ML20150D169

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Advises That Rev 4 to Topical Rept Acceptable for Membership to Continue Using Case Register & Associated Audits
ML20150D169
Person / Time
Issue date: 07/01/1988
From: Weiss S
Office of Nuclear Reactor Regulation
To: Marsh R
COORDINATING AGENCY FOR SUPPLIER EVALUATION (CASE
Shared Package
ML20150D172 List:
References
NUDOCS 8807130342
Download: ML20150D169 (2)


Text

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'o UNITED STATES g

8 NUCLEAR REGULATORY COMMISSION o

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WASHINGTON, D. C. z'J666

& 1 13S6 Mr. R. N. Marsh, Chairman CASE Nuclear Section c/o Florida Power & Light Company P. O. Box 14000 Juno Beach, el 33408 Daar Mr. Marsh:

SUBJECT:

NRC ACCEPTANCE OF REVISED CASE TOPICAL REPORT Fe have completed our review of the proposed Revision 4 to the CASE Topical

-Report. Based on our evaluation of the changes described in proposed Revision 4, we find that the revised topical report continues to meet the criteria of Appendix B to 10 CFR Part 50.

It is acceptable for the membership to continue to use the CASE Register and its associated audits as a substitute for pre-4

- award audits.

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With proper implementation of the additional controls given in Revision 4, the CASE Nuclear system may also be used to substitute for post-award audits, in this regard, CASE Nuclear members should be aware of Regulatory Position 3.2.3 of Revision 3 of Regulatory Guide 1.28 which states:

If more than one purchaser buys from a single supplier, a purchaser may either perform or arrange for an audit of the supplier on behalf of itself and other purchasers to reduce the number of external audits of the supplier.

The scope of this audit should satisfy the needs of all of the purchasers, and the audit report should be distributed to all the purchasers for whom the audit was conducted.

Nevertheless, each of the purchasers relying on the results of an audit performed on behalf of several purchasers remains individually responsible for the adequacy of the audit.

Please include a copy of this letter in Revision 4 of the top (ical report and submit a signed original in accordance with 10 CFR 50.4(b)(7) ii).

Future change: to this topical report should be submitted in accordance with 10 CFR 50.55(f)(3).

Any questions on the above should be addressed to the NRC reviewer, Jack Spraul,on(301)492-1021.

Sincerely, r

Sey ur H. Weiss, Chief Quality Assurance Branch Division of Licensee Performance and Quality Evaluation Office of Nuclear Reactor Regulation y g $7t w3 +2 y L t-t

e c-CASE - TR4 TOPICAL REPORT QUALITY ASSURANCE PROG 2AN FOR NUCLEAR SECTI0n 0F COORDINATING AGENCY FOR SUPPLIER EVALUATION REVISION 4 NAY, 1988 o

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R'. N. (Pete) N&rsh

' Chairman - CASE Nuclear Section j

George F. Dakin CASE Data Center Exccutive Director Dept. 4030, Bldg. 2002 CASE Association Aerojet TechSystems Telephone:

(916) 355-2098 P.O. Box 13222 or-3866 Sacramento, California 95813 i & & 5lalll.3'l ' % W

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TABLE OF CONTENTS Page_

I.

Introduction 1

A.

General 1

B.

Use of thn CASE Register 2

C.

Use of Source Evaluation Resulta 2

D.

Technical Requirements and In-Process Inspection 3

E.

CASE Nuclear Section Topical Report

-4 II.

Criter'on I - Organiustion 6

A.

C#.SE Association 6

1.

Classes of Membership 6

a.

Sustaining Members 6

+

b.

Associate Members 7

c.

At Large Sustaining Hembers 8

2.

Executive Committee 8

3.

President 8

4.

Vice President 8

5.

Secretary 9

6.

Executive Director 9

7.

CASE Data Center 9

8.

CASE Register 10 9.

Financing 13 l

B.

CASE Nuclear Section 31

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1.

Operations Committee 11 2.

Chairperson 12 3.

Vice Chairperson 12 l

4.

Secretary 12.-

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P,a,ge

-5.

Standing Committees 13 I

a.

Standards and Procedures Committee 13

b. "Membership 'and Promotior.s' Committee -

13 c.

Audit and Compliance Committee 14 d.

Source Certification Committee 15 e.

Materiel Committee 15

!II. Criterion II Quality Assurance Program 17 A.

Organizations Participating in the Quality Assurance Program 17 B.

Procedural Requirements 'f or Performing Supplier Evaluations 17 C.

Use and Evaluation of Checklists 18 D.

The Source Evaluation Cycle 19 1.

Pre-Evaluation Conference 19 2.

Investigative Phase 19 l

3.

Post-Evaluation Conference 19 E.

Evaluation Results 20 F.

Supplier Approval 20 G.

Deletion of Existing Register Listings ~

20-H.

Training and Qualification of Auditors and Lead Auditors 21 1.

Elimination of Conflict of Interest 21 IV.

Criterion V - Instructions and Procedures 23 A.

General 23 B.

Procedure Preparation, Processing, and Review 23 i

V.

Criterion VI - Document Control 24 l'

A.

Topical Report Distribution and Control 24 a

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aP ge B.

Procedure Distribution and-Contro1~

24 C.

CASE Register Distribution

-24 VI.

Criterion XVII - QA Records 25 A.

General 25' B.

Record Protection and Storage 25:

l C.

Responsibility for Record Transmittal, Retention, and Maintenance -

25 1.

Transmittal 25 1

2.

Retention 26 3.

Maintenance 26 i

VII. Criterion XVIII - Audits 28 i

A.

General 28 B.

Internal Audits 28 C.

Unsatisfactory _ Corrective !. e. ion 28 D.

Re-Audits 29 1

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SECTION I INTRODUCTION A.

General This Topical Report describes the organization of the Coordinating Agency for Supplier Evaluation, better known as the CASE Association, and the organizaticn and quality-related activities of the CASE Nuclear Section.

The CASE Nuclear Section was formed in April 1974, by industry initiative, as an instrument for reducing or eliminatt.ng redundant source evaluation surveys of suppliers of nuclear safety-related material, equipment, and services.

By mutual agreement, the-Sustaining Members of the CASE Nuclear Section perform source evaluations (Note source evaluations are audits at a vendors' facility to determine qualification for procurement award and/or to verify quality program implementation) in accordance with standardized methods, using qualified auditors.

Evaluations of major product or services suppliers will be conducted by audit teams compriced I

of multiple auditors representing sustaining member utilities.

Such l

evaluations will be of a duration suitable for assessing the supplier's performance toward furnishing a product which conforms with procurement i

document requirements.

Technical expertise in conjunction with such i

evaluations will be supplied as appropriate. Results of successful source evaluations are submitted to the CASE Data Center by utility sustaining members, and a list it suppliers with acceptable quality assurance programs is published at a minimum three times yearly in the CASE j

Register. i i

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Sustaining Members have access to the source evaluation data gathered

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by other Sustaining Members.

Such data can be obtained f rom the CASE Data Center or directly from the Sustaining Member who performed the source evaluation.

Through such cooperative action, the total number of source evaluations performed within the nuclear industry will be reduced and significant benefits will result for both the purchaser and the supplier.

B.

Use of the CASE Register The CASE Register contains source information about suppliers of material, equipment, and services to the nuclear industry.

Controls described elsewhere in this Topical Report ensure that these data are creditable.

Some of the products listed in the CASE Register are commercial grade (catalog and off-the-shelf) items.

Either they do not require unique design or special engineering specifications; or they are manufactured to

ational standards or by processes genere'ly automated or highly repetitive; or there is little chance for e, tot during manufacture to effect their safety-related characteristics. Fo: such items, reference to the CASE Register shall provide adequate docum(ntary evidence of source evaluation; they can be purchased directly, without performing a supplier source evaluation.

C.

Use of Source Evaluation Results For items 'hich are not commercial grade or which require unique

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design or special engineering specifications, reference to the CASE Register alone shall not provide adequate evidence of source evaluation.

i Copies of survey results shall be obtained from the CASE Data Center or from the Sustaining Member who performed the survey. The purchaser shall tvaluate the survey results to determine it che information contained _

4 therein satisfies requiremente and ensures that the supplier's quality l

program is acceptable for the item being procured.

In such cases, the CASE survey results and its evaluation together provide documentary evidence that the purchaser performed an acceptable supplier evaluation.

Sustaining membe's are responsible for reviewing the' results of source evaluations, obtained from the CASE Data Centee or the CASE Member who performed the evaluation, to determine if such evaluation information is acceptable for and representative of the. item to be procured.

Also, Sustaining Members are renponsible for the results of such evaluations when used in support of their procurement activities and assuring that the I

supplier.is capable of meeting their specific purchase order requirements.

D.

Technical Requirements and In-Process Inspection CASE source evaluations are performed to determine if a supplier's quality assurance program is being ef f ectively implemented to meet the i

requirements of quality standards specified in a procurement document.

8 i

CASE source evaluations are intended to verify the performance o a 1

supplier's quality activities as pertinent to products and services.

Thus, CASE Members are responsible for conducting their own technical cxaminations and evaluetions to determine whether suppliers can meet l

requirements of particular contracts and specifications.

Similarly, a CASE source evaluation does not relieve the purchaser of his I

responsibility for providing any req' aired in process inspection to determine that a particular item is being manufactured or fabricated to specification or design requirerents or for determining the acceptability of the final product.

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E.

CASE Nuclear Section Topical Report The CASE Nuclear Section provides a cooperative system that assists purchasers of nuclear safety-related material, equipment, and services in meeting the cource evaluation requirement of 10CFR50, Appendix B,

Criterion VII, Control lof Purchased Material, Equipment and Services.

This Topical Report describc4 this cooperative system and the administrative and quality-related activities of the CASE Nuclear Section.

The administrative activities of. the CASE Nuclear Section are controlled by the CASE Association's Statement of Principles and Bylaws.

The quality-related activities of the -CASE Nuclear Section shall be subject to review and comment by the Nuclear Regulatory Commission and shall be controlled by the requirements identified by the word "shall" in this Topical Report.

The quality-related activities of the CASE Nuclear Section are described in this Topical Report in relation to the ~six Criteria of 10CYR50, Appendix B,

which apply to the evaluation of suppliers' quality assurance programs; that is, in relation to Criteria I, II, V, VI, XVII, and XVIII. The remaining criteria of 10CFR50, Appendix B,

do not apply to CASE Nuclear Section activities and are not addressed here.

This Topical Report gives details to support the following:

1.

The Organization and Quality Assurance Program of the CASE Nuclear Section fulfill the requirements of Criteria I and II;

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2.

The activities of the CASE Nuclear Section are prescribed by l

f documented procedures as required by Criterion V.

3.

Procedures which document the basic practices of the CASE Nuclear Section are prepared and distributed as required by Criterion VI. 4 l

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4.

Records which provide evidence of compliance with this Topical Report are prepared, transmitted, maintained, and-stored as. required by l

Criterion XVII.

5.

The activities of CASE Sustaining Members are periodically audited in accordance with the requirements of Criterion XVIII.

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SECTION II CRITERION I - ORGANIZATION i

A.

CASE Association t

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The Coordinating Agency for Supplier Evaluation (CASE Association) is an organization of professional quality assurance personnel-from volunteering industrial companies and utilities.

It is a nonprofit e

j Association dedicated to reducing the cost 'of procuring quality materials and services for the represented industries and.their customers.

The Association is organized by Sections which serve respective industry j

groups.

It is governed as a unit by a-duly-adopted Statement of i

Principles and Bylaws and is managed by an Executive Committee consisting

't of representatives feca each industry Section.

The CASE Association Organization Chart is attac,hed.

l 1.

Classes of Membership CASE has Sustaining Members and Associate Membe rs.

Other j

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classes, including the
rights, privileges, restrictions, and l

4 obligations of such classes, may be established by properly enacted 1

amendments to the Bylaws.

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a.

Sustaining Members i

Sustaining Members of CASE are firms determined by the

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Membership Committee to be professional'ly recognized as part of their respective industries. Each Sustaining Member is entitled to one vote on each matter submitted to a vote of the membership.

In the CASE Nuclear Section, Sustaining Members have agreed to (1) Provide and maintain a current list of approved supplier data in accordance with standards established in Coordinating

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Agency for Supplier Evaluation Nuclear Section Operating Plan.

A Sustaining Member may also qualify by serving as an active member of the Audit and Compliance Committee.

(2) Maintain a record of the quality attainments and performance histories of approved suppliers.

-(3) Maintain procedures and qualified personnel ; delegated internal responsibility for supplier evaluation and approval to meet minimum standards established by Coordinating Agency for Supplier Evaluation Nuclear Section Operating Plan.

(4) Conform to the requirements of this Topical Report and to the Statement of Principles and Bylaws and Nuclear Section Procedures of the CASE Association.

(5) Furnish data related to approved services to other Sustaining Members.

Sustaining Membership may be terminated when evidence has been obtained that the Member no longer meets the requirements listed in paragraphs (2),

(3),

(4),

and. (5) above.

Upon termination, all information previously submitted to the CASE Data Center by the te rminated Member shall be deleted from the CASE Register.

b.

Associate Meabers Associate Members of CASE are firms which the Membership Committee considers to be professionally recognized as part of their respective industries, which provide services and/or supplies to a member of the industry, or which are interested in supporting the Association.

Associate Members receive copies of the CASE Register bct they do not have voting privileges and are f

1 not entitled to receive supplier evaluation data from Sustaining Members related to approved sources of supply.

c.

At Large Sustaining' Members Does not apply to CASE Nuclear Section.

1 2.

Executive Committee The internal and external ' administrative affairs of cne CASE Association are managed by a.t Executive Committee which consists of no more than two members f rom each Operations Committee and each section or "Section At Large".

Each of the members of the Executive Committee represents also a corporate Sustaining Member of the Association and is employed by the corporatu Hember during his term of office. The i

Executive Committee's primary function is to administer the overall business affairs of the association, and does not give technical guidance to the individual sections.

l 3.

President The President of CASE is the principal executive officer of the Association.

The President manages all of the business and affaire of the Association, presides at all meetings of the Member, and of the I

l Executive Committet, signs all documents which the Executive Committee has authorized to be executed, and perf orms all duties incident to the i

l office of President and such other duties as may be prescribed by the Executive Committee from time to time.

4.

Vice President l

In the absence of the President of CA3E, or in the event of his inability to act, the Vice President performs the duties of the President.

The Vice President also performs such other duties as from 0

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time to time may be assigned by the Executive Committee or the President.

5.

Secretary The Secretary of CASE keeps the minutes of the meetings of i

Memb.rs and of the Executive' Committee, sees that all reports are duly filed and that all notices are duly given in accordance with the provisions of the Bylaws; is custodian of the Association records; and, in general, performs all duties incident to the office of Secretary and such other duties as f rom time to time may be assigned by the President or by the Executive Committee.

6.

Executive Director The Executive Director is appointed,by the Executive Committee and reports to the President.

The Executive Director is responsible for the execution of orders of the Executive Committee -and the management of such central office functions as the Executive Committee may establish. The Executive Director is an ex-officio member of the 1

Executive Committee but does not have voting privileges.

The Executive Director is eligible for compensation as established and approved by the Executive Committee.

I 7.

CASE Data Center The CASE Data Center is located at Aerojet TechSystems Company in Sacramento, California. It functions as a subcontractor to the CASE Association and provides an independent Review 3oard to review l

I supplier evaluattan data submitted by Sustaining Members of the Association.

The Review Board shall be composed of the Manager of the CASE j

i Data Center and at least one additional quality engineer. This Review -

.o Board shall review the submitted documentation before any supplier is listed or retained in the CASE Register.

This review shall be performed to verify that (a) an approved checklist was used' to conduct the~ source evaluation of the supplier.

(b) a qualified lead auditor led the evaluation.

(c) all sections of the checklist have been addressed and suf ficient objective evidence has been documented to allow proper interpretation and. auditing of the source evaluation-results and re-evaluations.

(d) appropriato requirements of this Topical Report have been set.

(e) any findings identified are minor in nature.

8.

CASE Register

-1 The CASE Register, published and distributed by the CASE. Data Center in Sacramento, California, is divided into Sections for each Operating Section. The Nuclear Section of the Register consists of an 2

index of suppliers who have been evaluated by Sustaining Members of the Nuclear Section and certified as having established-quality assurance programs conforming to the requirements of 10CFR50, Appendix B; ANSI N45.2-1977 (as supplemented or modified by the regulatory position of Revision 2 of Regulatory Guide 1.28, February 1979);

or other quality standards, as appropriate.

Sample pages from a recent edition of the CASE Register are attached for illustrative purposes.

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The Register shall identify the specific products or services for which particular quality assurance programs were evaluated; name and address of the company evaluated; date of evaluation; Sustaining i

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, Member who performed the evaluation; quality standard used as a basis for the evaluation; and other portinent information.

9.

Financing The CASE Association finances its operation th'ough membership r

fees and sales of the CASE Register, an index of suppliers to the nuclear industry. The only expenses of CASE are those related to the publication and distribution of the Register, to the operation of the CASE Data Center, and to the Executive Director.

B.

CASE Nuclear Section The CASE Nuclear Section is organized to facilitate the procurement of material, equi pment, and services from all suppliers (including fabricators, designers, architect / engineers, NSSS suppliers, and other vendors) to the Nuclear Power Industry by eliminating redundant evaluations of suppliers' quality assurance systems.'

Evaluations made by the Section include assessing each supplier's capability, and performance toward complying with applicable criteria of 10CFR50, Appendix B; ANSI N45.2-1977 (as supplemented or modified by the regulatory position of Revision 2 of Regulatory Guide 1.28); or other quality standards, as related to procured items and services.

1.

Operations Committn The Operations Committee, under the direction of the Chairperson, is the governing body responsible for providing technical direction to and conirolling the Nuclear Section activities. The CASE Nuclear Section is managed by an Operations Committee ' consisting of a Chairpercon and Vice Chairperson and a selected number of Committee members consisting of at least one member from each Standing Committee.

Individuals olected to the Operations Committee shall be,

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recognized quality professionals from Sustaining Members' quality assurance organizations. The Chairperson and Vice Chairperson of the Nuclear Section Operations Committee are representatives from utility CASE sustaining member companies.

2.

Chairperson The Chairperson is the principal executive officer of the CASE Nuclear Section Operations Committee. The Chairperson manages all the business of the Section, presides at all meetings of. the Members and of the Operations Committee, signs documents which the Operations Committee has authorized to be executed, and performs all duties incident to the office of Chairperson and such other duties as may be prescribed by the Operations Committee from time to time.

The Chairperson shall be responsible for ensuring that the CASE Nuclear Section complies with requirements set forth in the CASE Association Statement of Principles and Bylaws and this Topical Report.

The Chairperson is a member of the CASE Association's Executive Committee.

3.

Vice Chairperson In the absence of the Chairperson of the CASE Nuclear Section or in the event of the Chairperson's inability to act, the Vice Chairperson performs the duties of the Chairperson.

The Vice Chairperson also performs such other duties as f rom time to time may be assigned by the Operations Committee or its Chairperson.

4.

Secretary The Secretary of the CASE Nuclear Section, who shall be a l

i Sustaining Member, keeps the minutes of the meetings of the Section i

Members and of its Operations Committee; sees that all reports are duly filed and that all notices are duly given in accordance with the.

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provisions of the' CASE Statement of Principles and Bylaws; and performs all duties incident to the office of Secretary and wech other duties as from time to time may be assigned by the Operations Committee or its Chairperson.

5.

Standing Committees The CASE Nuclear Section maintains five Scanding Committees whose duties and responsibilities are as follows:

a.

Standards and Procedures Committee The Standards and Procedures Committee coordinates the development by Members of uniform standards, procedures, and techniques related to the purpose of the Association; establishes procedures governing the exchange of data among Section Members; provides procedures for clarifying, storing, evaluating, and disseminating data; provides and coordinates procedures for operating the Data Center effectively; and prepares and develops the recommendations and suggestions of the Members to further the purpose of the Association.

The Standards and Procedures Committee shall issue, control and maintain all procedures and changes thereto which document the operating practices of the CASE Nuclear Section.

The Standards and Proceduras Committee is responsible for the yoordination and final preparation of all additions, revisions, or deletions to the CASE Operating Plan and Topical Report.

b.

Membership and Promotions Committee The Membership and Promotions Committee of the CASE Nuclear Section is responsible for receiving and reviewing all applications for membership, classifying Members, and reviewing 1

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audit performance and auditor qualification procedures' for acceptability.

It also makes decisions on acceptance of Meshers, advising the Operations Committee of. these decisions, maintaining surveillance over the membership, and recommending termination of membership or changes in classification of Members.

The Committee directs the Standards and Procedures Committee to send controlled copies of the CASE Nuclear Section procedures to applicants accepted as Sustaining Members.

The Committee may also request, as appropriate, review by the Source Certification Committee of applicants' procedures for conducting source

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t evaluations and auditor qualifications.

4 The Membership and Promotions Committee promotes membership and active participation in the Association and coordinates and i

develops plans as directed by the Operations Committee or the membership to publicize the Association within the nuclear i

l industry.

The Committee is also responsible for compiling, maintaining, and distributing to the membership a roster of l

members names and addresses.

c.

Audit and Compliance Committee j

The Audit and Compliance Committee of the CASE Nuclear Section, chaired by an elected or chosen Sustaining Utility

Member, shall conduct annual audits of the CASE Data Center; annual audits of the Sustaining Members who are inputting information to the Data Center; and biennial audits of the CASE Nuclear Section; to ensure that the Data Center, Members, and Nuclear Section are complying with the CASE Statement of Principles, Bylaws, Operating Plan, and this Topical Report.
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1 El The-Audit and Compliance Committee shall have the, authority, i

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and organisational freedom to identify quality problema; -to 1.

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~ initiate, recommend, or provide solutions through designated

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' channels; and to verify implementation of solutions.-

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d.

Source Certification cosaittee e

The Source' Certification Committee of the - CASE Nuclear-

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A Section develops and coordinates preparation o'f evaluation I

standards' for approving and re-approving sources.of supply for 1

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sacerial, equipment, and services.

The Source Certification

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Committee shall establish specific baselines. to -ensure that t

regulatory requirements for ' nuclear quality assurance are me t.

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For this purpose the Source Certification Committee has

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- established standardised CASE.-supplier evaluation checklists in 1

accordance with the Nuclear Section Operating' Plan consistent with 4

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the requirements of Regulatory Guide 1.28. Revision 2.

Sustaining Members shall use a standardised CASE checklist or an equivalent checklist approved by the. Source Certification Committee.

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Checklists of other quality standards utilised by CASE shall also l

f be approved by the Source Ccrtification Committee.

e.

Materiel Consittee l'

The Materiel Committee of the CASE Nuclear Section has~

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primary responsibility for determining the format and content of the CASE Register. The Committee determines what types or classes of suppliers are listed, wha t information about suppliers is I

useful, and what arrangement of data permits the most rapid and accurate retrieval.

This Committee is also responsible for l

l establishing the ainlaus requirements for operating the CASE Data

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Center and providing instructions for the exchange, by Sustaining Members, of data on approved suppliers.

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,SECTION III CRITERION II - QUALITY ASSURANCE PROGRAM A.

Organisations Participating in the Quality Assurance Program a

The organisation and general operation of the CASE Nuclear Section are ~ described in Section IIB. The quality-related activitiesofthhCASE Nuclear Section shall be controlled by the requirements identified by the

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word "shall" in this Topical Report.

B.

Procedural Requirements for Performing Supplier Evaluations The CASE Nuclear Section shall develop and implement written procedures which comply with this Topical Report.. These procedures shall establish requirements for the activities of SustatningMembebsandshall be used in evaluating, documenting, and reporting data on supplier quality assurance programs for publication in the CASE Register.

Adherence to the requirements of these procedures shall ensure that the Nuclear Section's data on supplier evaluation is reliable and understandable so that these data can serve as objective evidence that suppliers have acceptable quality assurance programs for specified products or services.

Each Sustaining. Member shall determine the size, composition, responsibilities, and authority of evaluation teams based on the complexity of the ites being procured, and the nature of the supplier's quality assurance program.

Evaluation teams of only one individual are permitted as determined by the Sustaining Member after review of the preceding factors.

I Every evaluation team shall have a 1ead Auditor.

It shall be the responsibility of Sustaining Members to ensure that qualifications of auditors are controlled, maintained, and verified in.sceordance with their

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internal procedures. The composition of evaluation teams shall be such as to preclude any possibility of conflict of interest.

C.

Use and Evaluation of Checklists

-In evaluating suppliers, methods for comparing the compliance of quality assurance programs with nuclear quality assurance criteria are standardized by use of a CASE Supplier Evaluation Checklist, or one approved by the CASE Nuclear Section's Source Certif Jcation Committee.

P All applicable sections of such checklists shall be completed to indicate l

the manner by which quality assurance criteria established by 10CFR50, Appendix

5. ANSI N45.2-1977 (as supplemented or modified by the regulatory position of Revision 2 of Regulatory Guide 1.28), or other specified quality standards are satisfied.

CASE-approved checklists shall be used by the auditors of Sustaining Members who evaluate suppliers for listing in the CASE Register.

These checklists shall document the physical evidence examined during the facility evaluation so that other Sustaining Members can properly interpret the results.

Deficiencies identified shall be evaluated by the Sustaining Member to determine whether or not they are likely to affect the supplier's capability to provide the quality product for which he is being evaluated.

Minor deficiencies may exist, but they shall not be such as to preclude the placement of a procurement order by a Sustaining Member, or to preclude submittal of the supplier's name to the CASE Data Center for listing in the CASE Register.

However, when the results of such an i

evaluation are submitted to the CASE Daca Center, the minor deficiencies shall be identified.

Verification of corrective action for the minor i

deficiencies shall be obtained by the Sustaining Member and reported to

the CASE Data Center within six months of the source evaluation.

If acceptable corrective action is not verified by the end of the six-month

period, the Sustaining Member who submitted the source evaluation shall, within ten working days, request the CASE Data Center to remove the supplier's name from the CASE Register.

D.

The Source Esaluation Cycle Source Evaluations of suppliers' quality assucance programs shall be performed as follows:

1.

Pre-Evaluation Conference:

Auditors shall conduct a pre-evaluation conference with appropriate levels of supplier management to advise them of the evaluation scope and plan, introduce auditors, meet counterparts, discuss the evaluation sequence and establish communication channels that will be used during the evaluation.

2.

Investigative Phase Auditors shall select those records and/or equipment deemed necessary to verify proper implementation of the supplier's quality program.

Physical verification of objective evidence shall be required.

Verification of quality shall be accomplished through surveillance, checking, and review of work activities and documentation.

3.

Post-Evaluation Conference: Auditors shall conduct a post-evaluation conference with the supplier to present their findings (satisfactory or unsatisfactory) and to cla rif y any misunderstandings developed during the course of the evaluation.

During this conf erence, the supplier shall be informed of any nonconformances or discrepancies and shall be requested to provide and implement corrective action, or to provide rationale substantiating why such action is not necessary.

l Any corrective action taken shall be subject to re-evaluation action i

as deemed necessary by the auditing member.

E.

Evaluation Results Evaluation teams shall document results which approve a supplier's h

quality assurance program.

Copies of these results and checklists shall

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They are available to Sustaining Members who have met the requirements of paragraph (1) in Section 11. A. la.

o F.

Supplier Approval The initial supplier approval submitted to the CASE Data Center for inclusion in the CASE stegister shall be based on a documented on-site facility evaluation.

Annual evaluacions shall be based upon supplier performance or an on-site facility evaluation.

The Sustaining Member performing the annual evaluation based on supplier performance shall utilize personnel qualified in accordance with hist respective program, maintain all documented evidence for the annual <

evaluation and submit the annual evaluation results to the CASE Data Cen.t er.

t,!aleu s suppliers are successfully re-evaluated annually, they shall i

be deleted from the CASE Register.

Documented on-site facility evaluation will be retained in the CASE Register for a maximum period of two years.

G.

Deletion of Existing Register Listings i

l Upon identification by any Sustaining Member that the integrity of a Register listing becomes questionable because of a disaster (fire, flood, l

etc.),

unsatisfactory program implementation, notification by the Nuclear l

Regulatory Commission, discontinuance of product line or service, change i

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of address, loss of a capability, acquisition by another company, or other - -

such occurrence, the Sustaining Membe r which either discovers or is notified of the occurrence shall 1.

Notify the Sustaining Hember(s) responsible for the current supplier listing to re-evaluate and submit evaluation results to the. Data Center within three months.

4 2.

Notify the CASE Data Center to delete the listing of the supplier if..

evaluation results are not received within three months.

Section's Audit and Compliance Committee of. the 3.

Noti *y the Nucir above act.

e infotaation, investigation, and settlement of disputes between Sustatning Members if auch problems arise.

H.

Training and Qualitication of Auditors and Lead Auditors Within tiieir respective organizations, Sustaining Members of the CASE Nuclear Section shall ectablish requirements for.the qualification, training and certification of Auditors and Lead Auditors in compliance with ANSI N45.2.23-1978. Training to the requirements of the CASE Program i

will be provided by sustaining members to the'r respective auditors and lead auditors who perform source etaluations under che CASE Program.

Q (fication, training and certification records for auditor personnel shall be available and accessible to government regulatory agencies and, for internal audits, to the Audit and Compliance Committee.

I.

Elimination of Conflict of Interest i

Source Evaluations shall be planned, scheduled, and conducted tc preclude any possibility of conflict of interest.

Sustaining Member companies shall not submit supplier capability data to the CASE Data Center for each other. Also, a Division f.-

a Sustaining Member shall not submit data for another Division of the same parent organization. ' t-

\\

a Evaluations f ound by the Review Board to be in violation of these policies shall be voided as invalid... -....

s.

SECTION IV CRITERION V - INSTRUCTIONS AND PROCEDURES A.

General All quality-related activities of the CASE Nuclear-Section shall be

. performed in accordance with approved procedures. The Section's Standards and Procedures Committee shall be responsible for the coordination of the preparation, review, comment resolution, and/or ' approval, issuance and control of all CASE Nuclear Section procedures.

B.

Procedure Preparation Processing, and Review CASE Nuclear Section procedures are developed by'either the Standards and Procedures Committee or the Standing Committee responsible for the quality-related activity in accordance with CASE procedure.

The utandards and Procedures Committee performs a review to ensure the procedure is in accordance with CASE format, in conformance to regulatory requirements, in accordance with the CASE Topical Report, and in conformance with applicable criteria of 10CFR50, Appendix B.

Procedures aru reviewed by the Standing Committee responsible for the i

quality-related activity.

Procedures are presented to the Operations Conmittee for acceptance

and, upon concurrener are approved by the Chairperson, Operations Committee.

visions to procedures are processed in the same manner as the init tre.

s,.

s.

i H

SECTION V CRITERION VI - DOCUMENT CONTROL A.

Topical Report Distribution and Control Controlled copies of this Topical Report shall be issued to i

Sustaining Members of the CASE Nuclear Section.

Changes to this Topical Report shall receive Nuclear Regulatory Commission acceptance before implementation of the change.

B.

Procedure Distribution and Control Controlled copies of the CASE Nuclear _Section's procedures are issued to Sustaining Members as the CASE Nuclaar Section's Operating Plan.

The Operating Plan is kept up to date by the issue of new or revised

parts, sections, procedures, and appendicas as appropriate.

Holders of the Operating Plan are responsible for incorportting issued changes into their copies of the Plan.

Changes to the Operating Plan or any part of it are approved by a quorum (66%) of the Operations Committee of the CASE Nuclear Section before issue.

C.

CASE Register Distribution The CASE Re:ister, dated to indicate the latest revision, is distributed by the CASE Data Center to all Sustaining and Associate Members of the CASE Nuclear Section. The CASE Register is available to non-members on a subscription basis..

, o'

~

SECTION VI CRITERION XVII - QA RECORDS A.

General Identifiable and~ retrievable records shall be maintained to provide objective evidence of compliance with the. quality-related requirements of this Topical Report. These records shall include the following:

1.

Topical Report 2.

Nuclear Section Operating Plan 3.

Membership Applications and Status 4.

Auditor Qualification Records 5.

Supplier Source Evaluation Results and Checklists 6.

Supplier Re-Evaluation Documentation 7.

Internal Audit Reports 8.

QA Records Index B.

Record Pt..etion and Storage All quality-related records shall be signed and dated by authorized personnel.

To prevent loss or theft, deterioration by extreme environmental conditions, and destruction by fire or flooding, two sets of records shall be maintained, indexed, and kept in file cabinets in enclosed buildings at remote storage locations.

C.

Responsibility for Record Transmittal, Retention, and Maintenance 1.

Transmittal a.

Committee Chairperson--Upon expiration of his term-of of fice, each Committee Chairperson shall transmit all quality-related cocmittee records to the incoming Chairperson.

{.

b.

CASE Data Center--The CAliE Data Center shall transmit copies of

^

Supplier Survey Results, Checklists, and Supplier Re-Evaluation Forms to qualifying Nuclear Section Sustaining Members upon request.

c.

Secretary, Operations Cotmittee--The Secretary shall transmit a copy of the minutes of CASE Nuclear Section meetings to each Sustalaing Member of the Section.

2.

Retention All quality-related records shall be retained in the CASE record system for $hree years.

This does not relieve Nuclear Section Sustaining Members of the responsibility to retain records in accordance with regulatoty requirements.

3.

Maintenance The following organizations and/cr individuals shall maintain the indicated records:

Record Master Copy Duplicate Copy Topical Report Chairperson, Standards Chairperson, Operations and Procedures Committeu Committee Nuclear Section Chairperson, Standards Chairperson, Operations Operating Plan and Procedures Committee Committee Membership Applications Chairperson, Membership Sustaining Member 2

and Status and fromotions Committee Auditor Qualification Surveying Sustaining Surveying Sustaining Records Member Member i

Supplier Survey Results Surveying Sustaining CASE Data Center and Checklists Member Supplier Re-Evaluation Surveying Sustaining

. Surveying Sustaining Documentation Member Member j

Internal Audit Reports Chairperson, Audit and Chairperson, Operations Compliance Committee Committee - _ -.

Record Master Copy Duplicate Copy QA Record Index Chairperson, Standards Cheirperson, Operations.

and Procedures Committee-Committee s

4

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SECTION VII CRITERION XVIII - AUDITS W

A.

General The CASE Association's Nuclear Section's Operations Committee 'shall ensure that the Nuclear Section's Audit and Compliance Committe e's internal audit program covers Operation's. Committee activities, Standing Committee activities, CASE Data Center operations, and supplier activities of each Sustaining Hember who submits data to the CASE Data Center.

J B.

Internal Audits

~,

Members of the Audit and Compliance Committee shall meet the qualification and certification requirements for Auditor and Lead Auditor as required of Sustaining Members who perform supplier evaluations as necessary.-

Audits performed by Committee members shall.be performed in accordance with written procedures or checklists, results shall be documented and reviewed with the management of the audited Sustaining Member's organization, and an Audit Report shall be prepared _ and sent to the adited Sustaining Member for corrective action, if applicable.

The i

audited Sustaining Member shall reply to the audit within thirty days from receipt of the Audit Report with disposition and corrective _ action for each nonconformance.

C.

Unsatisfactory Corrective Action If the corrective action taken is considered unsatisfactory by the Lead Auditor, the audited organization's management shall be notified of this fact and requested to submit a revised response within thirty working days.

If the second response is unsatisf actory or not received within the _J

  • .<*e

'l specified time, thh matter shall be referred to the Chairperson, Audit-and Compliance Committee.

Suspension steps'shall be initiated either by the Lead Auditor or the Chairperson, Audit and Compliance Committee, and may result in deletion of the Member's data from the CASE Register, rejection of Member's data in.

the future, and/or notification' to other Sustaining Nembers, depending on the nature of the finding and the unsatisfactory response. The suspension action shall be determined by the Chairperson, Audit and Compliance

, Committee, with nctification to the Chairperson,. Operations Committee.

The Chairperson, Operations Committee, shall recommend - that 'the membership of the non-responsive Sustatning Fember be either changed or:

terminated at the next scheduled meeting or at a special meeting of the Operations Committee as nea.essary.

D.

Re-Audits Verification of corrective action shall be accomplished by re-audit, which may be performed by on-site verification of objective evidence or review of submitted data.

B -.

= _ - -. - -, _ - -

.. *

  • s.

Sam, e Page from l

l April 1987 Edition Misc CASE Pegister CASE Coordinating Agency for Supplier Evaluation REGISTER Register of Quality Control Evaluated Suppliers 1

1 The CASE Register is published as a service to the Aerospace and Nuclear industry. The goal is to assist in the i

economic procurement of quality supplies and services. Information contained in the following pages has been devt, loped by the publisher and other Aerospace and Nuclear companies. This is intended only as a central source of infor mation. We are unable, under the circumstances, to guarantee, endorse, or warrant the fitness of any supplier for a purpose intended by the user of this register.

This register will be revised and republished totally or in part at regular intervalt to keep the listing as current as practicable. Revisions to the listing will contain new suppliers or data as information is supplied concerning their j

aqherence to spe' %d quality requirements.

The su.) pliers listed have been evaluated by one or more sustaining members of The CASE Association.

"This Register does not purport to list all companies qualified and the nontisting of any supplier does not necessarily mean that any such supplier is not qualified."

Published By AEROJET

@ Tech % stems COMPANY - - - - _

..o s.

Sample Pags from g

April 1967 Edition Misc of CASE Register How To Use The CASE Register For Nuclear Listings i

Column headings are isted below with descriptions / comments regarding their meaning and use.

Supplier Supplier's name. address, and zip code.

CASE Member Submitting members identification number.

Evaluation Cateoory A = All criteria of OA System are covered and are satisfactory.

B = Some criteria of OA System not applicable to suppliers product - all criteria covered are satisfactory.

Status P = Partially complete survey - minor areas of corrective action are required.

Blank = All areas of survey are complete.

Product Desianation See Group Designations on page 6.

Quality System Code The code reflects the highest classification reported for the suppliefs basic quality system. The index for these codes is shown on page 6.

On-Site Date of submitting members on site survey.

Performance Update '

Date of submitting members last performance update.

Products / Processes An alpha-numerical capability code assigned to describe those capabilities for which approval is indicated in survey..

e.-

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l Sample Paga from April 1987 Edition Misc of CASE Register Quality System Approval Codes Group Desionatior$_.

1.

Complex - (Generally not inspectable for all characteristics upon receipt without expensive disassembly or destructive testing) 2.

Simple - (Generally completely inspectable uoon receipt)

System Codes Aerospace & Marine Systems Nuclear / Fossil O< O 2 2 h mI

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X Air Carrier R = CASE Standa.-d R-1 "L

X P

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X T

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  • = Supplier

" = Manufacture Please report errors / corrections /etc. to:

G.F. Oakin, CASE Data Center (916) 355 2098 Dept. 9430, Bldg. 2002 Aerojet TechSystems Company P.O. Box 13222 Sacramento, CA 95813 _ - -. _ _.

Y Sample Pa9e from.-

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Sample Paga from August 1988 Edition Misc of CASE Register ALPHABETICAL LIST OF SYSTEMS /SFECIAL PROCESS SlFPLIERS - Ni LEAR PAGE 1-CASE EVAL

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1 E 11/87 923-Y B

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2 C 03/% 03/88 917-J B

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j l

NUCLEAR SECTION ORGANIZATION CASE ASSOCIATION NUCLEAR SECTION EXECUTIVE COMMITTEE OPERATIONS COMMITTEE

~ ~ ~~~

Administrative Committee

- Chairman made up of two members from each section

- Co-Chairman

- Ten other members including five standing committee chairman STANDING COMMITTEES 1

AUDIT &

STANDARDS &

PROMOTIONS &

SOURCE COMPLIANCE PROCEDURES MEMBERSHIP CERTIFICATION MATERIEL l

_. -, _ _ _, ~... ~. _.. _ _.. _ _ _ _ _ _ _, _