Text

QA Program,Revision 5
	ML19242D040
Person / Time
Site:	07100024
Issue date:	07/09/1979
From:	; HITTMAN NUCLEAR & DEVELOPMENT CORP. (SUBS. OF HITTMAN
To:	;
Shared Package
ML19242D038	List: ML19242D037; ML19242D040;
References
	NUDOCS 7908140406
	Download: ML19242D040 (57)
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HIT T M AN NUC' TAR DEVELOPMENT CORPOR align C OL UMlt A PaapYLAND 2l04:

P O LICIE S AND P R O C E D U R E S A _ ~Y ASS R AXCE V A\\

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POL lCIES AND PROCEDURES HITTMAN NUCLEAR & DEVELOPMENT CC:dORATION QUALITY ASSURANCE POLICY It is the policy of Hittman Nuclear & Development Corpora-tion (HNDC) to supply products that satisfy the quality re-quirements of its customers and comply with all reculatory criteria within the scope of its business ventures.

The HNDC Quality Assurance ?ianual is the approved medium designating the guidelines to accocplish the obj ective of this policy.

The management fully endorses and requires compliance with the obj ectives of the HNDC Quality Assurance !!anual.

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s POLICIES AND PROCEDURES CONTENlS IMES SECTION 1 QUALITY ASSURANCE PROGRAM 3

SECTION 2 ORGANIZATION.

9 SECTION 3 DESIG, CO:. TROL.

18 SECTION 4 FROCUREME.NT DOCUMENT CONTRot ol SECTION 5 CONTROL OF PURCHASED 'iATERIAL EQUIPMENT AND SER; ICES.

23 SECTION 6 IDENTIFICATI0:s AND CONTROL OF MATERIAL, PARTS AND COMPONENTS.

26 SECTION 7 HANDLING. STORAGE, AND SHIPPING.

28 SECTION 8 NONCONEORMANCE MATERIALS, PARTS OF COMPONENTS-30 SECTION 9 COERECTIVE ACTION.

33 SECTION 10 INSPECTION 35 I-SECTION 11 TEST CONTROL.

38 SECTION 12 1NSPECT.ON, TEST, AND OPERATING STATUS.

40 SECTION 13 CONTROL U MEASURING AND TEST EQUIPMENT.

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SECTION 14 CONTROL OF SPECIAL PROCESSES.

43 SECTION 15 IN STRUCTIC:'S, PROCEDURES AND DRININGS.

44 SECTION 16 DOCUMENT CO::TROI 46 SECTION 17 DU/sLITY ASSURANCE RECORDS...

48 SECTION 18 AUDITS.

50 ADDENDUM A (HSDC-Q-001A) APPLICALLE ONLY TO PROJECT Nff23.

DISTRIBUTION CONTROLLED ADDENDUM B (HNDC-Q-00.B) APPLICABLE TO TRANSPORTATION CASKS LICENSED UNDER 10CFR P/1RT 71 -

DISTRIBUTIO:s CONTROLLED ADDENDUM C (HNDC-0-001C) APPLICABLE 0:LY TO CECO PROJECTS.

DISTRIBUTION CONTROLLED Q_ua li t y Assurance lianua' HNDC-O-001 5

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POLICIES AND PROCEDURES SECTIDN 1 QUALITY ASSUEMCE PROGF21 1.1

_ General The HNDC Quality Assurance Pregram assures that the provisions of applicable Codes, customers speci fications,

Federal Regulations, and HNDC directices are fully implemented.

The Director of Eadwaste Disposal and Support Seriices is responsible for its establishment.

implementation, and execution.

The vehicle for trans-mittal of this program to all levels of management is the HNDC Quality Assurance Manual.

l 1.2 Applicability The HNDC Quality Assurance Program provides for direct participation in the safety and quality aspects of engineering, design, procurement, construction, inspec-tion and testing of HNDC supplied equipment. systems, and services, as required by Feceral Regulation, Customer Requirement, or HNDC Management Directive.

The HNDC QA Manager is responsible for ensuring that the described QA Program is fully implemer:ed by the HNDC organization, its vendors and subcontractors.

1.3 QA Program:

The program provides writter policies, procedures, and where necessary, in s t r. c tior.s covering the following quality aspects.

1.

Organization 2.

Personnel Training 3.

Design Control 4.

Frocurement Control 5.

Receiving Control 6.

Material Storage, Handling, and Maintenance 7.

Control of Special Processes 8.

Inspection, Test, and Assembly Status 9.

Nonconforming Material Control 10.

Corrective Action ll, Packaging Ex Shipping 12.

Document Control 13.

Control of Measuring and Test Equipment 14 Audits s

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POLICIES AND PROCEDURES The HNDC QA Manual (HNDC-Q-001) will be the controlling procedure for all applicable contracts and will set forth the minimum criteria applicable to delive ring a quality product.

Vendors and subcont rac tors may be delegated specific responsibi.';ty for qual:ty assurance by HNDC as an extension of the HNDC QA Program-Dele-gated program responsibility shall conform to this standard and be approved by HNDC.

1.4 Ouality Assurance Manual:

This manual and referenced appendices set forth the policy which address the requirements of 10CFE Part 71 Appendix E.

It also addresses the criteria gi en in 1XPE Cart 50

".ppendix E. Na5.2 and the NEC position paper 11-1 & 11-3.

Hwever, since these documents are designed to establish quality assurance criteria primarily for the safety-related portions of Nuclear Power Plants, their requirements extend beyond the needs applicable to the equipment and services supplied by HNDC Therefore, the HNDC QA policy and program implementation is based on an extraction from these documents and is designed to comply with their intent.

1.5 Quality Assurance Procedures:

Based on the policies in the HNDC QA Manual, detailed QA procedures are developed to implement and cont rol the program.

HNDC will conduct audits of i ts engineering, design, and procurement functions to ensure compliance with the HNDC QA program as outlined herein.

The GA Manager is responsible for conducting these audits and where corrective action is required, he will ensure compliance with the findings of these audits.

Vendors and subconmractors will be evaluated by HNDC to ensure that their Q.A Programs comply wit.h the require-ments of HNDC directives to the extent required on HNDC's contract spec i fica t i ons.

Vendors and subcon-tractors not mee t ins; t hese requirements may elect to conform to the H<DC program as applicable to the items being furnished to HNDC.

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POLICIES AND PROCEDURES 1.o Periodic Review of The Quality Assurance Program:

The prcparation and continued mair.tenance of the Quality issurance Manual is the responsibility of t he Quality Acsurance Manager.

all manuals w:11 he centrm 1 led unless specifically designated by t h e_

QA Manager.

The statoc and acequacy of the program a r. d its. manuals will be regularly reviewed by the Quality Assurance Manager This is supplemented by periodic audits conducted to assure implementation of the program requ i rer.en t s. and to revise the program to properly reflect changin; codes. standards, regulatory and operational require-ments.

1,7 Oualification Rep rments For O? %

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QA Mar.ager-A.

Education B.S.

Engineering or B.S.

Ma na :;emen t B.

Specialized, Technical Enowledge or Skills:

Technical knowledge should be supplemented with some basic knowledge of business practices.

The individual with a business background or degree should have a strong engineering background.

It is desirable that the individual have a working knowledge of industrial techniques such as welding, painting, t es ting and measurement practices and be familiar with applicable codes, standards, and federal regulations.

C.

Eind and Length of Experience:

Shall have a four year accredited Engineering or Science degree or equivalent from work experience with a minimum of four years quality-related experience, two years of which is related to electric power generation facilities.

Two vears of which is related to a position in a supe rv i so ry capacity is also desirable.

QA Engineer:

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Education:

A B.S.

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Specialized, Technical Knowledgc or Skills:

An individual with a B.S.

in Engineeri ng ; in addition, experience in fields of Quali t y Control /

Quality Assurance methods and basic k n ow l edy-for Quality issurance requirement' in nuclear industry is desirable.

C.

Kind and Length of Experience:

Shall have a four year accredited Engineering degree or equivalent work experience, and two years Quality related experience.

f.S Perst ine! Training TEAINING FLAN F0E OPEE.\\fIONAL QUALITY ASSURANCE PERSONNEL PURPOSE:

To establish the minimum training and experience requirements to effectively carry out the HNDC Quality Assurance activities.

It shall be the intent of this plan to ultimately qualify each individual to a level whereby his i-performance will insure the policies of HNDC will be en-forced.

APPLICABILITY This training plan shall apply to all persons assigned to the Quality Assurance Department, on a non-temporary basis.

This plan assumes the new employee, al-though possessing varied results in the nuclear power field and/or quality assurance field, is not conversant in the application of HNDC systems used in nuclear power genera-

tion, Based on the previous knowledge and work experience o f the new employee, the manager of Quality Assurance may delete selected portions of this plan to suit the indivi-

dual, Personnel employed prior to the implementation of this training plan shall, to the extent possible, satisfy its minimum requirements.

RESPONSIBILITY The Manager of Quality Assurance shall be responsible for implementing this plan.

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POLICIES AND PROCEDURES FROCEDURE:

The Quality s.ssurance training program is divided into four distinct sections.

Their order may be altered to suit the circumstances.

1.

Company Indoctrination - in which the employee is b ri e f"1 by his i:r.med i a t e supervisor on company policies using the guidance of "indiv: dual Orientation t'roced-ure," a cepv of which is placed in the emplosee's training record, idditionally, administrat:ce matters such as time sheet preparation, expense report pre-paraticn and Xerex machine operation are covered.

2.

Quality Assurance Introduction - in which tbt emplevee is ir t roduced to the overall purpose and philosophv cf t h e cm l i ty assurance ef: ort, and his i t.d i' i au a l job functicn.

This is a c c o.i.p l i s h e d b.s readia; references in section four, consultire the knowledcea;1e indi-vidual as to the applicativ.. of HNDC systems and com-plet.ing a progress interview (s).

The results of this interview shall be documented in the employee's train-ing record.

3.

Nuclear Theory (Applicable only to those new employees without prior nuclear experience) - in which the new I

employee gains a basic knowledge of nuclear plant design and theory The (xtent of this training will be determined on a case basis by the Manager of Ouality Assurance.

2.2 Orcanization

The HNDC Quality Assurance, Support Services, and Engi-neering Departments contribute to the OA Program as shown on the Organizational Chart, Figures 1.1, 1.2, and 1.3.

The responsibilities for the positions des-cribed on the charts are found in Paragraph 2.6.

2.3 Functional Assignments and Responsibilities The provisions contained herein describe ti,e authority, organizational freedom and independence of personnel performing Quality Assurance functions to identife quality problems, to initiatc, recommend or provide solutions and to verify implementation of solutions.

2.3.1 Director of Radwaste Disposal and Support Services The direct responsibility for the conduct and implementation of the Quality Assurance Program is assigned to the Director of Rad-waste Disposal and Support.

In this capacity, he has direct access to the General Manager and will exercise the manage-ment controls necessary to ensure that HNDL products meet the criterion of customer specifications, HNDC directives and applicable codes and regulations.

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'} h e specific responsibility to coordinate anc i'rg l e m e n t the Quality Assurance program is as-gr.ed to the Ouality Assurance Manager.

He raports to ths D: rector of Radwaste Dis-l poca arid Suppc r' c e rv i c e s and supercises the Qual"ty issuranc-

rgani;ition.

He also has direct access to ht General Manager to resolve problems hereby the Director of Eacwaste Disposal and Support Se rv i c e s and the Qual.ty i.ssu ance Manager arn not in a g r vr.e n

This gives him a degree o f f reedo:r requ::ed to ir.sure cualliv reined decisions are net corcrol2-d by acministrative a'.the 2ty Under t.ls direction cuality matters wili be segregated between the client, HNDC and its vendors and subcontractors for correction in a responsible and timely manner.

Responsibilities assigned to the Quality Assurance Manager within this Manual or its referenced Adden.um, may be delegated by him to other personnel provided that the indivi-dual has been p: oorly trained and is not responsible for ne work being performed.

2.4 Authority and Responsibili y The Quality Assurance Depa rt men t 's authority comes bv way of the clients imposed criteria, Federal Hegulations and HNDC's commitment to a Quality Assurance Program which wi11 enhance the qua1ity of our product, Persons performing quality assurance functions shall have sufficient authority and organizational freedom to:

(1)

Identify quality problems (2)

Initiate, recommend, or provide solutions, through designated channels (3)

Verify implementation of solutions (4)

Control further processing, deliverv or instal-lation of a nonconforriing item, deficiency, or unsatisfactory condition until proper disposition-ing has occurred.

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POLICIES AND PROCEDURES 2.5 Quali fi ca t ion of Personnel The Guality Assurance personnel shall possess the necessary skills and experience to pcrform the inspec-tion, test or audits on which they are assigned, n!1 Quality Assurance personne. shall be certified in accordance with the training program in Section 1 of this manual Documentation supporting this trrining will be developec and maintained.

2.6 Pos: tion Rest.onsibilities (see Figures 1.1.

l.2, and 1.3)

General "v,ager Responsibilit2es include thc deselupment an d in:ple-ment a tion c f ccrpcratt policy, including thc estab-l i s hme r. t and initiation of the HNDC Quality Assurance Program Director of Radwaste Disposal and Support Services Responsibilities include the establishment and im-piementation of functions within the sections reporting to him.

These include establishment, i m p l eme ri t a t i on,

and approval of the HNDC Quality Assurance Program.

Direct or of Marketing and Projects Responsibilities include the presentation of HNDC production and service applica ions to utilities and architeetural/ engineering iirms' proposal preparation; and input into the development of new products and services.

Also included is the establishment and in.plemen ta t ion o f func t i ons within the engineering and fiele projects groups.

Vice-President - Engineering Responsibilities include the establishment and imple-mentation of functions t ' thin the engineering group and the oversight of interna 1 research and development.

Material Control Supervisor Responsbilities include purchasing, e >, p e d i t ing, internal material control, and the decelopment and implementation of mat erial control procedures and instructions.

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POLICIES AND PROCEDURES Expeditor Responsibilities include expediting, oversight of 'he material store room, and the receipt and disposition of stored matcrial.

Contract AduinistratDr As the adn.in i s t ra t is e liaison with utilities and archi-t e c t u ra l /en e i nee r i n;, firms. his responsibilities includ.. the d i s t r i bu t i on o f ;,u rcha se orders, rcfcrenc<d specifications, and bid requests to appropriate ptrsonnel for t h c i r r e,1 ew.

Health Physics Officer Fesponsibilities include developing and implementing Health Fhysics procedures, monitoring radiation ex-posures of personnel, and oversight of the handling of radioactive material, Quality Assurance Manager Responsibilities include the development and implemen-tation of the HNDC Quality Assurance Program; verifica-tion of program implementation by audit' vendor evalua-tions; specification, procedure and purchase order review' i.a t e ri a l inspections; the development and control of Quality Assurance procedures, speci fi ca-tions, and instructions; and all ot her Qua li t y Assurance functions, unless otherwise specified in this manual.

Regional Operations Manager. Midwest Responsibilities include the coordination and scheduling of transportation cask shipments from the United States Midwest region.

Regional Operations Manager, Eastern Responsibilities include the coordination and scheduling of transportation cask shipments from the United States Eastern region; scheduling of cask maintenance and the procurement of cash spare and replacement parts and maintenance services; the transmission of cash certifi-cations and referenced documents to package users; and the development and implementation of cask operat ing and maintenance procedures and instructions.

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POLI C I E S AND PROCEDURES Maintenance Supercisor Responsibilities include direct oversight et cask m a i r. t e n a n c e and the procurement of spare and replace-I ment parts.

Managar. Systems and Eculpn.ent Design Responsibilities include the oversight of design dra f ting personnel' the initiation and review of drawings, specifications, calculations. and the test procedures, the prepara t ion o f S a f e t:.

inalysis Reports and Topical Reports, the review and disposition of nonconformances, the review of special test results the development and implementatior of Engineering pro-cedures and instructions.

Engineering Project Group Manacer Responsibilities include management of Radwaste Solidification System Projects.

Field Projects Manager Responsibilities include the oversight of Field Rad-waste Packaging Services.

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POLICIES AND PROCEDURES SECTI?N 3 DESIG.; CONTh_C L 3.1 General The H?.DC Quality Assurancc Progran, provides a s s u r.. r. c e that applicablc design cri t e ria are cc rrectly t ranslat ed into speci fi c at :ons, drawings, procedures, and instruc-tions.

The essential e l e n,e n t s requ: red in these design de c urre n t s affecting t he quality a d so:ety of HNDC s y s t c n.s are i mp l enx n t e d in seco:_ance with this section.

3.2 Responsibililv.

HNDC has the ultimate responsitility for controlling design activities affecting its product l!ne.

The HNDC Engineering procedures and instructions for drafting /

design and design cor. trol activities will detail this responsibility 3.3 Desien Criteria 3.3.1 Design criteria -elated to the safety and quality aspects of HNDC's products as re-flected in the applicable code, customer contract documents, and Federal Regulations are essential elements of HNDC design cont rol.

3.3.2 They are incorporated into the design by specifications and drawings.

Review of the specifications and drawings by uther than the original designer and final review by c u s t on.e r 's technical staff (when requir"d) provide the assurance that the proper de<,ign criteria have been incorporated.

3.3.3 Variations in criteria of project contr,lled arawings and speci fica t ions as dictated by t he cus t onier will be ident i fied and cont rolled by the Project Manager in accordance with Engineering procedures g< >ve rn i ng des i gn and document runtrol 3.4 Drawings and Specifi ution Controls 3.4.1 Control of drawings and specifications, and revisions to, or deviations from, drawings and speci fica t ions is the responsibility of Quality Assurance Manual HI;DC-C-001 5

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POLICIES AND PROCEDURES the Vice President of Engineering and is delineated in system Engineering Procedures.

3.5 Engineering Approval 3.5.1 Engineering approval is required fer all changes to, or de'riations f ro:r. dracings and specifications.

The Vice President - Engi-neerin;, or ais delegated representatlie, exercises this approval by reilew of drawings and speci fi ca ticns.

3.5.2

\\pproval required in pro,ect contrelied drawings and cpecifications, as dictated by the customer, will be made only by the Project Manager in accordance with Engineering proce-dures ;;overning design and decu:.ent control.

3.6 Selection and Applicability of Materials 3.6.'

selection and applicability of materials, parts, equipment, and processes related to the safety and quality of HNDC product lines shall be strictly controlled by Engineering.

The design control system requires careful selection and application of materials based on past experience, material testing, and compatibility with the application.

3.6.2 Where there is a special technical need or material application that is not within the capability of t he HNDC organization, consul-tants will be engaged to resolve the problem.

3.7 Design Reviews 3.7.1 Design reviews, alternative calculational methods and/or appropriate testing programs for verification of design adequacy will be conducted or delegated by the Vice President

- Engineering to suit the application.

3.7.2 Alternate calculations wiii be perf<,rmed by use o f hand ca l cul at ions independently checked by another engineer 3.7.3 Test. programs for the verification of design integrity may be required and wilI be approved by the Engineering supervisor after appro-priate design review of the subject.

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POLICIES AND PROCEDURES 3.7.4 1hc vc ri fi ca t ior, o f design checking proce cs is conducted by persons other than th orig-inal designer E a c h doc un.e r. t cerified ir, this manner will have the checker's signature or initial in on to the dm ign"r's 3.8 Desgn C h a r. g e s 3.E 1

!>e s i gn c ha r.ge s are controlled in the same nar.ner as the original design. and shall be made in accordanc with the engint" ring design and engineerir.g doc un er.: control procedures, 3.E.2 Tht ilNDC Fr4 i ne ri n C h a r. p

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s nee r i n g Char.ge E ;uest S y s t e:r w ' ! ! be ust; to c or.t ro l a nd do c un.e r.t all design changes.

3.8.3 Eeference copies of drawings will be n.aintained in the " aster Design File.

3.9 Design Control Implementation 3.9.1 The provisions of this section are detailec in subsequent sections spe c i fi c al l:, dealing with design control procedures.

3.9.2 Review of procedures implementing design control measures will be conducted by Systems Engineering.

3.10 Verification of Compliance 3.10.1 The QA Department will verify compliance with this directive and the offectiveness of established procedures by means of periodic audit.

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4.1 General

The liSDC procu rement documsnts include criteria and requiraaents pertinent to supply a satisfactory, derer.d-able, trouble free product.

The review prior to the p l a c en.e n t of the purchase c rde r, ensures that the necessary code c on.p l i a n c e, d e s i :;n bases, cl:ent s; ;i fi-cation requirerents, and regulatcry : equ: ren:er t s are included.

4.2 Procure. ment Docun en t s :

4.2.1 A Purchase Et ;u:sition (IR) will be developed from the client s specification and/or appli-cable HNDC design documents.

The Director of Marketing and Projects and the Quality Assurance Manager will review a PR before it is submitted to Purchasing.

4.2.2 The Purchase Order (PO) will be developed using the Purchase Requisition package.

The Material Control Supervisor awards a contract, purchasing the item f rora a supplicr on the Approved Vendors List.

4.3 Procurement Document Review 4.3.1 These documents are reviewed by the liNDC Quality Assurance Manager to confirm the accuracy and adequacy of the quality references and requirements.

The purpose of the review is to d e t e ria i n e that: (l; quality requirements are correctly stated, inspectable anJ control-lable, (2) there are adequate acceptance and rejection criteria, (3) the documents have been prepared, reviewed and approved in accordance with quality assurance procedures, and (4) that changes and revisions to procure-ment documents affeeting the quality assurance program are reviewed and approved at the same scope ano dcpt h conanensura t e xith the original document.

" Purchase Requisitions' are re-viewed for vendor selection and that the documents required for certification of the material to be used are included as a documen-tation requirement.

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POLICIES AND PROCEDURES 4.3.2 The technical content of precurement d ocu:r.e n t s will be reviewed by the Engineering Group and approved by the 'c i c e - P re s i d e n t - Engineering.

4.3.3 The H!;DC Prej.:c t Manager will be responsible for collecting and resolving 'in-house' c o:n : n t s on H:;DC documents

,$s well as vender pu rc hase docun.en t s ir accordance with H!;DC procurement and engineering docuraent control procedures.

4.4

'Jendors and Subcontractors 4.4.1 Purchase docurents for sater', and quality related itens will require H:;DC 'endors and sub;entractcrs to provide OA progran.s and procedures to the extent r.e c e s s a ry to coa. ply with requirements o f H';DC 's pu rchas e order documents and with any Federal Regulation.

4.4.2 H!?DC will reserve the right to review the vendor or subcontractor's purchase orders to its suppliers and will so indicate this requirement in the HNDC purchase order.

r Quality Assurance Manual HNDC-Q-001 5

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POLICIES AND PROCEDURES SECTIDC _5 CONTROL OF eURCHAS:'.? " TEh ! AL,

EOU ' !"ENT U:D S !* ', b U

5.1 General

Measures within the llNDC Qual:ty Assurince i ro; -a:r aSsu r<

that purch1se ma t e ri a l, eq u i pn.cn t and e'-' ices shall conform to the procu ren.en t doce nts uch c

measures a r t.

taker. before and after

-'Euatice T

'he p TC; a rem ;t docuDents.

5.2 Precurement Documents:

5.2.1 Procurement documer.ts consist of wecifica-tions, purchase orders, drawings, procedures, and, if applicable, an Encineering and Quality Verification Documentation Requirements (EQVDR) Form for the purchase of an item.

The EQVDR specifies supplier docume: _ation submittals.

l 5.3 HNDC Purchase Order Requirements 5.3.1 The purchase order requirements (e.;

Painting, Cleaning, Packaging, Welding, etc.)

.my be imposed on HNDC subvendors by one of the following methods:

i A.

Subvendor F> 1 a r@ e t Acceptance of the u

Requirement In the event that the subvendor agrees to supply equipment in accordance with the applicable HNDC technical standard and/or the stated requirements in an REQ, then a copy of the procedure is referenced in the vendor /HNDC purchase documents.

B.

Subvendor Submittal of Equal Procedure In the event that the vendor has an established shop procedure which fully satisfies the HNDC requirements, then HNDC will review his procedure.

If it meets the HNDC requirements, the vendor procedure sha11 be implemented in 1ieu of t he HNDC standard orocedure Quality Assurance Manual HNDC-O-001 5

YtiLE N U M 6 E li FEv

'-230'51-

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POLICIES AND PROCEDURES C.

Quality Verification at HNDC In the event a vendor cannot conduct the required quality control testing or examination at his facility, then HNDC shall have the option of either conduc-ting the required tests, t x an.i n a t i on s,

etc. at H?;DC facillt:es. or to conduct these tests at another HNDC designated subverdor sh?p.

D.

Standard Parts In the e'. e n t the s Wcendor standard product meets all requirements. tF"n H'.DC's Enginet ri n g shall r-

-i n th docun:ents describing this ;.roduc t.

'Jpan approval, the HNDC perchase s g r e e n.e n t with the vendar shall only include the description of the standard product.

5.4 Source Evaluation Conducting of source evaluations to determine objective evidence of source quality, contractor performance and the delivery of a Quality Product is the responsibility of t he QA Manager.

5.4.1 Source evaluation of a vendor is determined by a vendor survey The survey determines the capability of the vendor to perform to the designated quality standards.

It provides measure of t he vendor acceptabilit y to the a

"Quali fied Vendors List", for the appropriate item or service.

5.4.2 Evidence of source quality and vendor per-formance will be determined by inspection reports of visits made to the vendor, audits made during the visit, or by previous approva) of his services or equipment.

5.4.3 Quality on delivery will be determined by

>hy s i c a l inspection at HI;DC or by a receipt inspection report made on delivery at point of destination.

^i Quality Assurance Manual H1;DC-O- 001 5

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POLICIES AND PROCEDURES 5.5 Periodic

'.s s e s s m e r. : of Vendors and Subcont ractors 6.5.1 These vendors or subcontracterc qualified for inclusion on the

'.\\pp ro ced Vend < rs 1.ist" wil]

be requalified periodically The C/ Mar. age r will deternine when : e q u., l i f -

cation of a ',endor or subc c.n t rac t o r is rec;L i ed.

Generally, no longer than two years shall elapse between audits.

5.6 w 'facturer's Ftandcra Eauirment Yn e T-3 pu Chiced :!er iS a c*andard, D ' n - F a f t' ! y r e l d t t t.,

o f f

h e - s h e l f p rc..d u c t, the 'cendo: nm-bt qual.fied thre;;h the use of a Ouclity F.a t i n g s v s t en.

F.is sys<cn. w-ll receice input trom the Q u a l i t :, issurance Venas: S u r'c ey F o rn:, supplier and internal non-c on t o rn.a n c e reports, and receipt inspection reports.

receipt inspection will be performed on all items.

The Quality Rating System will be detailed within H.NDC C;uality Assurance Procedures.

i Q u.a. l i.t _yA s s u.r_a.n c_ _e_ ::a n u. a l--

HUDC-O-001 5

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POLICIES AND PROCEDURES SECTICS 6 IDENTIFICATION AND CONTROL CF MATERIAL, EARTS, AND COMPO![ENTS 6.1 General The requirements far identi! tat 2on and control of material, t>a r t s, and components w.ll bt :mplemented by INDC. it-eendors and subcentractors.

The methotis and systems u'ed for identification and control will be developed frm. cl:ent spe c : :. c a t : r.n s and Fede ra ! W ;ul a-tions The v t n t - O u b e r. t : a r t e r 1,' be audited du: inn thc fabrication of th( ;roduct by liNDC to enrure com-pliance with his e s t a ol i s hed p ro c ra:t,

6.2 Identi fication of Materials:

6.2.1 Materials, parts and components including partial assemblies shall be identified and controlled as specified in purchase docu-ments.

HNDC shall define this requirement and require vendors and their subcontractors to identify their equipment and material in a similar manner.

6.2.2 The HNDC Project Manager and QA Manager shall assure, during their review of purchase docu-ments, that requirements for the ident i fica-tion and control of materials, i f applicable, are specified.

6.2.3 The correct identification of materials, parts, and components will be veri fied and documented in accordance with Quality Assur-ance receipt inspection procedures prior to release for fabrication, assembling, and installation.

6.3 Traceability-6.3.1 The identi ficat ion of mat erials and parts import an t to the function o f sa f e t y-rela t ed systems and components will be maintained so as to be traceable to the appropriate documen-tation, such as drawings, specifications, Quality Assurance I:anual HNDC-0-001 5

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ilTLE NUMBER 8EV

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POLICIES AND PROCEDURES purchase orders, m anu f ac t'. ring and inspection dccuments, deviation reports, and physical and chemical mill test reports.

6.3.2 The locat ion and me t hod of ident i fication will be ca:efully detern.ined so that the fit, function, and quality of the item b e i n ;',

identified will no* be af'ected.

6.4 Identification Throuch Fabrication and Ins t alla-ion :

C41 Idert fication of c.SME Code tra te ri al durin fabricat:en, erection, installation and u '. t i n.a t e use will be as specified as ASME

Code, 6.4.2 Noncode material is ider.tified and cont rolled in accordance with H.NDC's purchase document requirements, or the vendor / subcontractors QA procedures used for non-ASME Code items.

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POLICIES AND PROCEDURES 7.4

" Reject" and " Hold" Status of Equipmeat:

7.4.1 Equipment in a "Eeject" or "llold' sralus shall be handled, stored, or in tne 'asc a Eisl: a :: i :

I manu f ac t u red items shipped on or dcscribed in Section S to !!';iC o r ano t he -

subcendor fo: disposition shall bt in a c 'e r r d -

anct wit h ';>ee: fica t ion reqairements.

A "Eeject" cr "llo l d ' status does not,lter any responsibility in the handling, s t o r ; n ;;, or shipping of the equipment, I

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Ouality Assurance I:anual HNDC-O-001

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POLICIES AND PROCEDURES SEC'Il0S b NONCONFCPJ!ING MATERI ALS. PARTS OR CO!!PONENTS 8.1 General.

Noncon forming materials, parts, and components, shall be controlled to prevent their inadvertent use or installation.

S.2 Cont rol of Nencon forain; Items.

S.2.1 Noncor.formin c i t ems shall be identified and rigidly controlled for all safer and quality related items.

Items not conforming to specifications and drawings are tagged " Reject" or Hold" with controlled tags issued by the QA Manager.

These items cre not to be used unless cleared by appropriate formal dispo-sition, and the " Reject" or "llold" tags formally removed by the Quality Assurance flanager.

S.2.2 The acceptability of rework or repair of materials, parts, components, and systems is veri fied by reinspection and retesting the item as originally inspected and tested or by a method which is at least equal to the original inspection and testing method.

L S.3 Supplier Nonconformances:

8.3.1 Deviations or nonconformance to liNDC specifi-cations, purchase orders, drawings, and procedures shall be reported by HNDC's contrac-tors or subcontractors to liNDC, via a Non-conformance and Deviation.7eport (N&D).

8.3.2 For the nonconforming item, the vendor or subcontractor shall desc ribe the noncon-formance preeisely, and recommend corrective action including an alternate solution.

Qualitv Assurance "anual HNDC-0-001 5

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POLICIES AND PROCEDURES 8.3.3 A vendor or subcontractor n.ay elect to use his own NiD f o rn., provided the information thereun is substantially the same as that on the HNDC form.

8.3.4 nere there is a nonconfermance, the vendor cr subcontractor shall attach a "Eeject" or

" Hold' f o rr: to the i t en: and ensure it is not remcved "nt..

disposit.cn has been made.

8.3.f A " Reject' or "Hald" tag is used by HNDC when the item is nonconfo: ming and needs cor: ect. t action.

A "Eeject" or "!bld" tag is also used te inli.: ate that additional i n f e rr..M i o n or docu 1c.tation is weced to fulfi]l the purchase docucent requirements.

An N&D submission is not necessarv for this purrese.

The " Hold" tac placement, removal anc th(

resulting corrective action will be documented on the QA Receipt inspection Form.

8.3.6 N&D reports chall be forwarded to a cognizant HNDC Engineer for disoosition.

8.3.7 Dispositi<n may take the form of Acceptance',

Scrap; Repair; or Modify S.3.8 l'pon comp e tion o f the disposition and the N&D form approved by the cognizant Engineer, the QA Mar iger and the Project Engineer, the form wil1 e forwi.ded to the Materia 1 Control Department Copies are maintained in the P roj e c t. Mast r File, QA File and Purchasing Master File.

8.3.9 When correcti e action is completed, an item will be consiaered ready for inspection.

HNDC will res rve the right to inspect the item for compliance with the N&D report disposition.

The QA Manager shall verify that the action has been properly completeo and will sign off the N&D form.

I f the action is mt correct, anoth.r h6D report will be is<ued citing the additional "Noncon-formance e: Deviation" 8.3.10 The HN.

'ns, etor will forward copies of t he completed N&D form to the HNDC QA Manage r for record retention.

Quali ty_As s uranc e__ Manual..

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POLICIES AND PROCEDURES S.4 In t e rna l ' cnc on f o rr.ances H?!DC noncor.f e rn ances to specifications, purchase orders, drawings, p:ocedures, or instructions wil1 be documented on a corrective action notice form.

Issuance and completion of this f o rn. Wi l l be n.onitored and con-trol]od by the Quality 'ssurance ':anager in accordance w.th Quality Assurance Procedures.

S.5

_Eisk Eeleased t e m _s_ :

7 S.5.1 In the e,ent that the project u.a n a g e r is requested te shi; an i t e.m b:. the client without p re;;e r %cumer.t a t i c n or w:tb a q u a l : t.,

rel st ed de f: it nm. he shall i".it:ste a E i si:

Ee.ecse nisis fers for appro'11 by the Quility issurance Lt.ager and Director of Marke*ing and Frcjec ts.

o.5.2 The Eco;ect Manager shall sign the release and submit sanie to the Quality Assurance Bianager for his review and approvals as indicated in Section 8.4.1, 86 Rish Release En f o rc enien t 8.6.1 In the event of an item being released on a risk basis, the Quality Assurance fianager or his designated alternate shall assure that the condition on the Risk Release is en fo rced.

'ib e n all the conditions are resolved, the R sk Nele.ise will l'e cleared and a copy forwarded t o !!a t e r i a l Control Supervisor, Project flanager and Contracts Administrator.

_ ___Q.uality Assurance I:anual H::DC 0 01 5

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e-649 IM

POLICIES AND PROCEDURES SECTION 9 COEEf.CTIVE ACTION 9.1 General Measures within the HNDC Quality assu:ance i rogra assure that conditions a d v e r :: t to quality are p:ci4tly identi fied and corrected in a timely taanner.

Tne responsibility for implementir.g ccrrectise action systems rests with the QA Maager.

9.2 Iden t i fic a t ion snd Cer ection:

The alits i.s su rance Mana s;e r is resnensible for ensur-g inR that Conditions adverse IO a quTlity prGGuCt Cu2h as d - i a t i C P. s, n o " C o r. f 0 rI W 9 C e s, d0fective itemF. T I S 'r; re}. ease items etc., dre identified and appropriate Corrective action is taken.

9.2.1 The principal source o f quali t y d< f ec ts identification is the Nonconformance and Deviation Report, the heceipt Inspection Form and the corrective action notice.

The QA program shall ensure appropriate distribution for all document s reporting quality problems and shall iden ti fy the action necessary for correct documentation.

9.2.2 The QA Manager will review all nonconformance reports for accuracy, completeness, and assignment for corrective action.

9.2.3 Upon c ompl e t. i o n of the evaluation and dispo-sition of N&D Eeports, the QA Manager will again review the report for completeness of corrective action and ensure that the assigned authority has approved the disposition.

9.2.4 The QA Manager shall ensure that I,3 D Repo r t s receive proper ei;iiu;111on and d i sl>o:,i 1 i sin wiihin a reasonabie iime Those dispositions lio t resolved in a 1imeIy I ash i < >n wi!I lu brought to the a t t nt ion of Ihe Director of 1:ngi neering and projects.

Qu a l i t y Assurance !!anual H::DL-Q-001 5

TITLE NUM6ft TEN

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POLICIES AND PROCEDURES 9.2."

Follow-up revieu:, will be conducted to cerify proper inipl emen t a t i on of correct:ce actions and to close-out t h e.N o n c o r. f e rm a n c e and Dt i a ted fiepo rt s, Corrective Actior. Eeports, and Receipt Inspection Forms.

9.2.6 In the even: of an iten. bcing released en a risk basis, the Qualit:, Assurance.'!anager or his designated altern at e shall assure that t ie conditier or the :.i s h h e l e a s,e

.s enfo:ced.

Wh~n all the conditions are r c s o ! ', e d, the E;sn Release will te cleared and copies forwarded t o 'ia t e ri a l Con t rc l. th( c o g r. i z a n t P-o;ect.ian c ee r, a r.d C o r. t : ic t s i.da i n i s t : a t : c r Quality Assurance !!anual H"DC-O-001 5

TITLf HUM 3[t t[y

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649 157

POLICIES AND PROCEDURES SECTIU:i 10 INSPECTIOi 10.1 General.

The inspection function is pe r fo rmed by 1:NDC, vendors, and subcontractors and will be pectormed in accordance with an inspection plan.

Vendors ind subcont rac tors will be required to establish and follow an inspectton plan as required by regulatory and/or client require-ments and by the compl e:< i ty o f t he material, part, or component and its relation to sa fe t y 10.2 Inspection Areas:

10.2.1 Inspection and monitoring areas are defined in the inspection plan and procurement decu-ments.

10.2.2 Inspections and/or audits, as applicable, will be conducted by the QA Manager or his delegated representatives.

10.3 " Hold Points"-

10.3.1 Inspection ' Hold Po i nts" may t> e designated on t h e.

pu rchasing documen t s, EQVDH o r in the controlling procedure in accordanc-with the applicable inspection plan.

'4o r k w i l l not be continued until a Q:' re r re s e n t a t. i s t witnesses or releases th._

particular ' Hold Point.'

10

).2

' list of ' Hold Points" w t :1 b-

nsertul ny tnt cognizant Projtet %nnet in the 4peci-ficat;cn, controlling proce.iu;es. and/o:

ourchawing documents.

I'hese wili at reviewed by the Q.A '!a n a g e r.

10. + Iadep ?ndence a f 0.\\ a n :1 Pre!uction Personnel i

10.4.1 HNDC's policy is to provide fo r the separa-tion of the interests of inspection and production personr.el in all aspects of the QA Program.

Inspection personnel will be independent from the individuals p e r f o rm ing the actisity being inspected.

.._. _- _ Q' :a l 4 ~ m ~rce Manual HSPC n-001 5

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POLICIES AND PROCEDURES 10.6.2 Vendor r.uppl:ed items shall be inspection accepted by the vendor's inspectors who are not assigned to a production department or other group that e.ight influence the dacisions of the irspector.

10. 4. '.

IP:DC will assess the relationship of inspcetion to product:or or operatior,s activities by r.-eans of audits / inspections.

10.5 "STOF w3EE' Crder 10.5.1 The Q/ Manager and/or his Jelegated repre-sentative u. a y :nstitute a

'S t c p Wc rk" orde r,

based or a r-uns a t i s f ac t o rv eport. test wit.essing, audit, cr routine s u m t. l l e r. c e It shall be tne responsit ili ty of t he QA

" anager to prc. :de the Director of Eadwaste Disposal and Support Serviccs with the details pertinent to the "Stop Work" act:en for his review and approval.

This must be accomplished as soon as practical after the initial "Stop Work" order is initiated.

Where t i rn e allows, this review and approval shall be accomplished prior to the issuance of a "Stop Vork" order 10.

.2 Restart of work will depend on the satis-factory correction of the deficiency and documented by complction of the Nonconformance and Deviation (N&D) report, reporting the deficiency 10.6 Evaluations:

10.6.1 The N&D report will be dist ributed to the appropriate personnel 10.6.2 The QA Manager will review distribution lists to verify that the concerned personnel are receiving the N&D report.

10.6.3 Comp l e t ed NAD repor t s wiil be r<ciewed hv ihe QA M.m. ige r Ior compii.mee 5

-- _ __ _ Qu a l i t y Assurance Manual HNDC-Q-001_

..ci y c, a flTLE NUutta atv

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POLICIES AND t) ROC EDURES 10.7 Inspection of Modificatien,. Repaire., and Replacemer.ts Mod i fi c a t ion.=, repairs, and replacen:ent s will be inrpected in accordance with the original desi;;n and inspect:on re qu i ren:e n t s or acceptable alternatives-

10. 8 O u a_ l i f i c a : i o r. s :

n.

Inspettors >ilI be qualified in acc'rdance w:th t h.

HSDC Ouali t: Assurance ira:ning I' r n g r e.r.i.

This progran.

will i n : e r;.o ra t e the rc qu i ren1er t e o f appl: mable regula-t:ons, c o d.. *, and standards.

Docunie r. : s suptsorting this trainir.g

.11 be filed and kept current 5

_Qualit Assurance !:anual H"DC-0-001

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POLICIES AND PROCEDURES SECTION 11 TEST CO,I ROL 11.1 General-Tes t ing of }{ND supplied equipmen t is conoucttd in vendor or subcontractor shops or UNDC facilities in accordance with prescribed test procedures, or s p ci f1-cations.

Tests may be witnessed or audited by l!NDC representati..s and, where necessary. t h..

results evaluated by a cogni: an t liNDC engineer-

11. 2 Fabri c a t ion Tes t s :

11,5.1 In-prN ess and firtal tests will be perin: me '

as required by specifications, drawings, and applicable codes.

'Ihese tests will usually be performed by a vendor or subcontractor.

11.3.2 Tests conducted in vendor or subcontractor's shop will be witnessed, inspected, or audited by the HNDC inspector in accordance with the i

applicable inspection plan.

In the case of "llold Point" tests, the llNDC inspector will witness tests prior to the continuation of production.

11 3.3 IINDC wi11 be not i fied of t he schedule of fabrication tests to be performed in accordance with the contract requirements.

11.3.4 Preinstallation test results will be recorded by the vendor and/or an llNDC representative /

inspector and forwarded to the llNDC cugnizant engineer for evaluation and disposition.

11.4 Preoperational Tests (solidification svstem only) 11.4.1 Preoperational tests aro typically conducted by the ultimate user.

IINDC assists in the performance of these tests as rcquired.

11.5 Operational Tests (solidification system only):

11.5.1 Operational tests are typically conducted by the ultimate user.

HNDC assists in the per-formance of these tests as required.

Qua_lity i s sui.anc_e_ Manual HNDC-0-001 5

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pol i C l[ 5 AND PROCEDURES 11.. t lest contro:

ll..c.1 l'

icc tv l'N X t e s - ' t.g a p r oc.-du re of suffi-t: r -- t d: tail w 21 t, : developed by a :enn :..an t

! P. !)C < r. g i n e e r.

In l u ;' e d in

t. h i s procedure will c..

a:cep'ar.ce.i n d reject:o: triteria or e r. t th.,.

tk test results be revuvdJ and appro d

y thc engineer prior to a c ; - p t a r.c t 11.6.2 Fr: c to

e s t i r. g by 1

! vendor, the test pro-c t du re, as c-quired

- the p r o c u t. :u n *. dncu-n.e n t s,

,'i1 te subu :ted for review b, HSD e n r. i. ' r i r. 5 L

f this procedu: t w: ll i n c l.'.

2,. n r ce,.1 acc.ctance, re cetier,

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c-it-r:a r set-i t si

.,f ttst results t o H':D; e n g i n e t ri n;; for ac rc~al.

c 11.6..

"odi f: c a t :ons, r c.

rs, and rep'acements wil.

he tested i r, ac c > rean, - w: th the original des cu and t e s t : n;; requi remen t s or accepta'le a l t e rn a t i'. e s.

.11.7 Syecial Testing:

I 11,7.1 Special t e s t i n;; o f onponents or equipment and the type of tes ing to be conducted will be as defined, on a case basis, in specifi-cations.

11.7.2 The HNDC engineering personnel will witness special tests, review the documentation, and evaluate the results.

11.8 Enrineerinc Evaluation:

11.8.1 In special cases where an actual test cannot be performed, i.e a destructive test, engi-noering will determine through mathematical "va l u.i t i nri the adequacy of the design para-Ih(' I a

r H quality Assurance ".anua HSDC-Q-001 5

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POLICIES AND PROCEDURES S_ECTION 12 INS"ECTION, TEST. A!;D OF ERATING STA f L'S 12.1 G.:n u r a l.

HOC w;11 n.ain t a in a sn t em to indicate the =tatus of

~

inspection and'or test requi t enn nt s of indi'aidual components and equipment within t h.: sco; t of the OA program 12.2 5tatus of Sys ems:

12.2.1 Fruus a: :nspection er tests f indis iacal c < " r.o r. c n t s a r. c e q u i ;.c+ r. t will be naintained and k.;pt current.

12.2.2 An identification system u.ay use a tagging er color coding process.

In the case of ASME Section ill work, the " traveler" system will identi fy each stage the item has passed and the inspection performed.

12.2.3 Records of inspec t ions performed (e.g.,

receipt inspection, shop tests, etc.) will be filed by the QA Department.

12.2.4 Records of vendors or subcentractors tests and inspections will be maintained by the vendor or subcontractor until the equipment is shipped.

Where radiography is rec,uired or speci fi ed, radiographs will be maintained by the vendor or subcon t rac t or pendi ng cus t on.e r disposition in accordance with applicable code requirements.

Qualit, isssurance Manua HSDC-0-001 5

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POLIC L ES AND PROCEDURES SLCLIO!; 13 CG!;Ih0L OF ?!!..\\SUh!!;G A?,D TEST EQUIPME!;T 13.1 G e n c r__a l.

Measuring and test equipna nt a r.

cont nlled

+e Each w:1. bt : der.t : f ed by a cerial nun. bet and sti_her indicating tlc calibratinn status and will be issued on1s by th* Qua!it.s

.ssurance Manager.

13. 2 Cali t ra t :on '

Th.

talitrat:en of ne a su ri:.L anc t.-t eqa:imcnt wil? ne Der #'rC,d annull.y Or mOre [roquen t } ',

.[

r e c o r.r - n d e d Ev the e q u i r r.e n t

.anuticturer-Th. calibration < Pall be perferncd with stant ris traceable to the ?;a t i on al Sur au of Stardards.

?;o item will be issued w:th?ut a current calilration sticker.

The calibration period of a measuring or test device ii.ay be allowed te expirt if it is not expected to be used for an extended period of time.

However, prior to the next use of this item, it will be calibrated.

13.3 Maintenance:

If controlled equipment is damaged, dropped, or if the user becomes suspicious of damage, use of the item will stop immediately and the calibration will be verified.

13.4 Documentation:

Calibration test data, traceable to the equipment by serial n un,be r, w;ll be n,aintained and 1iled.

1 o r, will be maintained to document usage of each controlled item so that in the ever.t it is found to be out of calibration, usage may be traced to inspected items.

These i t en.s will t a gt;e d immediately with a hold tag and reinspected with calibrated equipment.

A corrective action notice (see Section 8) will be issued i nan e d i a t e l y t o H!:DC engineeri ng, which will evaluate the condition o f t he suspect items.

If't is determined that a discrepant item could pose a sa fety or installation p rob l en. and the item is in use or has been shipped to the customer, corrective a tion will be taken as 'ollows:

(a)

If the coa.ponent is being operated t'y H:;DC (trans-portation casks), use of the item will stop imme-diately until the item is reinspected and either found to be acceptable or repaired and retested, if reaui md.

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POLICIES AND PROCEDURES (b)

If the compenent has been shipped to the customer fer hic ownership and use ( solidi fica t ion system equipment), he will be notified immediately, in writing, of the discrepancy Due to the long shipping, storage, installation, and testint ~

period for this type of equipment, it is highly "nlikely ti..i t the suspect i t e", wo u l d b e in-se:,1ce p ric r te discovery of tbt calibration discrepancy if tb r.

is mv question, the customer will Le notified by telecon with a tollow-up in writina.

The complctiu. ef the abe ce ccrrect n e action will be docur.

.tec 3r the correct 1ce a:ticn notice form, i

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POLICIES AND PROCEDURES S ECT 10:, 14 CO.';ThCL OF SPECI/d. FROCESSES 14.I General-Wher required by applicable R(gulaterv, C u s t :,n e r,

and /o r li!,:R Eequirements, spec i al ;'ro ce c s c s, f r. c l u d i n g welding, n o rnh s ructive erm i r.a t i on s ' DE i and hc at trea!ing. Will be per[Ormed in 3 C C ird,:n C e With Wri!ttn procedur05 Th e n kill be developed in aCCordance W: th appli2abl/_ " ^ '-} e S, standi JE, or other r e q u i reir e n t s and paracraphs l '. 2,

14.1 ana 1/.4 will

'>e a p :> l i c a b l e 4

14. 2 F e r c,'m r. e l Duall:: cations'.

i' e r s on n e l pe r [O TTCi n Specia} procesSeE Wil} bt Qual [ieC for that process in accordance with the requirements of i

I the iS.'!E Loiler and Pressure Vescel Code, the /ce ri c an Welding Society standards, S ?,'T-TC - 1 A, or as required by another applicable code.

14.3 Procedure Qual i fi c a t ions :

Special process procedures will be qualified for its application in accordance with the requirements of the AS!!E Boiler and Pressure vessel Code, the Arne rican Welding Society standards, or as required by another applicable code.

14.4 Records:

The qualification records of procedures and personnel associated with special processes will be established, filed, and kept current.

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POLICIES AND PROCEDURES SECTIC!: 15 INCTEUCTIONS, PROCEDEES AND DE.WINCS 15.1 General:

Activities affecting quality are cor.t rolled b: doc un.en t ed instruct: ens, procedures or drawings of tv es appropriate to the circumstances.

15.2 C_uality Activ. ties:

15.2.1 Documented instructions perti..* to safety and quality tlated it n.c in lu nc cri teria bE1CD [O r" th.e ba$iS [Gr accu pta: Je. w.11 be prepar?d in acCordance with Document Control I r o c 0 d '.; r e S.

15.2.2 Requirermnts incorporated into H.D.: instruc-tions, procedures, or drawines are, where a pp l i c a ta l e, ir. posed on cendors end subcontrac-tors to the extent necessary to insure com-pliance with the contract requirements.

15.3 Document Procedures:

15.3.1 Instrue' ions, procedures, or <!rawings for sa fety and qualit y related ac'i'ities are described and implemented in he following documents, a.

Procedures Quality Assurance (QA)

Procurement (Material

.ontrol and QA)

Adn.inistrative ( M a r. ger,e n t and Engineering)

Design Control ( E rig. n e e r i n g )

Engineering Documen. < < /, t r o l /Engi-neering)

Operations Prc o

Maintenance P.

.et

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t POLICIES AND PROCEDURES o.

Drawings and Specifications HSDL originated (Engineering)

W ndor and Subcontractor supplied (Vendor)

Custon.e r supplied (Cilent) 13.4 r recedure Ee,;. ew:

15.4.1 The CA Manager.,ill be responsible for re,iew of procedures affecting HNDC Quelity act:vities.

TFes.: procedures will be prepared by the responsibit F e c t i o n 'b.r a g e r s.

15 a.7 Th e Q/

ar.a ge r w: l l be responsible for insuring that the Q/ n.inual and procedures reflect current QA practices.

He will prepare or reconunend revision of procedures as necessary L

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POLICIES AND PROCEDLRES SECTION 16 DOCUMENT CCNTROL 16.1 General:

Control of the issuance o f docu:aen t s and changes thereto wnich af fect quality is an integral part of the HNDC Quality Assurance Program.

16.2 Docurent Centrol 16.2.1

's t ri fic a tion o f comel:anc e wi t h the docuatat cc>ntrol procedures is the responsibili:', of the 0.s Manager.

De p a r t n:en t Managers w111 establish the re.qu: red documen t cor. trol procedures, and the QA Mmnager will moniter their implementation, and audit the systen.

16.3 Document Changes and Revisions:

16.3.1 The same organization and system, as used for the original issue of a quality and safety related document, will be followed for all revisions and changes to such documents.

16.3.2 Review and approval of document changes will be performed by the originator or other equally qualified designated reviewer.

16.4 Controlled Documents:

16.4.1 The Quality Assurance Manual, Manual Addenda, and designated Quality Assurance Procedures are controlled documents.

16.4.2 For sarety and quality related items, as a minimum, the following documents are placed in a controlled status:

(a)

Specifications and/or Drawings (b)

Purchase Orders

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POLI C I E S AND PROCEDURES S ECT I C:. 17 QLALITY ASSURANCE RECORDS 17.1 General:

The objective of maintaining a record retention system is to provide an appropriate and easily retrievable quality history that will be available for each quality or safet:, related item.

17.2 Ouality Records:

17.2.1 HND: will maintain a master file for all quality ar.d safety related products.

This file will centain, but is not limited to:

(1)

Drawings.

(2)

Specifications.

/

(3)

Purchase orders.

(4)

Test and inspection records, Certificates of Compliance, mill certifications and other equipment documentation.

Inspection records will includ, receiving, in-process, assembly, final and packaging and shipping inspections when applicable.

(5)

Special process procedures.

(6)

Qualification records for personnel, procedures and special processes.

(7)

Training records for inspection and test personnel and auditors.

17.2.2 The QA Manager is responsible for periodic audits to assura that QA documentation has been processed properly and that specified inputs are part of t he historical record.

17.3 goality liecord Fi les :

17.3.1 The Master File of Quality Records consist s of the F urchase Order Mast er Fil e, Qualtty Assurance Master File, Engineering Master Design File, and Contract File.

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POLICIES AND PROCEDURES 17.4 Identifiable and Fetrievable.

17.4.1 QA/QC records will be filed in a manner that wi11 allow records to be readily identifiable and :etrie.st.lc

~

17 a.?

The QA Manager will b: responsib!t for assuring that standard < are estiblished including requirements for records and the maintenance of such records.

I 17.5 hetention of Records:

17.5.1 Eecords kept for retentitm will U m a i n '.i i n e d for ::. minimun-

r. r i od o f

:..c re ': ired hv a CUStOTer's p.;rch;.e crdt: or spec.:: cat.cn.

the appl calle feceral regulat. m.

or fc two years, i f rx o t h e rw: s e spec:fied.

17.5.2 Designated records (e.g.,

radiographs-may be stored at vendor or subcontractor facilit:es.

Such requirer.ents shall be clearly stated in the purchasing documents and liNDC will ex-ercise final disposition of all such designa-ted records, i.e, take possession of records at time of the shipment to be retained at HNDC.

17.5.3 (Transportation Packages)

Design related records (drawings, calculations, etc.) will be maintained for the li fe of the shipping package.

All othe: records will be maintained for a minimum o f t wo yea rs.

17.6 Protec tion of Records:

17.6.1 Protection and preservation of records as indicated in 17.3.2 will bt the responsibility of HNDC.

17.6.'

HNDC will maintain a Master File at the Columbia, Maryland headquarters.

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POLICIES AND PROCEDURES SECTION 18 AUDITS 18.1 General:

The audit is a me thod for de t e rn.i ni ng the effectiveness of t he Ouality issuranc+ P rog ran.

This will be accom-plished by reviewing,.- Jetail, selected areas of perforn.ance and cen.pa ri r.g the results with objectices outlined in this manual.

18.2 Enscheduled and Planned Audits:

15.2.1 H.E has a responsibility le-the ' a. p l t u r. t a -

t;en of its 0/ e ra r r an.

In order to exe rc i st th:s responsibility and <.dccuately control tht p ro g ra:n, unscheduled and planwd audits will be conducted.

16.2.2 The QA Manager is responsible for planning, scheduling, and conducting these audits.

18.2.3 The preparation of audit plans, reporting the results and infractions and initiating the corrective action is also the responsibility of the QA Manager.

18.2.4 Frequency of internal audits will depend on 1

va ri ou s fac tors including the criteria and seriousness of past infractions.

18.3 Audit-Checklists:

18.3.1 Audit plans will consist of selected checklists applicable to the area in which the audit is being conducted.

18.3

')

6 general list of attributes from Sections 1-17 are used as a guide in the preparation of audits.

15.4 Audit Teams:

18.4 1

'l he QA Manage r wi l l be responsible for assuring the technical competence of audit personnel.

Audit items will be developed using the expertise of personnel from specific disci-plines to provide the necessary ability

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POLICIES AND PROCEDURES 18. /. 2 Assignment of personnel to audit t ean.s wi l l re fl ec t the realistic independence of the audit personnel in relatinnship to the person-nel, area, or o r s.an i z a t i on being audited.

18.5 Audit F i n d i r.g s :

18.5 1 iudits will be conductc? using formal check-lists.

Infractions n:t.-d w 11 be d oc u:. en t ed.

indicating type and nature of infraction and its relative seriousness.

18.5.2 Upon con:ple t :en o f t he audit. the audit leader will conduct a critigas of thc findings to the organization bt i.; audited 18.5.3 A formal report will be sent to the appr pr. ate management le,els for action and will include the Direc tor of Radwast e L isposal and Support S e r' - i c e s, the Director of Market ing and D rojects, the Vice-President - Engineering, and the liSDC General Manager.

18.5.4 Management of the area audited will, by completing an audit reply form, will advise the QA Manager of the corrective action to be taken indicating a reasonable schedule of when this action can be accomplished.

18.5.5 Based on the results of the audit, the review by management and follow-up actions, the QA Department will re-audit the same area to deternine compliance with the results of the initial audit findings.

18.6 Audit Records and Schedules:

13.6.1 The QA Manager will maintain the official record of audits, findings, and actions taken.

18.6.2 The Q.i Manager will schedule, prepare, and maintain audits for engineeri ng, design, procurement, etc

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hit T M AN NUCLE AR DEVELSDf/. TNT CDRPOR ATION C Otuv e!4 aArvtadC 21C45 P O LICIE S AND P R O C E D U R E S QUALITY iS SUR.iNCE 'iANUAL.;%E?s u'Ju FCR TRANEP2:.IATIO, CAS!:S.ICENSEL UNDEE 10CFR FART 'l QUALITY ASSUEANCE v.!dUAI J.DDENDUM

( liNDC - Q- 001 B )

4 U.S. Nuclear Regula*ory Commission Doc ket 71-0024 Copy # 5 gg rescanse Qua'iny Assur6nce agij;igEr li::DC -O- 0015 0

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POLICIES AND PROCEDURES 1.0 Scone The Quality Assurance Program described in this manual (Procedure HNDC-Q-001) and addendum (Procedure HNDC-Q-001M, applies to the procurement, n,odificalion, u.a i n -

tenance, and use of transportation casks, certified by the United States Nuclear Eegulatory Commission, for use in accordance with 10CFR Part 71, 2.0 Quality Assurance Program A monthly review of the Quality Assurance Program will be performed by the Director of Eadwaste Disposal and Support S e r; i c e s to assess the scope, status..mple-centation, ano effectiveness of the pregram to assure that it is adequate and complies with 10CFR Fart 71

.ippendix E criteria.

3.0 Design control Design Control will be implemented in accordance with written Quality Assurance and/or department procedures to assure that; (1) regulatory and design requirements are correctly translated into speci fications, drawings, and procedures; (2) quality standards are specified in the design documents and deviations and changes from these quality standards are controlled; (3) desi'gns are reviewed to assure that design characteristics can be controlled, inspected, and tested; (4) designs are reviewed to assure that inspection and test criteria are ident i fi ed ; (5) when a test program is used to verify the adequacy of a design, a qualification test of a prototype unit under design conditions will be used; and (6) individuals responsible for design verifi-cation are other than the orginal designer and the designer's immediate supervisor.

4.0 Instructions. Procedures, and Drawings Instructions, procedures and drawings will be prepared, reviewed, approved, and controlled in accordance with department procedures which clearly delineate the sequence of actions to be accomplished in ecen step.

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POLICIES AND t) ROC EDURES 5.0 Document Control Controlled documents, and changes to them, prior to release, will be reviewed, approved, and issued in ac-cordance with written procedures to assure- (1) that they are adequate and that quality requirements are stated- (2) chat approved changes are included in these documerts prior to implementation of the change, and that (s) required documents are available at the location where the activity will be performed prior to consencing o f the work.

Controlled documents are further identified in para.

16.4.2 of the manual.

The current re,1sior number of instructions, procedures, s pec i fi c a t ier.s, drawines, anc procurement documents will be ident fled on a master list maintained by the responsible department.

6.0 Procurement Document Control Purchase Requisitions and Request for Quotation packages wil: be reviewed by the Quality Assurance Manager and the Directoc of Engineering, or his designee, as provided in procurement document control procedures.

Procurement documents will identify the applicable re-qui ements of 10CER Part 71 Appendix E which must be com, lied with and described in a Supplier's Quality Assut<nce Program.

Also icentified will be the documentation to be prepared, maintained, and submitted to the purchaser for review and app oval and records to be retained, controlled, and maintained by the supplier and those delivered to HNDC prior to use or installation of the hardware.

This documentation may include drawings, specifications, procecures, inspection and fabrication plans, inspection and test r2 cords, personnel qualifications, and material test reporr.s or certifications.

As a minimum, the furnished records shall include documentation; (1) that iden ti fies the purchased material or equipment and the spec: fic procurement requirements met by the items, and (2) 1. a t describes any deviation from the procurement requirtments and the disposition of the non-conformance

(" Accept As Is" or " Repair"),

Procurement documents will specify HNDC's right of access to a supplier's facilities and records for c m,,- c.,

.-m wa w ie QA Manua l. - A_ d d_en._ dun _ _ _

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POLICIES AND PROCEDURES 7.0 Control of Purchased Material, Parts, and Components The results of supplier evaluations will be documented and filed.

Surveillance at suppliers during fabrtcation, inspec-tion. resting, and shipment of materials, equipment, and components will be planned.

Witness points will he specified in the procurement documents and surveillance at these points will be performed in accordance with written plans / checklists.

The rece:ving inspect 2on of supplier-furnished mat-erial, equipment ana sarv:ces will be perfcrm'd to procurement documents in accordance with Oual:ty

-sur-ance Procedures, whicF requira thx telinwing:

il' that the material, component, or equipment is proptrly identified and correspeds with the identificatien on the purchase documents' (2) that material, components, equipment and acceptance records are in s;,ec t ed and found to be in accordance with the procurement documents and/or inspection plan / checklist- (3) that inspection records and/or certificates of conformance attesting to the acceptance of material and components a e available, and that; (4) items accepted and released a 2 iden t i fied r

as to their inspection status prior to their removal from the inspection hold area to a controlled storage area, or releasing them for furt her work or use.

8.0 Inspection. Test, and Operating Status The use of inspection and welding stamps and status indicators or other means to indicate inspection and test status, i f used by, or for HNDC, will be in accord-ance with written procedures.

These procedures will also address the bypassing of required inspections, tests, and other cri tical op-erations so that these actions may be controlled.

9.0 Handling, Storage, and Shipping Prior to the release of a transportation package to a customer for first use or f ol lowi nt; a repair or modifi-cation, the cask will be be inspected to assure that QA Manual Addendum HNDC-O-001B

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POLICIES AND PROCEDURES a.

onditions of the NRC package approval and t he U.S.

Department of Transportation shipping requirements are satisfied.

ihis inspection will be performed in accord-ance with an approved inspection plan / checklist and will be documented.

Prior to each shipment of material, the applicable WC Certi ficate of iuthorization with all re fe renc ed drawings and speci fications will L e supplied to the package user-Following loadir.g of the package. it is the responsiblity of the user to verify that the condi-tions detailed in the Certi ficate of Authorization. the routine determinatio.ns described in 10CFR Part 71.54, and the U.S.

Department of Transportation sh:ppi.;

requirements are satisfied prior to release of the s h i pm er. t.

HNDC shipment record forms will be supplied to package users prior to the shipment date.

This form will be completed by the user, with one copy each distributed to the burial site, the user, HNDC, and the driver The shipment form, when completed, documents the package number, shipment origin, shipment destination, a material description, that the results of determinations per 10CFR Part 71.54 are satisfactorily completed, that the i

requirements of the U.S.

Department of Transportation are met, and required survey data in fo rma t ion.

A copy of the shipment form will be maintained by HNDC for a minimum of two (2) years.

Routing of the package will be delineated on a Work Order Form which will be completed for each shipment This form will document the p a c ka p,e truck and trailer serial numbers.

Depa-ture and arrival times will be monitored by the operations department in conjunction with the trucking dispatchers.

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ML19242D040

Contents

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2.2 Orcanization

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4.1 General

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ML19242D040

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2.2 Orcanization

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4.1 General

5.1 General

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