes such as by design reviews, alternate calculations, or qualification testing are performed.
When a test program is used to verify the adcquacy of a design, a qualification test of a prototype unit under design conditions is used, h.
Individual (s) responsible for design verification are other than the original designer and the designer's immediate supervisor.
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Design ond specification changes, including field changes, are subject to the same design controls and approvals that were nop11 cable to the original design unless FDF designates another quallfled responsible organ!zatlon, j
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Errors and deficiencies in the design, including the design
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process, that d.
could adversely affect safety-related systems, structures a
3 and comoonents are documented; and corrective action is taken to preclude l
repetition, k.
Materials, parts, and equipment which are standard, commercial 1
l (of f-the-shelf) or which have been previously approved for a dif ferent j
application are reviewed for suitability orlor to selection.
- 1. -The position (s) responsible for design reviews and other design verification activities and their authority and responsibility are identified q-and controlled by written procedures.
Measures are established for the selection of suitable materlats, m.-
parts, equipment, and processes for safety-related systems and components which include the use of valid industry standards and specifications.
(See Appendix 3-1 Design Control) n_;
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- (4) Procurement Document Control 7/1/78 FBF-takes measures to assure that all purchased material, equipment, parts and services meet the design specifications. Provisions include measures for source' evaluation and selection, objective evidence of quality' furnished by the supplier, inspection at the source, and examina-tion of products upon delivery. ~The effectiveness of the suop11er's quality assurance program is assessed at intervals consistent with the importance, complexity and quantity of the product or services. The latest drawings and speelfications are included in any procurement procedures.
FBF criteria as part of a quality assurance program are:
Procedures are established that clearly delineate the sequence a.
of actions to be accomplished in the preparation, review, approval, and I
control of procurement documents.
b.
A review and concurrence of the adequacy of quality requirements f
stated in procurement documents is performed by qualified personnel.
This j
review determines that quality requirements are correctly stated, inspect-i able, and contro11ablet there_are adequate acceotance and rejection criteria; and the orocurement document has been orepared, reviewed, and approved in
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accordance with QA program requirements.
c.
The review and approval of procurement documents are documented prior to release and available for verification.
il d.
Procurement documents identify the applicable 10 CFR Part 71 Appendix E requirements which must be como11cd with and described in the supoller's QA program. This QA program ur portions thereof shall be reviewed and concurred with by quallfled personnel in QA prior to initla-tion of activities affected by the program.
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10 Procurement documents contain or reference the design basis e.
technical = requirements including the aoolicable regulatory requirements, s.
i material-and' component identification requirements, drawings, specifica.
I-tions, codes and industrial standards, test and inspection requirements, i
and'special orocess instructions.
f.
Procurement documents identify the documentation (e.g., drawings, specifications, procedures, inspection and fabrication plans, inspection and test records, personnel-and procedure cuallfleations, and chemical and physical test results of material) to be prepared, maintained, and submitted to the= purchaser for review and approval, Procurement documents identify those records to be retained, g.
controlled, and maintained by the supoller, and those delivered to the purchaser prior to use or installation of the hardware.
h.
Procurement documents contain the FBF Inc.'s right of access to supoller's facilities and records for source inspection and audit.
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Changes and revisions to procurement documents are subject to at least the same review and approval as the original document.
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Procurement documents for spare or replacement parts of safety-rel'ated systems and components are subject to controls at least equittalent to those used for the original couloment.
(See Aooendix 4 1 Vendor Evaluaticn)
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Instructions, Procedures, and Drawings 7/1/78 Activities affecting quality should have written Instructions, procedures, and drawings, when necessary to control those aspects of quality.
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11 The FBF criterin as part of a quality assurance program are:
Act ivit ies a f f ect ing quality are prescribed and accomolished in a.
accordance with documented-instructions, procedures, or drawings, b.
Provisions are established which clearly delineate the sequence of actions to be accomolished in the preparation, review, aooroval, and control of instructions, procedures, and drawings.
c.
Methods for comolying with each of the applicable 18 criteria of Aooendix E to 10 CFR Part 71 are specified.in instructions, procedures, and
- drawings, d.
Instructions, procedures, and drawings include quantitative (such as dimensions, tolerances, and operating limits) and qualitative (such as workmanship samples) acceptance criteria to verify that important
. activities have been satisfactorily accomolished.
The QA nanager revicus and concurs trith inspection plans; test, R-1 e.
calibration, and special process procedures; drauings and specifications; and changes thereto or acceptable alternativos are described. The Itesident of R-1 FBF, Inc. over-vicus the uork of the QA manager to assure full compliance with Appendix E to 10 CFR Part 71.
(See Appendix 5-1 Instructions, Procedures, and Drawings)
(6) Document control 7/1/78 FBF takes measures to control the issuance of documents, such as instructions, procedures, and dratrings, including clunges thereto, which prescribe all activities affecting quality.
Changes in any of these documents require authorized approval and records of these changcc are maintained. A stepwlso sequence for making changes is available which provides a recorded date for the chant;e, a revised docunent uith the change, and replacement of all prorovision documents.
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o 12 The FBF criteria as part of a; quality assuranco program are:
The review, approval, and issue of documents (such as listed in a.
item h below) and changes thereto, orlor to release, are procedurally controlled.to assure they are adequate *and the quality requirements are
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b.
Provisions are established which identify those individuals or groues resoonsible for reviewing, approving, and issuing documents and revisions thereto.
Changes to documents are reviewed and approved by the same c.
personnel that oerformed the original review and nooroval.
d.
Aooroved changes are included in instructions, orocedures, drawings, and other documents orlor to implementation of the change.
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Obsolete or superseded documents are controlled to prevent e.
inadvertent use, s
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Documents are available at the location where the activity will be performed orlor to commencing t'he work.
g.
A master list is established to identify the current revision number of instructions, procedures, speelfications, drawings, and procurement
~ documents. This list is updated and distributed to oredetermined, responsible
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personnel to preclude use of superseded documents.
h.
The documents that are controlled under this subsection are identified. 'They include;
.i (1) Design specifications.
(2) Design, manufacturing, construction, and installation drawings.
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(5) Operating, maintenance, and modification procedures.
(6) Manufacturing, insoection, and testing instructions.
(7) Test procedures.
(8) -Design change requests.
(9) Nonconformance reports.
(See Appendix 6-1 Document Control)
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.(7) Control of Purchased Materials, Parts and Components Incoming insocetions are performed on ourchased materials, parts, and components to. cnsure that they conform to procurement documents, certifications,.and soecifications.
The FBF critoria as part of a quality assurance program are:
Qualified oorsonnel evaluate the suoolier's capability to provide a.
acceptable quality services and products.
The QA and engineering ocoole particloate in the evaluation of those supo11ers providing critical components.
b.
The evaluation of supo11ers is based on one or more of the following:
-(1) The sunoller's capability to comply with the elements of Appendix E to CFR Part 71 that are applicable to the tyoc of material, equipment, or service being procured.
(2) A review of previous records and oerformance of suoollers who have orovided similar articles of the tyoc being procured.
j (3) A survey of the supol ter's f acilities and QA program to determine his caosbility to supply a oroduct which meets the design, manu-i facturing, and quality requirements.
'c.
The results of sunoller evaluations are documented and filed.
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'O 14 d.-. Surveillance if required, of suppliers durin g fabrication insoec-tion testing, ~and'shloment of materials, equipment, and components is planned-and performed in accordance with written orocedures to assure.
4 conformance,to the purchase order requirements.
These orocedures provide for:
'(1)
Instructions that specify the characteristics or processes to-be witnessed, inspected or. vert fled, and accepted; the method of sur-vel 11ance and the extent of documentation required; and those responsible for implementing these instructions.
(2) -Audits and surveillance which assure that the supplier como11es with the cuality requirements.
Surveillance is performed on those items where verification of procurement requirements cannot be determined j
upon recelot.
The. supplier furnishes the following records as a minimum to FBF.
e.
(1) Documentation that identifies the ourchased material or equipment and the specific procurement requirements (e.g., codes, standards, and sperifications) met by the items.
(2) Documentation that identifies any procurement requirgments which have not been met together with a descriotion of those nonconformances disoositioned " accept as is" or HreDaIT."
The review and acceptance of these documents are described in the FBF OA program and as a minimum shall be undertaken by a responsible QA Individual.
2 f., Suooller's certificates'of conformance are oeriodically evaluated by audits, independent inspections, or tests to assure they are valid.
Receiving inspection of 'the supplier-furnished material, equipment,
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- and services is performed to assuret i
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-(1)..The material', comoonent, or equipment is properly identified and corresponds with the identification on receiving documentation.
(2) Material, comoonents, couloments, and acccotance records are
' inspected and judged acceptable in accordance with predetermined inspection instructionsi orlor to installation or use.
(3)
Inspection records or-certificates of conformance attesting to s
the acceptance of material and components are available orlor to installa.
tion or use.
(4)
Items accepted and released are identified as to their inspec.
t tion status orlor to forwarding them to a controlled storage area or releasing them for further work.
h.
The effectiveness of. the control of quality by supo11ers is assessed by the soolicant at intervals consistent with the importance, complexity, and quantity of the item.
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Soare or reolacement oarts of safety-related systems and compon-ents are subject to controls at least equivalent to those used for the original eouloment.
(See Appendix 7-1 Supplieg Qualits-Evaluation)
R-1 (8) Identification and Control of Materials, Parts, and Components 7/1/78 FBF takes measures by tagging or stamping to assume proper identification and control' of materials, parts, and components, including partially fabricated assemblies.. These neasures assure that identification is maintained, either on the package or on records traceable to the package, throughout fabrication, assembly,. installation, repair, or modification. The measures are designed to prevent the use of incorrect or defective parts, and parts
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Raw material may-require certification.
Overrun stock control may te required, and proper identification, storage, and re-inspection procedures should be used in these cases.
Part' numbers and lot numbers.are used, if applicable.
The FBF. criteria as part of a-quality assurance program are:
-Procedures are established to identify and control materials, a.
parts, and comoonents including partially fabricated subassemblies.
.b.
Identification requirements are determined during generation of specifications and design drawings.
c.
The identification and control procedures assure that identifica-tion is maintained either on the item or on records traceable to the item t
to preclude use of incorrect or defective items.
d.
Identification of materials and parts important to the function of safety-related systems and components can be traced to the aooropriate
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documentation such as drawings, specifications, purchase orders, manuf actur-ing and inspection documents, deviation reports, and physical and chemical mitt test reports.
e.
The location and the method of identification do not af fect the fit, function, or quality of the item being identified.
f.
Correct identification of material, parts, and components is veri-fled and documented prior to release for fabrication, assembling and installation.
t (See Appendix 8 1. Identification and Control of Materials, Parts and Components R-1 a
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~(9) Control of Soecial Processes.
.7/1/78 Measures should be established to assure that special processes,-
including welding, heat treating. and nondestructive testing, are controlled in accordance with applicable codes, standards, soecifications, criteria, and~other special requirements, and are accomplished by qualified oersonnel using approved procedures.
Soecial orocesses may be develooed for specific packages by manufacturers and the control of and results from these processes should be documented.
The FBF criteria as part of a quality assurance program are:
a.
Speelat processes such as welding, heat treating, nondestructive testing, and cleaning are procedurally controlled.
b.
Procedures, equipment, and personnel connected with sepelat processes are qualified in accordance with appilcable codes, standards, and soecifications.
c.
Soecial orocesses are performed by quallfled oersonnel and accomplished in accordance with writtet orocess sheets or eculvalent with recorded evidence of verification.
d.
Qualification records
'f procedures, couloment, and personnel associated with special proc. 9es are established, flied,~and kcot current.
(See Apocndix 9-1 Sc1 ding Procedure; 9-1A Heat Treating; 9-1B Non-Destructivo R-1!
l Testing: Magnetic Particle Test, Dye Penetrant test, IIalogen Gas Test) l (10)
Inspection 7/1/78 I
A program for receiving,'in-process, and final inspection of activities i
affecting quality have been established to assure conformance with documented instructions, orocedures, and drawings.
D(aminations, measurement, or l
tests of material or products processed is performed for each work I
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.e 18 ooeration where necessary to assure _ quality.
If insoection of proce'ssed material or oroducts is impossible or disadvantagevus, indirect control by.
monitoring processing methods, equipment, and personnel is provided.
Both inspection and process monitoring is provided when control is inade-quate without.both. Mandatory inspection hold.coints, which require witnessing or insoccting by the designated representative and beyond which work should not proceed without the consent of'that reoresentative, must be established.
The primary purpose of receiving inspection is to determine compliance or non-compliance of all material, parts, and processes with all applicable drawings, toecifications, ourchase orders, and contractual requirements.
t.t so, it is the resoonsibility of receiving inspection to maintain con-tinuous control of accepted parts and materials untti they are placed into stock er inventory for routine use, and of rejected oarts and materials until they are disoosed of in accordance with procedures.
Rejection reports, discrepancy reports, foll'ow-up on vendor corrective action, and/or vendor process caonbility trends may be reautred for particular packages.
In-process inspection should provide adeounte control over manu.
facturing procedures, while final insoection should be designed to ell-minate all non-acceotabic packages or procedures.
The FBF criteria na part of a quality assuranco program are:
An insocction orogram which vertfles conformance of ouality-a.
affecting activities with requirements is established, documented, and
-accomo!!shed in accordance with written and controlled procedures, b.
Insocction personnel are indeoendent from the individuals per-forming the activity _being inspected.
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- 19 c.
Inspection procedures, instructions, and check lists provide for the following:
(1)~ Identification of characteristics and activities to be inspected.
(2)
Identification of the individual (s) responsible for oer-forming the inspection operation.
(3) Acceptance and rejection criterla.
(4) A description of the method of inspection.
(5) Recording evidence of comoteting and verifying a manu-facturing, inspection, or test operation.
(6) Recording inspector and the results of the insoection i
operation.
(7) Approval of data by manager of QA.
d.
Inspection procedures or instructions are used with necessary drawings and specifications when oerforming inspection operations.
Inspectors are quallfled in accordance with applicabic codes, e.
standards, and company training programs; and their qualifications and certifications are kent current.
f.
Modifications, repairs, and replacements are insoccted in accordance with the original design and inspection recuirements or acccot-2 able alternatives.
g.
Provisions are established that identify mandatory inspection hold points for witness by an insoector, h.
The individual (s) who perform receiving and process verification insocctions are identified and shown to have sufficient independence and 4
qualifications.
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20 1.
Provisions are established for indirect control by. monitoring processing methods, equipment, and personnel if direct inspection is not possible.
(See Aooendix 10-1 Quality Control Check-Off Sheet (Inspection).
R-1 (11) Test control 7/1/78 A test control orogram has been established to assure that all required testing, including proof testing, acecotance testing, and opera-tional testing, is identified ~ and performed in accordance with written test procedures which incorporate the requirements and acceptance limits contained in aoolicable design documents.
The test procedures include provisions for assuring that all preregulsites for the given tests have been met, that adequate instrumentation is available and used, and that the test is performed under suitable environmental conditions. Test
-results are documented and evaluated to assure that test requirements have been satisfied.
Test procedures are imolemented and controlled by defining the exact procedure.
The FBF critoria as part of a quality assurance program are:
a.
A test program to demonstrate that the item or component will perform satisfactorily in service is established, documented, and accomp-11shed in accordance with written controlled procedures.
b.
Modifications, repairs, and replacements are tested in accordance with specifications.
c.
Written test procedures incorporate or reference:
(1) The requirements and acceptance limits contained in apoll-u\\
cable specifications.
- _ o -
=
21 (2)
Instructions for performing the test.
(3) ' Test prerecuisites_such as:
Calibrated instrumentation.
. Adequate and appropriate equioment.
Trained, qua11 fled, and licensed or certifled personnel.
Completeness of item to be tested.
Sultable and controlled environmental-conditions.
Provisions for data collection and storage.
(4) !!andatory inspection hold oolnts for witness by responsible individual.
(5) Acceotance and rejection criteria.
(6) Methods of documenting or recording test data and results.
d.
Test results are documented, evaluated, and their acceptability determined by a cualified, responsible Individual, and by the manager of QA R-1 (See Apoendis 11-1 QC - Check-Off Sheet. (Testing).
R-1 t
(12) Control of Measuring and Test Equipment 7/1/78 FBF has established measures to assure that tools, gauges, instru-ments, and other measuring and testing devices used in activities affecting quality are cattbrated and properly adjusted at specified periods to maintain accuracy within necessary limits. Where possible, calibration are against verified measurement standards which have known valid relation-ships to national standards. Only calibration devices and tools that have been identified, and have current calibration should be used.
Any of these items'are properly stored when not in use.
.e I
22 The FBF critoria as part of a-quality assurance program are:
a.
Provisions, contained in orncedures, describe the calibration-technique and frequency, maintenance, and control of the measuring and
' test equipment (instruments, tools, gauges,- fixtures, reference and transfer standards, and nondestructive test equipment) which is used in the measure-ment, insoection, and monitoring of safety-related comoonents and systems.
b.
Measuring and test equipment is identified and traceable to the calibration test data, I
c.-
Measuring and test equipment is labeled or tagged to indicate date of the next. calibration.
'd.
Measuring and test instruments are calibrated at specified Intervals based on the required accuracy, purpose, degree of usage, sta-bility characteristics, and other conditions affecting the measurement.
e.
Measures are taken and documented to determine the validity of previous inspections performed when measuring and test equioment is found to be out of calibration.
f.
Calibrating standards have an uncertainty (error) requirement of no more than 1/4th of the tolerance of the equipment being calibrated.
A greater uncertainty may be acceptable when limited by the " state-of-the-art."
g.
The complete status of all items under the calibration system is rec.
ed and maintained.
h.
Reference and transfer standards are traceable to nationally recognized standards.
l(See Appendix 12 1 ' Equipment Testing and Calibrating: 111croneters).
R-1
23 (13) Handling, Storage, and Shipping 7/1/78 Work and inspection instructions for handling, storage, shinoing and preservation of material and equipment to orevent damage or deterioration is provided. When necessary for any particular product (s), special pro-tection environments;'such as, inert gas atmos'pheres, specific moisture content levels, and temperature levels, are provided and their existence verified.
Shloments are not made unless all certifications, test reports, markings, and accentances are available.
The FBF criteria as part of a quality assuranco program which' apply to handling, storage and shiooing are:
Special handling, oresentation, storage, cleaning, packaging, a..
and shipping requirements are established and accomolished by qualified individual (s) in accordance with predetermined work and inspection instruc-tions.
b.
Procedures are prepared which control the cleaning, handling, storage, packaging, shipping, and preservation of materials, components, and systems in accordance with design and specification requirements to preclude damage, loss or deterioration by environmental conditions such as temperature or humidity.
Tho' FBF criteria as part of a quality assurance program which apply only to nanufacture of containcra for une in shipning of approved nackages are:
a.
All conditions (operations, tests, inspections, specifications, etc.)[ofthellRC[FBF,Inc.manufacturedportionof)packageapprovaland tho_U.S.DepartmentofTransportationshippinghontaineronlyconstructich requirements must be satisfied.
- .rf...
24 b.
All necessary shlooing anoers prepared as reoutred..
. Departure, arrival time and destination of (h newly manufactured c.
container portion o5f package should be established and monitored to a degree consistent with the safe transoortation of the package.
(Note: The user
~or Licensee of osckage is resoonsible for the total shipping onckage.)'
~
(See Aooendix 13-1 Control of cleaning, handling, storage, packing, shipping, R-1 and preservation of materials).
(14)
Inspection Test and Operating Status 7/1/78 Markings such as stamos, tags, labels, routing cards, or other suitable means, are used to indicate the status of inspections and tests performed upon individual items and the status of onekages or equipment.
Items which conform to inspection and test requirements are identifiedi noncon-t forming items are clearly marked for subsequent disposition.
The FBF critoriaas part of a quality assurance progran are:
a.
Identification of the inspection, test, and operating status of onckages and components is known by affected organizations.
b.
The apolication and removal of inspection and welding stamos and status. indicators such as tags, markings, labels, and stamos are proced-urally controlled.
c.
Bypassing of required inspections, tests, and other critical i
operations is procedurally controlled under the cognizance of the QA nanager.
I d.
The status of nonconforming, inoperative, or malfunctioning packages or components is identified to prevent inadvertent use.
(
(See Appendix 1 Identification Tags,14arkings, and labels for Control R-1 of ' Inspection Tests and Operating Status.
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.1 26
((15),Ilon-Conforming thterial, Parts, or Components 7/V78 lhterial, parts, or components'which do not' conform to requirements are control'.cd to prevent their inadvertent use or installation. Pro-
- cedures have been established for identification, documentation, segregation,
. disposition, and notification to affected personnel or organizations. lion-conform-ing items are revicued and accepted, rejected,. repaired, or reworked in accordance with documented procedures. Ultimato disposition of non-conforming items must be' documented.
Prc,cedurcs are established for segre ation, identification, removal, and disposal _of all non-conforming material. Ihterials or r, arts nay not be used when a discrepancy occurs which is likely to_ affect the form, fit, or function _of the final item with respect to safety.
The FDF critoria as part of a quality assurance program are:
The identification, documentation, segregation, review, disposition, a.
and notification to affected personnel or organizations of non-conforming materials, parts, components, or services are procedurally controlled. The manager R-1 of QA has responsibility and authority for the disposition and approval of' non-conforming items. The Tresident of FBF, Inc. over-vicus the actions of the QA manager to assure full compliance with Appendix E to 10 CFR Part 71.
b.
Documentation identifies the non-conforming item; describes the non-conformance, the disposition of the ncn-conformance, and the -inspection requirements; and includes signature approval of the manager of GA for disposition.
Provisions are established identifying those individual (s) (manager of Rt c.
QA and the President of.FBF, Inc.) delegated the responsibility and authority 1
for'the' disposition and approval of non-conforming items.
- d..Ilon-conforming items are segregated from acceptable items and identified as discrepant until properly dispositioned.
i
- 4..
26 Acceptability of rework or reonir of materials, oarts,'comoonents e.'
and systems-is verified tur reinspecting and retesting the item as origina-11y inspected and tested or by a method which is at least equal to the original inspection and testing method.
Insoection, testing, rework, and repair procedures are documented.
f.
Nonconformance reports dispositioned " accept as is" or " repair" are made'-part of the inspection records.
'g. Nonconformance reoorts are oeriodically analyzed to show quality
. trends, and the results are reported to management for review and assessment.
(See Appendix 15-1 Non-Conforming 14aterials).
R-1 (16) Corrective Action 7/1/78 Conditions adverse to cuality, such as failures, malfunctions, deft-ciencies,-deviations, defective material and equipment, and non-conformances, are promotly identified and reported to aooroorlate levels of management.
The cause of the condition adverse to quality are determined and corrected to preclude renetition. The corrective action measures extend to the performance of all supollers and subcontractors as necessary.
The identi-fication of conditions adverse to quality, the cause of the condition, and the corrective action taken is documented.
All corrective action is followed-uo for the ourpose of checking the results of the action.
Documented results provide management with the means of assessing any corrective actions.
The FBF criteria as part of a quality ancuranco program are:
a.
Evaluation of conditions adverse to quality (such as nonconfor-mances, failures, malfunctions, deficiencies, deviations, and defective material aru$ equipment). is conducted to determine the need for corrective action in accordance with established orocedures.
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- b. - Corrective action in-initiated by the nanager of QA following the.
R-1 deternination of a condition adverse to quality to preclude recurrence.
Follow-up reviews are conducted b'y the President of;FDF, Inc. to c.
verify prot,cr implementation of corrective actions and to 'close out the ccrrective action documentation.
d.
Significant conditions adverse to quality, the cause of the conditions, and the correctivo action taken are reported to cognizant levels of nanagement for review and assessment.
. (See Appendix 16-1 Corrective Action Reports).
'R-1 (17) Quality-Assurance Records 7/1/78 Sufficient records are maintained to furnish documentiry evidence of activities affecting quality for use in the management of the program.
The records include work papers and the results of revious, inspections, tests, audits, nonitoring of work performance, and materials analysco. The records also include closely related data such as qualifications of personnel, procedures, and equipment.
Inspection and test records, identify the inspector, the type of observation, the results, the acceptability, and the action taken in connection uith any deficiencies noted. Consistent uith applicable regulatory requirencnts, the FBF has established requirements concerning record rotention, such as duration, location, and assigned recponsibility. The specific location of all quality assurance records is at the plant office, oren for inspection R1 or recall at any timo, and well secured in a fire, water, and burglar-proof vault.
The FBF criteria as part of a quality assuranco program are:
Sufficient records are naintained to provide documentary evidence a.
of the Lquality and safety of items and the activities affecting quality and safety.
1
8
_-o o_
28 b.- QA records include work papers, logs; results of reviews, inspec-tions, tests, audits, nnd material analyses; monitoring of work perfor-mance; qualification of perso-nel, procedures, and equipment; and other documentation such as drawings, soecifications, procurement documents, calibration orocedures (where required) and reports; nonconformance reports; and corrective action reports. The QA records are grouped together for case of' reference.
c.
Records are identlftable and retrievable.
d.
Requirements and responsibilities for record transmittals, retention (such as duration, location, fire protection, and assigned responsibilities), and maintenance subsequent to completion of work are consistent with nonlicable codes, standards, end procurement documents.
e.
Inspection and test records contain the following where app 11-cable:
(1) A descriotion of the type of observation (2)
Evidence of comolet'ing and verifying a manufacturing, inspection, or test operation.
(3) The date and results of the inspection or test.
(4)
Information related to conditions adverse to quality.
(5)
Inspector or data recorder identification.
(6) Evidence as to the acceptability of the results.
f.
Record storage facility in a vault, located, and secured R-1 to prevent destruction or deterioration by environmental conditions.
(See Apoendix 17-1 QA Records Rotention, Duration, Locations and Respo'sibility).
R-1 n
29 (18) Audits 7/1/78-Quality assurance audits are required to verify compliance with all aspects of the quality assurance program and to determine.the effectiveness of the program. A system of planned and periodle audits exists to estabitsh the results of a quality assurance program. and to provide a means of reviewing that program.
The FBF criteria as part of a quality assurance progran are:
Audits are performed in accordance with orcestablished written a.
procedures or check lists and conducted by trained personnel not having direct responsibilities in the-areas being audited, b.
Audit results are documented and then reviewed with management having responsibility in the area audited.
The President of FBF, Inc. takes the necessary action to correct the R-1 c.
defielencies revealed by the audit.
d.
Deficient areas are reaudited on.a timely basis to verify imple-mentation of corrective actions which minimize recurrence of deficiencies.
Audits include an objective evaluation of quality-related oractices, e.
procedures, and instructions and the effectiveness of implementation.
f.
Audits include the objective evaluation of work areas, activi-ties, processes, and items, and the review of documents and records.
Audits to assure that procedures and activities are meaningful g.
and comoly with the overall QA program are performed, insofar as possible, by:
(1) -The OA nanager, to provide a comprehensive independent vertiteation and evatustion of quality-related orocedures and activities.
O 30 (2) FBF and principal contractors, to verify and
-evaluate their suopliers' QA programs, orocedures, and activities.
h.
Provisions are established requiring that audits be oerformed in
'those areas where the requirements of Aooendix ? to 10 CFR Part 71 are being imolemented.. These areas shall include those safety-related activi-ties associated with:
(1) Modification and reoair of packages (use and maintenance are not apolicable).
(2) The orcoaration, review, nooroval, and control of designs, specifications, procurement documents, instructions, orocedures, and drawings.
(3) Receiving insoections.
(4) Training programs.
(5) The implementation of test procedures.
(6) Calibration of measuring and testing equioment.
1.
Audits are regularly scheduled on the basis of the status and safety import'ance of the activities being performed and are initiated eart) enough to provide effective quality assurance during the design.
procurement, and contracting activities.
J.
Audit data are analyzed and the reports, which indicate cuality trends and the ef fectiveness of the QA program, are reported to the President of R-1 FDF, Inc. for review and assessment.
(See Aooendix 18-1 Audits: Work Arcas, Activitics, Processes, Items and R-1 l Review of Documents and Records).
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REFERENCES 1.
Title 10, Code of Federal Regulations, Part 71, " Packaging of Radio-active Materlat for Transoort and Transportation of Radioactive Material Under Certain Conditions," Superlntendent of Documents,
~
U. S. Government Printing Office, Washington, D. C.
2.
Title 49, Code of Federal Regulations, Parts 171 through 179 Harardous Materials Regulations, Superintendent of Documents, U. S. Government Printing Office, Washington, D. C.
3.
~ Ducan, A.
J., Ouality Control and Industrial Statistics, 4th ed.,
Richard D. Irwin, Inc., Homewood, Illinois, 1974 4.
J. H. Juran and F. M. Gryna, " Quality Planning and Analysis,"
McGraw-Hill Book Comoany, New York, N.
Y.,
1970 5.
J. M. Juran (ed. ), " Quality Control Handbook," 3rd ed., McGraw-Hill Book Company, New York, N.
Y.,
1974.
6.
American National Standards Institute, " Quality Assurance Prcgram Requirements for Nuclear Power Plants," ANSI N45.2-1971, New York, N.
Y.,
1971.
7 American National Standards Institute, " Quality Assurance Terms and
)
Definitions," ANSI N45.2.10-1973, New York, N.
Y.,
1973.
i l
APPEliDIX A o,
F a f'O 1 of 5 CLossAgy 0F TEans As used in this specification, the following terms shall mean:
ACCEPTANCE CRITERIA The limit, or limits, associate.d with established values, used to /etermine whether or not an item is satisfactory.
ADMINISTRATIVE PROCEDf!RE A document that speelfle:s or describes an activity in terms d9 noting:
(1) What activity is to be oer'.ormed; (2) Who is responsible for the activity; (3) When the activity will be ocrformed; and (4) How the activity will be accomolished (sequence of events).
APPROVAL The act of endorsing or assigning positive authorizatten, or both.
ASSEMBLY A combination of subassemblies or comoo-nents or both fitted.together to form a unit.
AUDIT An activity to determine through investi-gation, the adecuacy of, and adherence to, established procedures, specifle'a-tions, codes and procurement document requirements, and the effectiveness of implementation.
CERTIFICATE OF CONFORMANCE A written sentement exolleitly stating what items are certified, signed and dated by a qualified party, identifying the controlling acceptance standards utilized and attesting that the items or services meet all the specified require-ments of the procurement documents.
CERTIFICATION The action of determining, verifying, and attesting in writing to the cualifications of personnel or material.
CHARACTERISTIC A physical, chemical, visual, functional, or other ident ifiable property of an item, process or service.
COMPONENT A piece of equipment, such as a vessel, ntning, oumo, valve, core sunoort strue.
ture, etc., which may be combined with other components to form an assembly.
ISSUE DATE:
7/1/78 PAGE 1 SERIAL QA4
};,
GLOSSARY OF TERNS (enntinusd)
Appendiy A Fve 2.vf ~
, DOCUMENT Any writtsn or onctorial Information' des.
cribing, defining, soccifying,~ reporting, or certifying activities, requirements, orocedures, or results.
DOCUMENTATION A comollation of those documents'concerning a specific function, activity, or oroject.
EX AMINATION An element of insocetion consisting of Investigation of materials, comoonents, suoolies, or services to determine conform.
ance_to those soccified requirements which can be determinod by such investigations.
Examination is usually nondestructive and includes visual, simole ohysical mantoulation, i
gaging, measurement and written documentation.
HANDLING An act of physically moving and/or lifting items by hand or mechanical means.
INSPECTION A ohase of ouality control which by means of examination, observation or measure.
i ment determines the conformance of items, l
orocesses, or services to oredetermined requirements.
Insocction may involve the use of soecial equioment tools, procedures or documentation.
INSPECTOR A quallfled Individual employed by the (SUPPLIER)
Supoller whose duties include verification of quality related activities and who is independent of the activity being verified.
INSPECTOR A quallfled individual employed by FBF Inc.
, whose duties include verification of Suo.
olier's conformance to the requirements of the orocurement documents.
1 ITEM Any level of unit assembly, including i
system, subsystem, subassembly, component l
or material.
MATERIAL A substance or combination of substances used to form oleecs, onrts, components, items, etc. (including machinery, metal shaocs, plates, castings, forgings aggregates, cements, liquids, etc.).
ISSUE DATE:
7/1/78 PAGE 2 SERIAL QA4
GLOSSARY OF TERMS _(esntinued p[erulix A Pufe 3 Of 5 NONCONFORMANCE-A drficicney in characterist ic, documen-tation', performance or procedure which renders the cuality of an item unacceptable or indeterminate.
Examples of nonconform-ances include:
ohysical defects, test
~
failures, incorreet'or inadequate documen-tation; or deviation from design standards, prescribed processing, inspection or test procedures, and procurement document require-ments.
OBJECTIVE EVIDENCE Any statement of fact, information, or record; either quantitative or qualitative certaining.to the cuality of an item or service whleh can be vertfled by records of test, examinations, inspections measure-ments, or observations.
PART
'An item which has work performed on it and which is attached to, and becomes an element of a component PROCEDURE A document which soccifies instructions for ocrformance of a particular task.
It includes methods to be employed, descrio-tion of equipment, or material to be used, secuence of operations, etc.
a PROCESS One or more operations, methods, funettons, procedures, or other specified actions, which result in the desired end item or 4
result.
PROCUREMENT DOCUMENT A contractually binding document, including attachments, identifying the requirements which items or services must meet ortor to e
acceptance. Also includes purchase requi-sitions.
QUALIFICATION A demonstration of those characteristics or (PERSONNEL) abilities of an individual, gained through training and/or exoerlence, that enable him to perform specific functions.
QUALIFIED EQUIPMENT Eculoment which has been evaluated by sufft-cient testing to assure performance within specified parameters.
QUALIFIED PARTY OR A ocrson or organization comoetent and ree-INDIVIDUAL ognized as knowledgeable to perform certain functions.
QUALIFIED PROCEDURE A procedure which incoroorates all nonlicable code and standard requirements, manufacturing onrameters and engineering specifications, and which has been oroven adequate for the intended purpose.
4 4
_ ISSUE' DATE:
7/1/78 PAGE 3 SERIAL QA4
.e GLOSSARY OF TERHS (continuid) e Ap endiy A P-re 4'of 5 QUALITY The oroperties or characteristics, constituting those requisites of specifi-cations, codes, standards, industrial practices, other recognized methods and/or aceeotance criteria, by which an item is
-Judged.
QUALITY ASSURANCE All those olanned and systematic actions,
~
including quality administration and quality control, which orovide adequate confidence that an item or facility will perform satisf actorily in service.
QUALITY CONTROL Those qual'ity assurance actions which oro-vide a means to control the characteristics of an item, orocess or f acility to estab-Ilshed recuirements.
QUALITY REQUIREMENTS MATRIX (QRM)
A document supolled with the FBF orocure-ment documents. The ORM is a summary of the cuality requirements as defined in the FBF specifications.
'It identifies the sucoller documentation to be submitted to FSF during the performance of the order and the suooller documentation to be included in the OA data onekage at the completion of the order.
It also designates the noolicable sections of this soecification.
REPAIR The process of restoring a nonconforming characteristic to a condition such that the capability of an item to function reliably and safely is unimpaired, even though the item still may not conform to the original requirement in every asocet.
REWORK The process by which a nonconforming item is made to conform to a orlor soccified requirement by completion, remachining, reassembling, or other remedial means.
(Cutting off excess metal is rework; welding on an extension is repair.)
SCRAP' A disoosition which may be imoosed upon a nonconforming item when it has been established that the discrepancy renders the item unfit for its intended use and it is not economically or otherwise feasible to repair or rework it.
Serno may also be excess material, or damaged ISSUE DATE 7/1/78 PACE 4 SERIAL QA4
'v, Fendix A Iare 5 of 5 GLOSSARY OF TERMS (centinusd) material, remaining from fabrication operations which is unsultable for further use.
SOURCE INSPECTION A review, observation, or inspection a-the ouroose of verifying that an action has been accomolished as specified at the location of procurement or manufacture.
SUBSYSTEM A group of assemb11ed, comoonent s, or both, combined to perform as an element of a system.
SUPPLIER Any organization under contract for fur-nishing items or services.
It includes the terms vendor, contractor, subcontrac-tor, fabricator, organizations internal to FBF, and subtier levels of these where sooroorlate.
SYSTEM A group of subsystems, or subassemblies united for the ourpose of perf orming one or more duties while functioning as a single unit.
USE-AS-IS A disoosition which may be imposed upon nonconforming items when it has been established that the discreoancy does not affect the intended use and that the item will conform to functional requirements.
VERIFICATION The act of confirming, substantiating, and/or assuring that an action has been performed or a condition achieved in conformance with specified reautrements.
6 ISSUE DATE 7/1/78 PAGE 5 SERIAL QA4 j
- N 4 %4L) l
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- J; * -
APPENDIX 1-1
.FBF, Inc.
Qualifications of QA Manager
. The Q.1 manager must possess a working knowledge of quality assurance and have had
. n minimum of 10 years experience in the QA-QC field. He must possi.ss special skills and knowledge in calibration procedures, applicable codes,: standards, procurement-regulations,. interpretation of drawings, specifications, material analysis, monitoring ef work performance, loging, _- reporting and reviewing QC findings in inspections, tests Jand audits. He must display courteous,.yet firm, attitude in administering the QA program, and assure a high quality product that fully meets the customer specifications.
D 84M y l
l 155700
)
APPENDIX 1-la i
F3F, INC.
0A PROGRAM - ORGANIZATION CHART President t
- (
Plant Manager Quality Assurance Manuf acturine Minaner lSta f f Funet tons:l
--." Cutting &
iProceduresl
"-doesign Eng ineerind '
Threadine 2-R's hieldine shod
"-10ua l i ty Control l
" 1Procuremend Insulation Cutting 5 Preoaration Soecial &
'--13usiness Offled
" 7Cleanine &Ceerensinel
' " jPa int inel
"-1Labelinrl iAs semblyl Insoect ion Testing 4
deceiving Shionine _
Warehousine Storace
APPDIDIX 1-1 B -
FPE, Inc.
QA Program - Functienal Clutrt President Qt,1i ty Assuranco Manager On-Site Off-3ite Functions-QC Functions-QC.
M Ihnufacturing l
Design rhgineering H
Inspecting l Connonent Fabrication Testing Procurenent Procurement l
In.:pecting H
Procedures Testing
r
..e APFE:NDIX 1-10 Page 1 of 2 FBF, Inc.
QA Program - QC Control QA Responsibilities and Interface Relationships On-Site Functions and Off-Site Functions
. Manufacturing:
The QA manager is responsible for quality control in all phases of manufacturing, which currently includes:
1.
Cubting, sizing, threading of 2-R's 2.
Cutting,. sizing and preparation of insulation 3
Cleaning and degreasing operations h.
Wolding and grinding 5.
I/tbeling 6.
Assembling 7.
Inspecting 8.
Testing 9.
Painting
- 10. Packing
- 11. Shipping
- 12. Receiving 13
'brehousing and storage IIany of the above functions reauire special equipment such as nicrometers, thread gauges, tenplets, jigs, fixtures, vacuum equipnent, leak detectors, ultra-sonic testors, pressure and vacuun gauges, etc., in determining if nanufactured components meet print specifications. The QA manager has full responsibility to see that cach part or component ncet the specifications or else label them non-conforning and separate the rejects for future re-work or discard"to scrap.
Inspecting:
The Qk manager is responsible for inspecting all items manufactured and to 1
determinc that they ncet specifications at cach station in the nanufacturing process before permitting then to pass to the next stago in the process. Quality parts and components arc decacd to be vital in the nanufacture of containers and the QA manager has complete authority to stop any process or part at any time quality standards are not net. Full cooperation along this line is required and the lYoduction Superintendent as well as the forenan and equipment operators fully understand this important aspect of quality operations. This type inspection applies whether or not the inspections are performed by_the FIIF, Inc. QA nembers or by an outside independent qualified inspector.
Independent inspect ors qualified to SUT-TC-IA are of ten used for certified inspections to code when required by the customer.
Testing:
Most certified testing required by customers is perforned by an outsido independent technician qualified to SHT-TC-IA and performs the tests to specified code, eg: ASME or ASTM, etc. The cooperation of nll personnel in the manufacturing, procurement, design engineering, and any other affected organizational units is reouired. The QA manager handling or coordinating the testing has full authority to stop or remove for L
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~ Page 2 of 2 1-10
. rework or discard _to cerap any part or unit that fails to pass tho test (s). In those instances uhcre the QA nanager conducts tests to the D0f and customer specifications, the full cooperation of all levels of organization is required and the QA nanager has full authority to stop work or remove itens for rework or discard to aerap.
Procurement:
The QA manager deternines that the materials or components ordered nect the specificationc - first by checking the purchase order -(after evaluating the vendor for quality performance) secondly, by inspecting the material or components upon receipt at FBF, Inc. The itens are narked or tagged for control throughout the manufacturing process. The Q.A manager has full control in matters portaining to quality and has cuthority to stop any procurenent' or return as unacceptabic any iten not meeting the specifications.- The full cooperation of the Purchasing Department, Receiving Department and Vendor is required in these acquisitions.
Procedure:
Tho QA manager regularly revieus the procedures for compliance with the requirements of Appendix E to 10 CFR Part 71; revises the procedures if needed, and audits the procedure for full compliance at regular intervals. The President of FBF, Inc.
over-views the procedurcs and audits to assure they are in conformance with Appendix E, and uorking snoothly to accure a high quality product. Again, the cooperation of the entire organization, both within and between organizational units, is required by the President of FBF, Inc.
Design Engineering:
Lost of the design engineering required is performed by competent censultants to FBF, Inc. since practically all of the containers manufactured are built to DOT specifications. Houever, when design engineering is required, the expertice is usually obtained by contract from om of the major Uuclear Inatallations in Oak Ridge.
The President of FBF, Inc. ucually coordinates the design uork uith the consultants and affected FBF, Inc. department nanagers. Conplete cooperation is alrays achieved. The QA manager follous the design very cloccly and contributes to assure full compliance with Appendix E to 10 CFR Tart 71.
l e
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s APPENDIX 2-1 FBF, Inc.
Sunmary cf QA Policies, Goals and. Objectives
-It is the policy of FBF, Inc. to emphasize:
- 1) The importance of quality, quality attitudes and acceptance of individual responsibility for achieving quality work.
-2) To recognize the role of quality assurance in achieving quality objectives..
- 3) 'To train employees in quality workmanship.
h) To produce a high quality product, safely and efficiently according
.to applicable specifications and codes.
The goals of FBF, Inc. in quality assurance are to:
- 1) Train employees to perform and recognize quality work.
- 2) To perform the work correctly the first time.
- 3) To cooperate and help in identifying quality with the proper attitude toward quality assurance.
h) To achieve quality parts and components for a high quality product I
that will perform safely and efficiently.
It is the objective of FDF, Inc. to meet the applicable specifications, codes and standards using well trained and highly qualified, competent personnel to produce a safety-orientated quality prodtiet manufactured in full compliance with Appendix E to 10 CFR Part 71 and the customer's QA, drawings and specifications.
s
)
1 1
- y APPDIDIX 2-1 A Page 1 of h FBF, Inc.
- QA Procedures + lhtrix Cross Referenced to Criterion of Appendix E to 10 CFR Part 71 QA Procedures 1htrix X-Referenced' to Critorion of Appendix E
- 1). Organization
~ l a.
Responsibility for QA program retaine'd and exercised by FBF, Inc.
.1 b. - QA/QC identified, described and provide control per ADrendix: E 1 c.
Clear and effective lines of communication catablished to assure direction of QA program and resolution of QA problems 1 d.
Organization chart identify elements under control of OA program 1 e.
Interface relationships & QA responsibilities described & demonstrate assignnent of responsibilities for Anpendix E Appendices: 1-1 Qualifications of QA Ifanager 1-1A QA Organization Chart 1-1B QA Functional Chart 1-10 QA Responsibilitics & Interface Relationships
- 2) Quality Assuranco Program' Appendices:
2-1 Brief sunnary of FBF, Inc.
QA policies, goals and objectives; 2-1A matrix of QA procedures referenced to critorion of Appendix E to 10 CFR 71; 2-1B Safety related systems, structures and conponents controlled by QA program; 2-1C_ Resolution of disputes involving' quality - between G /QC personnel and other departments.
- 3) Design control 3 a.
Itcasures are established to carry out design activities in a planned, controlled and orderly manner.
3 c.
Quality standards are specified in design documents and deviations and changes fron those quality standards are controlled.
3 e.
Designs are reviewed by FBF, Inc. Frosident Appendix 3-1 Design Control h)' Procurement Document Cent,rol h a.
Procedures are established that clearly delineate the sequence of actions to be accomplished in the preparation, revicu, approval and control of procurement documents.
Anpendix h-1 Vendor Evaluation
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Page 2 of It 2-Li
- 5) Instructions, Procedures and Dratrings '
$ a.
Activities affecting qtvtlity are prescribed and accomplished in accordance with documented instructions, procedures or drauings.
-$ e.
The QA manager reviews and concurs with inspection plans;-tests, calibration and special process procedures; drauings and specifications and changes thereto. The president of FBF, Inc. over-views the work of the QA manager to assure full compliance with Appendix E to 10 CFR 71.
Appendix 5-1 Instructions, Procedures, Drasdngs
- 6) Document Control 6 a.
The review, approval and issue of docunents (such as listed in section 6 L) and changes thereto, prior to release, are procedurally controlled to assure they are adequate and the quality requirements are stated.
Anpendix 6-1 Document Control
- 7) Control of Purchased Ihtorials, l' arts, Components 7 a.
Qualified personnel evaluate the supplier's capability to provide acceptable quality services and products.
Appendix 7-1 Suppliers Quality Evaluation
- 8) Identification and
-Control of Ihterials, Parts and Components 8 a.
Procedures are established to identify and control materials, parts and conponents, including partially fabricated assemblies.
8 d.
Identification of materials and parts important to the function of safety-related systems and components can be. traced to the appropriate documentation such as draidngs, specifications, purchase orders, manufacturing and inspection docunents, deviation reports and pirisical and chemical mill test reports.
Appendix 8-1 Identification and Control of thtorials, Parts and Components
- 9) Control of Special Processes 9 a.
Special processes such as uelding, heat treating, nondestructive testing and cleaning are procedurally controlled.
9 b.
Procedures, equipment and personnel connected uith special processes are qualified in accordance uith applicable codes, standards and specificationn.
9 c.
3pecial processes personnel are qualified in accord-with customer specifications eg.: Welders qualified to ASME Section IX pressure vessel code, etc.
Appendices: 9-1 Helding Procedures; 9-1A Heat Treating; 9-1B Nondestructive Testing: _ Magnetic Particle, Dye Penetrant, lhllogen Gas Test, Visual Inspection, and Stress Relieving.
e.v Paga 3_ of h 2-1A-
.10) Inspection 10 a.
An inspection program which verifies conformance of quality-affecting activities with requirements is established, documented and accomplished in accordance with uritten and controlled procedures..
10 b.
Inspection personnel are independent from the individuals -perfoming the activity being inspected.
Appendix 10 Quality Control Check-Off Shoots (Inspection).
-.11)
Test Control ~
11 a.
-A test program to demonstrato that the item or component uill perform satisfactorily in service is established, documented and accomplished in accordance with controlled procedures.
11 b.
!!odification, repairs and replacements are tested in-accordance uith specifications.
11 c.
Written test proceduros eg.:- ASME or ASTM codes are followed as prescribed in specifications. Equipment is calibrated and personnel qualified as required by code specifications.
Appendix 11-1 QC Check-Off Sheet (Testing)
- 12) Control of Mcacuring and Test Equipment 12 a.
Provisions, contained in procedures, describe the calibration technique and frequency, maintenance and_ control of measuring test equipment.
12 b.
Moacuring and test equipnent is identified and traceable to the calibration test data.
Appendix 12-1 Equipment Testing and Calibration:
Micrometers, etc.
- 13) Handling, Storage and Shipping 13 a.
Special handling, presentation, storage, cleaning, packaging, and shipping requirercents are established and accenplished by qualified individual (s) in accordance with predetermined work and insrection instructions.
Appendix 13-1 Control of cleaning, handling, storage, packing, shipping and preservation of materials.
lb) Inspection Test and' Operating Status lh a.
Identification of inspection, test, and operating status of packages and components is known by affected organizations.
1h b.
The status of non-conforming, inoperative, or malfunctioning packages or components is identified to provent inadvertent use.
Appendix 1h-1 Identification Tags, !!arkings and Labels for Control of Inspection Tests and Operating Status..
.- ~.
Paga h of h 2-1A
- 15). !!on-Conformint; thtorial, Parts or Co tponmts 1$ a.
The ~ identification, documentation, segregation, review, disposition and notification to effected personnel or organizations of non-conforming mterials, parts, components or services are procedurally controlled. The nanager of QA has responsibility and authority for the disposition and approval of non-confoming items. The President of FBF, Inc. overviews the actions of the QA manager to assure compliance with Appendix E to 10 CFR 71.
Appendix 15-l !!on-Conforning thterials
- 16) ~ Corrective Action-16 a.
Evaluation of conditions adverse to quality (such as non-confomance, failures, malfunctions, deficiencies, deviations and defective natorial and equipment) is conducted to detemine the need for corrective action in accordanco with established procedures.
Appendix 16-1 Corrective Action Reports
- 17) Quality Assurance Records 17 a.-
Sufficient records are naintained to provide documentary evidence of the quality and safety of items and the activitics affecting quality and safety.
17 b.
QA records include work papers, logs; results of reviews, inspections, tests, audits and natorial analysis; monitoring of work perfomance; qualification of personnel, procedures and couipment; and other documentation such as drawings, specs, procurement documents, calibration procedures and rerorts; non-conformance reports; and corrective action reports.
17 f.
Records storage facility is a concrete and steel vault located and secured to prevent loss or damago due to fire, theft or water.
Appendix 17-1 QA Records rotention, Duration, Location and Responsibility.
- 18) Audits ld a.
ludits are perfomed in accordanco with written procedures or check lists and conducted by trained personnel not having direct responsibility in the areas being audited.
18 b.
Audit results are documented and then reviewed with management having responsibility in the area audited.
18 c.
The President of FEF, Inc. takes the necessary action to correct the deficiencies revealed in the audit.
Appendix 18-1 Audits: Nork Areas, Activities, Items and Review of Documents and Records.
b 7-z, APPE DIX 2-1B Page 1 of 2
{FBF, Inc.
Safety Related Structures, Systems and Components Controlled by the-QA Program The follotring safety related structurcs, systems and components are controlled
- by the FBF,;Inc. QA_prcgram:
Uuclear Containers.
.2-R innor container vessel Tube or pipe -~ size: 'I.D.; I.H.; & thickness Threads.inside tube for closure-plug Threads outside tube for closure cap.
Proper scalant on. threads and cap or plug Cap or plug for R closure Label on side of 2-R c.g.; radioactive material Cleaning 2-R tube.
Nelding on plate -bottom-end closure Plato size 'and thickness for closure
'clelding procedure qualification Welder qualific stion Material analysis plate, tube or pipe and closure cap or plug.
Identification throughout process
-Documentation' check-off cheets and QA records Cortificatirn to specs
-Insertion and fit inside insulation Source holder fit inside 2-R (if applienble)
Lead shielding 'inside or outside 2-R or both Insulation around 2-R g.
Type insulation: fiberboard, plywood, other Certification - physical and chemical analysis of insulation (if applicable)
Sn:ing the insulation to size outer drun Reutering insulation to size of 2-R Fitting' insulation-into outer container Fitting insulation around 2-R Gluing and nailing - specs In-laying 2-R support - plywood
!!aintaining specs on wall - top and botton thickness of insulation Documentation - check-off sheet and QA records Certification to specs Fitting Icad shielding around inside insulation (if applicable)
Identification throughout process Outer Protective Drum Size drum, type, metal' thickness,no. rolling hoops Closure,1 cover, corrigations, notal thickness, convexity Closure ring - gauge metal drop forged lugs, one lug threaded j
Bolt - si::c, nut, seal hole size and location Vents in drum - size and location Vent covers - type, presence Markings - label - DOT specs - customer infornation on label
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- Paga 2 lcf 2 ;
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.. Paint r-l color - paint specs 9/
.' Documents'- check-off' sheet'QA: records.
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'Certificaticn - embossed in' drum-
! D(7f cpecification : certification' by:FBFji Inc..
.QA package corts -_ nill ~ analysis - check-off sheets
.-,e
-QA packago_ Estorage --in vaultj
> =
- Audit
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APPENDIX 2-10' FBF, Inc.
Resolution:of Disputes Involving Quality Between QA/QC' Personnel and Other Departments
- FBF,:Inc. foStors a policy of cooperation between departments and employees,
.which is especially offective and fruitful with cross-training on jobs anong the various functions in order to balance the work load. Such a policy and cooperative spirit:among employees provides a strong esprit' de corps'that enhances quality-and makes resolution of disputes involving quality betwe'en QA/QC personnel and other departments 1cas of a problem.-
llowever, when such disputes do arise, the President of FBF, Inc. fully supports the QA manager in demanding high quality work and simply settles any such dispute by--
cdict in favor of quality after reviewing the facts of the disagreement..This is c1 ways handled in a diplomatic yet' firm manner to assure on going cooperation and support of the QA program.
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APPENDIX' 4-1 FBF, INCORPORATED
' ' ~ '
Tare 1 of h
. VENDOR EVALUATION
'DATE BUYER 1.0- Vendor - General
.1 1.1 Vendor Name 1.2 Vendor Address-1.3 Vendor Teleohone Number i
1.4 Type of ownership 1.4.1 Privately'0vned 1.4.2 Publically owned
'1.4.3 Subsidiary 1.5 Usual Products or Services 2.0 Organization 2.1 Key Personnel (Name and Title) 2.1.1 Engineering 2.1.2 dunufacturing 2 '.1. 3 Sales 2.1.4 Contract Administration 2.1.5 Are Above Separate Functions?
2.1.6 Organizational Chart Availabic Yes/No Attached 2.2 Summary 3.0' Business Activity / Financial 3.1-Date Company Was Founded
Wrendi> 4-1' lure 2 cT h
~3.2 Net 1 Sales Per Year 3.2.1 Sales 5 years ago 3.3 Net Profits Per Year
% of Sales 3.3.1 -Profits 5 years ago
% of Sales 3.4 Vendors Present Capaelty 3.4.1 Percent of Canaelty Currently Utilized 3.4.2 Number of Shifts 3.4.3 Ability to Add Additional Shifts 3.4.4 Expansion Plans 4
3.4.4.1 For Manuf acturing 3.4.4.2 For offices 4
3.4.4.3 For Warehousing i
3.4.4.4 Other 3.5 Is Vendor involved With Government Contracts 3.5.1
% Cf Total Sales 3.6 Who Is Vendors Largest Customer 3.6.1
% of Total Sales 3.7 Average Shoo Charging Rates 3.8 1s Annual Report.Available Yes/No Attached 3.9 Is D & B Report Available Yes/No Attached 3.10 Summary 4.0 Labor Relations i
4.1 Number of Employees 4.1.1 office 4.1.2 Hourly 2
A ppendl y 4-1
. Tare 3 of 4 4.2--Are.Emotoyees Unioniz'ed 4.2.1 Office 4.2.2 Shoo
.4.2.3 Name of Union (s)
- 4. 3 - What is Status of Contract 4.3.1 Renewat'Date 4.4 ~What is Labor History 4.4.1 Number of Strikes During Last 10 Years 4
4.4.2 Duration of Strikes 4.4.3 What Were The Key Issues 4.5 Type of Work Force 4.5.1 Skilled Unskilled 4.6 What is Stability of Vork Force 4.6.1 If Large Turnover. Why #
4.7 What Is Worker Attitude 4.8 Summary 5.0 Faellities and Equipment 5.1 Site of Plant 5.1.1 office 5.1.2 Plant 5.1.3 Storage 5.2 Is Equipment List Available Yes/No Attached 5.2.1 - Approximate Average Age of Equipment 5.2.2.Is Equioment Sultable For Our Needs 5.2.3 Is Equipment Maintained Properly 5.2.4.Does Company Have a Preventative Maintenance Program 3
(.
A r[ en'!i y 4-1 5.'3 lWhat I's The General Plant _Aooenrance I a re la cf h 5.4 Is There A Definite Work Flow Pattern
.5.5 W111 Vendor Do All Operation In House
.5.5.1 If Not what Will Be' Subcontracted 5.6. Does Vendor Close Operations For Vacation 5.7 Anoroximate Lead Time For Product Under Consideration 5.8 Summary 6.0 Energy and Availability of Raw Materials 6.1 Type of Energy Used 6.1.1 Any Cut Backs or Interruptions 6.1.2 Are Cut Backs Anticipated 6.2.Back Up System 6.2.1 What % of Production Can Be Maintained With Ihis Back Uo System 6.3 Is Vendor Exeoerlencing Difficulties In obtaining Raw Materials 6.3.1 Does Vendor Have Alternate Supoller's 5
6.3.2 Observe Tyoes of Raw Materials and Equioment 6.3.2.1 Are They of Good Qualityt 6.4 Summary 7.0 Customer Vendor and Community Relations 7.1 Obtain List of Five. Largest Customers and Their Telephone Numbers l-4 I
FBF, INC.
Fage 1 of 5 SUPPLIER QUALITY EVALUATION TO BE COMPLETED BY BUYER NAME OF BUYER PRODUCTS OR SERVICES FOR WHICH SUPPLIER IS BEING CONSIDERED TYPE OF QUALITY EVALUATION INITIAL ()
REINSTATEMENT () RENEWAL (])
SIGNATURE OF BUYER GENERAL INFORMATION TO BE COMPLETED BY SUPPLIER AND RETURNED TO BUYER
- (COMPLETE THESE ITEMS ONLY IF THEY ARE APPLICABLE TO THE PRODUCT OR SERVICE YOU ARE TO PROVIDE TO FBF).
1.0 NAME OF COMPANY I.I NUMBER OF PLANTS OR FACILITIES 1.2 ADDRESS AND LOCATION OF PLANTS OR FACILITI5:S IN WHICH PRODUCTS FOR FBF WOULD BE MANUFACTURED OR SERVICES FOR FBF PERFORMED i
2.0 NUMBER OF EMPLOYEES ASSOCIATED WITH PRODUCTS OR SERVICES OF INTEREST TO FBF 2.I PRODUCTION 2.2 ENGINEERING 2.3 QA/QC 3.0 NAME AND POSITION.0F KEY PERSONNEL INVOLVED IN:
3.1 POLICY & OVERALL MANAGEMENT 3.2 ENGINEERING 3.3 MANUFACTURING 3.4 OUALITY ASSUR ANCE I
l
.41.} e nd i ) 7-1 Tare 2 Of 5 SUPPLIER QUALITY EVALUATION 4.0 PREVIOUS CONTRACTS:
4.I HAS YOUR COMPANY WORKED ON NUCLEAR COMPONENTS:
YESO no O TYPE OF WORK PERFORMED:
4.2 WHAT TYPE OF WORK, IF ANY HAS YOUR COMPANY DONE FOR FBF7 5.0 OUTSIDE SUkVEILLANCE WITHIN PLANT OR FACILITIES AS THEY RELATE 10 Q.C.:
5.I COVERNMENT INSPECTORS:
YES O no O tr so
"^"t ^or"cv 5.2 CUSTOMER INSPECTORS:
5.3 CUSTcMER INSPECTION PERMITTED:
YES O "o O 6.0 DOES YOUR COMFANY HAVE A WRITTEN OR DOCUMENTED QUALITY SYSTDt?
YES O NO O IF YES, INDICATE Tile QUALITY SYSTDI REQUIREMENTS TilAT SYSTEM IS INTENDED TO MEET:
(CHECK APPROPRIATE)
O"i'-9-9858^
QMIL.I-45208A Q 10 CFR 71 APPENDIX E QANSIN45.2 QOTHER:
SPECIFY:
7.0 INDICATE THE ESSENTI AL ELEMENTS CONTAINED AND CONTROLLED BY WRITTEN DOCUMENTS IN YOUR QUALITY' PROGRAM.
ITDIS LISTED CORRESPOND TO SECTIONS OF 10 CFR 71 APPENDIX E:
Q QUALITY ASSURANCE PROGRAM (QUALITY SURVEILLANCE OR QUALITY CONTROL)
QINDOCTRINATIONANDTRAINING O oxo^*iz^ tion 2
Appendix 7-1 face 3 of 5 SUPPLIER OUALITY EVALUATION O eacceatacar occusent contaot -
INSTRUCTIONS, PROCEDURES & DRAVINGS Ooocu"cutcontao' QCONTROLOFPURCHASEDMATERIAL, EQUIPMENT & SERVICES Q IDENTIFICATION AND CONTROL OF. MATERIAL, PARTS & COMPONENTS Ocostaot or secci^t eaoctsses Outwim O an^mc Oat ^ttat^tststisetconnorostuttout^tTarat" tut 0 "osotstauctive ex^xi"^tios Oet^tino 08tnorno no roanisc Ocuen1ua Oornea Oinsecction Ortst costaot
.Ocostaotor"t^suaiso&tcsttoureneur
.O n^sotixo. stoa ^ct, excx^cino. ^uo snierinc O issecction test ^"o orta^tino st^tus O na-wsroRaiso "Attarits, exats 4xo coseosturs O waatetive actim.
O o^ ^"o oc accoaos O ^uoits 7.1 IS A COPY OF YOUR COMPANY QUALITY MANUAL AVAILABtE PRIOR TO ANY AUoli YES Q NO O 3
Kp1'endi x 7-1 b re 4 o f' 5
1F SUBCONTRACTED, To wHOM7 8.1 PLEASE CHECK TYPES Of WELDING PROCESSES USED BY YOUR COMPANY.
O c^s wetorsc (rcw)
O e'^ssa ^ac ce^w)
O surstoco "sta' ^ac (s"^w)
O t'scraos'^c (tsw)
O susaracto ^ac (s^w)
O t'scraoc^s (tow)
O cas "stit ^ac (c"^w)
O t'ectaon ac^"
O c^s tuscston' ^ac (ot^w)
- 9.0 IS NOSDESTRUCTIVE EXAMINATION PERFORMED ON YOUR PRODUCTS OR INVOLVED IN YOUR SERVICES YESo N00 9.1 ARE NONDESTRUCTIVE EXAMINATIONS PERFORMED BY.YOUR COMPANY OR SUBCONTRACTED 7 EXPLAIN:
9.2 CHECK THE TYPE OF NONDESTRUCTIVE EXAMINATION METHODS USED BY YOUR COMPANY.
O arDiocateHY O EDDY CUaRENr Ou'ta^ sonic O r'ouaescent es" eta ^"r Oa^cNEticPARriCtt O dye eExttR^xt 9.3 ARE NONDESTRUCTIVE EXAMINATION PROCEDURES QUALIFIED 7 YES O nc O 9.6 ARE NDE PERSONNEL QUALIFIED TO ANY OF THE FOLLOWING:
O sst-tc-ia O navSHiPS 230 1300 1 O"it-sto-221 Ootuta 4
SUPPLIER OUALITY EVALUATION Agendly 7-1 1,re 5 of 5 9.5 CHECK THE CODES OR REGULATIONS TO WHICH NDE IS PERFORMED.
O n^vSHieS 250-isoo-i O Mit-StD-2 71 ORoT QASMESECTIONV O ^S'"
9.6 ARE HEAT TREATMENTS PERFORMED BY YOUit COMPANY OR S9BCONTRACTED7 EXPLAIN:
- 10.0 ARE ANY OF THE FOLLOWING HEAT TREATMENTS PERFORMED?
O ^NNEAuNo O soa"^'izino O son"^'izinc witH oUEncH cootiuc OtE"eERisc OPOSTwELo HEAT TREATMENT O STABLIZING STRESS RELIEVING QHA'RDENING 10.1 HOW ARE HEAT TREATMENTS NORMALLY PERFORMED 7 O c^S FURu^CE O t0 cat HEAT TaEATMENTS QELECTRICFURNACE 00THER QOIL FURNACE
- 11.0 PLEASE FURNISH A COPY OF YOUR QA FMNUAL IF AVAILABLS, THAT FMY BE OF ASSISTANCE IN EVALUATION OF THIS REPORT.
- 12.0 NAME AND TITLE OF SUPPLIER REPRESENTATIVE COMPLETING THIS SURVEY FORM.
DATE:
5
7-1-78 A Ph,NDIl 12-1 Fare 1 of 5 FBF INC ItirERNAL QA PROCEDURES Section Ta Testing and Calibrating for Accuracy - flicrometers Micrometers are used sporadically by FBF employees in determining thickness of metals, size openings, and various dimensions, and must be checked at least semi-annually (preferably quarterly) against the gage blocks by the FBF QA representative, and any minor repairs and adjustments made.
If the micrometer is in error more than the allowable maximum, then it must be returned to the manufacturer for calibrating against the standards approved by the U.S. Bureau of Standards.
12-1b Care and Adjustment of Micrometers - Things FBF Employees Should Remember The micrometer caliper and other instruments equipped with micrometer heads are vital to the control of accuracy of manufacture in the shop.
FBF employees are encouraged to present the micrometers as often as once a quarter to have them checked against gage blocks, and minor i
repairs and adjustments are made, i
This policy enables the QA inspection department to control the accuracy of those gages which are company (FBF) property.
It benefits the employee by keeping the tools in first-class condition and promotes quality work.
The maintenance of this condition and the preservation of accuracy
._of measurements made with a micrometer are possible only if the user observes the rules of good practice. IIence:
.1
.A}Tendix 12-t
.lafe 2 of 5 1.
A micrometer should never be stored with its measuring anvils closed, because flat surfaces wrung together for any length of time tend to corrode. To prevent this, it. is good practice to leave a small gap between the anvils.
2.
A micrometer should be oiled in only one place--the micrometer screw--
and only with light clock oil.
Using a heavy oil, which can in the course of time become gummy, makes the micrometer insensitive and may cover up an error in the screw.
If a micrometer is stored for any length of time, or where it is likely to rust, it should be covered with a light film of oil and wrapped in oiled paper.
3.
A micrometer caliper may be traversed several hundred' thousandths by grasping the frame and rolling the thimble along the hand or arm in several strokes. Grasping the thimble and twirling the frame to open or close a " mike" is frowned upon by good mechanics, probably because it causes excessive wear of the screw.
4.
A micrometer caliper should never be used as a snap gage. The develop-ment of many types of special-purpose gages has limited the old practice of trying to make one gage or a few general gages do all of the work. Using a micrometer as a snap gage is not practical, because it does not hold its dimension well enough even with the clamp ring, and there is a real danger of springing the mechanism in gaging a slightly oversize part.
5.
The accuracy of measurements made with a micrometer depends to some extent on the measuring pressure used. The " feel" necessary to produce the proper measuring pressure between the anvils is acq'uired 2
1
.. m.
Appendix 12-1 Fare 3 of 5 by practice and comparing measurements with precision gage blocks or some other accurate standard.
It is actually possible for an expert. skilled in the use of a micrometer to duplicate his readings within one half of a tenth of a thousandth of an inch, h'henever a machine operator or. Inspector has an opportunity, he should compare his " feel" with that of someone else to be sure that he is using the correct pressure.
-A gage block or accurate plug gage can be used to settle any differences.
6.
Before a micrometer is used it is customary to wipe it off and to pull a piece of paper between the anvils.
7.
The micrometer screw should run free with no play at any peint in its travel. This adjustment is made with the nut, which causes the threaded sleeve to tighten on the screw.
8.
A micrometer screw that binds or has loose points along its travel cannot be corrected with the adjustable nut.
It must be returned to the gage maker. This condition is caused by abuse or uneven wear and is one of the most common ailments of micrometers.
9.
The micrometer mechanism should be cicaned whenever it becomes gummy, contains an abrasive grit, or whenever it is to be adjusted.
10.
The inierometer screw should be checked with a precision gage block in at least four places other than zero to verify _ its accuracy. The procedure consists simply of measuring a selected group of blocks.
11.
In adjusting a micrometer to read correctly, the thimble is not set to_zero when the anvils _are in contact, but is set at some dimension so as to distribute the error.
For example, if a L
3
_,a.
/tppndix 12-1 Face h of 5~
micrometer screw'had an accumulating error of.0003 of an incii in the length.of its travel and it was set correctly at zero, it would be off.0003 at one inch, flowever, if the caliper were set correctly,
.in the middle of its travel, it would be.00015 under at zero and
.00015 over at one inch, which is a much better condition.
It-is customary to give consideration to the size of the work measured with the micrometer and to set. if possible, the base somewhere near the mean. From this explanation it is obvious that just because a micrometer does not return exactly to zero when the anvils are in contact does not mean that it is not adjusted properly.
12.
When the faces of the spindle and anvil become worn and they are no longer flat and parallel to each other, the error should not exceed.0002 on a micrometer which is graduated to control measure-ments to a limit of.001, and should not exceed.00005 on a micrometer which is' graduated to control measurements to a limit of.0001.
Measuring a ball at several points over the surface of the anvils will show up any error it, parallelism.
Parallelism can be tested by means of two different size balls.
If the anvils are in error more than the allowable maximum, the micrometer usually is returned to the. manufacturer for repair. The manufacturer has a standard that is checked by the U.S. Bureau of Standards for use in calibrating the micrometer.
Records of Gage Block Testing for A' curacy and Calibration Against
~
c 1c Approved II.S. Bureau of Standards Gage Standards - Micrometers 1
A detailed record is maintained in the form of a log of the test checks given the micrometers as well as when it becomes necessary to i
l.-
4
Appendix 12-1
~'
Farc '5 of" 5 v
return the microme'ter to the manufacturer. for calibration.
Such records are available for review at any time upon request. The micrometer identification, -date of inspection,.the QA representative's initials and -
a note if the micrometer is returned to the manufacturer for calibration, etc.,.is' contained in the record.
I 5-
1...
7_1_78 e
ArtrJ&Il 15 1 l'a,Te 1 of 2
.s-FBF-INTERNAL QA PROCEDURES-Section 15-Ta Non-Conforming or Rejecteo Materia'Is:
llow to liandle and' Rework -
'FBF maintains an affective and positive system for controlling non-conforming materials, including procedures for the identification, segregation, presentation and disposition of reworked or repaired supplies.- All non-conforming supplies are positively identified with an appropriate tag noted to prevent use, shipment and intermingling with. conforming supplies..Such non-conforming materials are segregated in holding areas inside clearly marked containers marked " Rejected Materials" separate from in process conforming materials. These materials retain this special identification tag throughout any special reworking or repairing and are not returned to the mainstream of conforming materials until checked, tested and released by the QA inspector following the renewing or corrective process and the QA inspector signs or initials and dates the tag indicating acceptance.
Non-conforming materials not repaired or renewed are mutilated and p12:ed in the scrap container. Mutilation renders the material useful only as scrap.
1y ~7b hhat is Non-Conforming or Reject Material and hhat flappens to It?
Proper ide itification at the earliest step in the process is a 1-necessary. requirement for setting aside any material that does not-fully meet the specifications - (cither the customer's prints or P.O., DOT specs,
\\
NRC. requirements or FBF quality specifications).
oe s
iqpendi y 15-1 o
Fare 2 of 2 Any employee can raise the question of quality on any material at any time and request the supervisor, plant superintendent or QA representative to check the material for meeting the quality standards.
The FBF QA inspector spot checks regularly all operations and takes random samples of material from each step in the process to determine if the production units meet all specifications. A formalized check-off sheet is used to document the QA inspection, with each item checker-marked as having passed the QA inspection or Rejected as non-conforming and tagged and removed to the-Reject Container maintained in the East building next to the office. Thit location was selected to draw atten-tion to the rejects and to assure c.ose control and surveillance during the re-working, repairing or unewing operations. The QA inspector signs or initials and dates the check-oft heet for the material and operation inspected and material accepted as conforming.
Rej ected materials are noted on the QA check-off sheets at time they are tagged
)
and removed to the Reject Container. At no time shall rejected material be re-worked or repaired along with conforming materials. Such operations must be performed separately under the close supervision of the super-visor or plant superintendent, and the material re-inspected by the QA inspector when completely re-worked, while retaining the Reject Tag.
Each employee must realize that quality production is the best job protection, and always strive for a high level of performance in meeting product specifications to produce a high quality product.
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