Text

QA Manual
	ML19256F196
Person / Time
Site:	07100024
Issue date:	11/02/1979
From:	; HITTMAN CORP.
To:	;
Shared Package
ML19256F195	List: ML19256F194; ML19256F196;
References
	14614, NUDOCS 7911280395
	Download: ML19256F196 (59)
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D HITTMAN NUCLEAR & DEVELOPMENT CORPORATION 1706 118 e

HITTMAN NUCLEAR & DEVELOPMENT CORPO R ATIO N COLUMBI A, MARYL AND 21045 POLICIES AND PROCEDURES e

L JA _lTY ASSJ7A\\C:

V A\\l A_

Copy #119 Assigned To:

U. S. Nuclear Regulatory Comm, 1706 119 m e s e.,

M PREPARED llNDC-0-001 6

Quality Assurance Manager APPROVED Director, RW Disposal and Support DA.

10/26/79 _ PAGE 1 OF 4

Services 7911280 3Cfd

POLICIES AND PROCEDURES TABLE OF CONTENTS Revision SECTION 1 QUALITY ASSURANCE PROGRAM....................

6 SECTION 2 ORGANIZATION.................................

6 SECTION 3 DESIGN CONTR0L...............................

6 SECTION 4' PROCUREMENT DOCUMENT CONTROL.................

6 SECTION 5 CONTROL OF PURCHASED MATERIAL EQUIPMENT AND SERVICES.................................

6 SECTION 6 IDENTIFICATION AND CONTROL OF MATERIAL, PARTS AND COMPONENTS.........................

6 SECTION 7 HANDLING, STORAGE, AND SHIPPING..............

6 SECTION 8 NONCONFORMANCE MATERIALS, PARTS OF COMP 0NENTS...................................

6 SECTION 9 CORRECTIVE ACTI0N............................

6 SECTION 10 INSPECTION...................................

6 SECTION 11 TEST CONTR0L.................................

6 SECTION 12 INSPECTION, TEST, AND OPERATING STATUS.......

6 SECTION 13 CONTROL OF MEASURING AND TEST EQUIPMENT......

6 SECTION 14 CONTROL OF SPECIAL PROCESSES.................

6 SECTION 15 INSTRUCTIONS, PROCEDURES AND DRAWINGS........

6 SECTION 16 DOCUMENT CONTR0L.............................

6 SECTION 17 QUALITY ASSURANCE RECORDS....................

6 SECTION 18 AUDITS.......................................

6 ADDENDUM A (HNDC-Q-001A) APPLICABLE ONLY TO PROJECT M623.

DISTRIBUTION SEPARATELY CONTROLLED ADDENDUM B (HNDC-Q-001B) APPLICABLE TO TRANSPORTATION CASKS LICENSED UNDER 10CFR PART 71 1

ADDENDUM C (HNDC-0-001C) APPLICABLE ONLY TO CECO PROJECTS.

DISTRIBUTION SEPARATELY CONTROLLED

-l706 120 Quality Assurance Manual HNDC-0-001 6

, PAG E __2.OF _4 TlTLE NUMBER REV.

POLICIES AND PROCEDURES REVISION

SUMMARY

SECTION 1 - Pages Renumbered to Address New Danual Format and Revised as Highlighted

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SECTION 2 - Pages Renumbered to. Address New Format SECTION 3 - Pages Renumbered to Address New Format SECTION 4 - Pages Renumbered to Address New Format and Revised as Highlighted SECTION 5 - Pages Renumbered to Address New Format SECTION 6 - Pages Renumbered to Address New Format SECTION 7 - Pages Renumbered to Address New Format SECTION 8 - Pages Renumbered to Address New Format SECTION 9 - Pages Renumbered to Address New Format SECTION 10 - Pages Renumbered to Address New Format SECTION_11 - Pages Renumbered to Address New Format SECTION 12 - Pages Renumbered to Address New Format SECTION 13 - Pages Renumbered to Address New Formac SECTION 14 - Pages Renumbered to Address New Format SECTION 15 - Pages Renumbered to Address New Format SECTION 16 - Pages Renumbered to Address New Format SECTION 17 - Pages Renumbered to Address New Format SECTION 18 - Pages Renumbered to Address New Format and Revised as Highlighted ADDENDUM HNDC-Q-001B - Revised as Highlighted 1706 121 Quality Assurance Manual HNDC-Q-001 6

PAGE d OF1 TITLE NUMBER R E V.

POLICIES AND PROCEDURES HITTMAN NUCLEAR & DEVELOPMENT CORPORATION QUALITY ASSURANCE POLICY s

It is the' policy of Hittman Nuclear & Development Corporation (HNDC) to supply products.that satisfy the quality requirements of its customers and comply with all regulatory criteria within the scope of its business ventures.

The HNDC Quality Assurance Manual is the approved medium designating the guidelines to accomplish the objective of this policy.

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

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Barry Koh Vice President and General Manager 1706 122 Ouality Assurance Manual HNDC-O-001 6

PAGE b OF1 TITLE NUMBER R E V.

POLICIES AND PROCEDURES SECTION 1 QUALITY ASSURANCE PROGRAM

1.1 General

The ilNDC Quality Assurance Program assures that the provisions of applicable Codes, customers specifications, Federal Regulations, and IINDC directives are fully implemented.

The Director of Radwaste Disposal and Support Services is responsible for its establishment, implementation, and execution.

The vehicle for trans-mittal of t his program to all levels of management is the IINDC Quality Assurance Manual.

Although the work of establishing or executing all or part of t his Quality Assurance Program may be delegated to others, IINDC shall retain responsibility for the 6

program.

1.2 Applicability

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

The IINDC QA Manager is responsible for ensuring that the described QA Program is fully implemented by the llNDC organization, its vendors and subcontractors.

1.3 QA Program:

The program provides wri t ten policies, procedures, and where necessary, instructions covering the following quality aspects.

1.

Organization 2.

l'ersonnel Training 3.

Design Control 4.

Procurement Control

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5.

Receiving Control 6.

Mat crial Storage, llandling, and Maintenance 7.

Control of Special Processes 8.

Inspection, Test, and Assembly Status 9.

Nonconforming Material Control 10.

CorrecLIve Action 11.

Packaging & Shipping 1706 123 Ouality Assurance Manual llNDC-0-001 (Sect. 1) 6 1

PAGE _ OFd TlTLE NUMBER REV.

POLICIES AND PROCEDURES 12.

Document Control 13.

Cont rol of ficasuring and Test Equipment 14.

Audits The IINDC QA Manual (IINDC-Q-001) wi11 be the controlling procedure for all applicable contracts and will set forth the minimum criteria applicable to delivering a quality product.

Vendors and subcontractors may be delegat ed speci fic responsibility for quality assurance by HNDC as an extension of the IINDC QA Program.

Dele-gated program responsibility shall conforr. to this standard and be approved by IINDC.

1.4 Quality Assurance Manual:

This manual and referenced appendices set forth the policy which add ess the requirements of 10CFR Part 71 Appendix E.

It also addresses the criteria given in 10CFR Part 50 Appendix B, N45.2 and the NRC position paper 11-1 & 11-3.

Iloweve r, 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 IINDC.

The re fo re,

the llNDC QA policy and program implementation is based on an ext ract ion from these documents and is designed to comply with their intent.

1.5 Quality Assurance Procedures:

Based on the policies in the llNDC QA Manua1, detailed QA procedures are developed to implement and control the program.

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

The QA 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 subcontractors will be evaluated by IINDC to ensure that their QA Programs comply with the require-ments of IINDC di rect ives to the extent required on llNDC's contract spec i fica t ions.

Vendors and subcon-tractors not meet.ing these requirements may elect to conform t o the llNDC program as applicable to the items being furnished to HNDC.

1706 124 Ouality Assurance Manual HNDC-O-001 ( S n c t- - 13 6

PAGE _ 2 OF_6_

TITLE NUMBER R E V.

POLICIES AND PROCEDURES 1.6 Periodic Review of The Quality Assurance Program:

The preparation and continued maintenance of the Quality Assurance Manual is the responsibility of the q2ality Assurance Manager.

All manuals will be controlled caless specifically designated by the QA Manager.

The applicable revision of each manual section and general addendum will be as denoted on the latest revision of the table of contents.

The distribution of addendum 6

applicable only to a specific job number will be con-trolled separately and the applicable revision will not be included on the table of contents.

The status and adequacy of the program and its manuals will be regularly reviewed by the Quality Assurance Manager.

This is supplemented by periodic audits conducted to assure implementation of the program requirements, and to revise the program to properly reflect changing codes, standards, regulatory and operational requirements.

1.7 Qualification Requirements For QA Supervision:

QA Manager:

A.

Education B.S. Engineering or B.S. Management B.

Specialized, Technical Knowledge 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 techniauos such as welding, painting, testing and measuraaent practices and be familiar with applicable coues, standards, and federal regulations.

C.

Kind and 1.ength 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 years of which is related to a position in a supervisory capacity is also desirable.

i706 125 Ouality Assurance Manual HNDC O-001 (Sect. 1) 6 3

6 TITLE NUMBER REV.

POLICIES AND PROCEDURES QA Engineer:

A.

Education:

A B.S. degree in an Engineering discipline.

B.

Specialized, Technical Knowledge or Skills:

An individual with a B.S.

in Engineering; in addition, experience in fields of Quality Control /

Quality Assurance methods and basic knowledge for Quality Assurance requirements 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.

1.8 Personnel Training TRAINING PLAN FOR OPERATIONAL QUALITY ASSURANCE PERSONNEL PURPOSE:

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

IL shall be the int ent of t his plan to ultimately qualify each individual to a level whereb~y his performance will insure the policies of IINDC will be en-fo rc ed.

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 of the new employee, the manager of Quali t y Assurance may delete selected portions of this plan to suit the indivi-dual.

6 RESPONSIB1LITY:

The Manager of Qua1 i t y Assurance shalI be responsRli for implementing this plan.

1706 126 Quality Assurance Manual HNDC-0-001 (s o c t-1T r'

4 6

TITLE NUMBER REV.

POLICIES AND PROCEDURES PROCEDURE:

The Quality Assurance t raining program is divided into four distinct sections.

Their order may be altered to suit the circumstances.

(Sections 3 and 4 will 6

not apply to clerical personnel.)

1.

Company Indoctrination - in which the employee is briefed by his immediate supervisor on company policies using t he guidance of " Individual Orientation Proced-ure," a copy of which is placed in the employee's training record.

Additionally, administrative matters such as time sheet preparation, expense report pre-parat. ion and Xerox machine operation are covered.

2.

Quality Assurance Introduction - in which the employee is introduced to the overall purpose and philosophy of the quali ty assurance ef fort, and his individual job function.

This is accomplished by reading references in section four, consulting the knowledgeable indi-vidual as to the application of HNDC systems and com-pleting 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 employee gains a basic knowledge of nuclear plant design and theory.

The extent of this t raining will be determined on a case basis by the Manager of Quality Assurance.

2.2 Organization

The IINDC Ouality Assurance, Support Services, and Engi-neering Departments contribute to the QA 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 the authority, organizational f reedom and independence of personnel performing Quality Assurance functions to identi fy cluali ty problems, to initiate, recommend or provide solutions and to veri fy implementation of solutions.

2.3.1 D_irector of Radwaste Disposal and Support Services The direct responsibility for the conduct and implement ation 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 llNDC

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products meet the cri t erion of cust omer speeificaLions, llNDC direetives and appiicab1e codes and regulations.

1706 129 Quality Assurance Manual llNDC-0-001 (Sect. Q 6

PAG E._1_ OF_g_

TIT L E NUMBER REV.

POLICIES A$D PROCEDURES 2.3.2 Quality Assurance flanager The specific responsibility to coordinate and implement the Quality Assurance Program is assigned t.o the Quality Assurance Manager.

Ile reports to the Director of Radwaste Dis-posal and Support Services and supervises the Quality Assurance Organization.

He also has direct access to the General Manager to resolve problems whereby the Director of Radwaste Disposal and Support Services and the Quality Assurance Manager are not in agreement.

This gives him a degree of f reedom required to insure luality relat ed decisions are not controlled by administ rat ive aut hori t y.

Under his direction, quality matters will be segregated between the client, IINDC and its vendors and subcontractors for correct. ion in a responsible and timely manner.

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

Authority _ and Responsibilith 2.4 The Quality Assurance Department's authority comes by way of t he c1ients imposed eriteria, Federa1 Regulations and IINDC's commitment to a Quality Assurance Program which will enhance t he quali ty of our product..

Persons performing quality assurance functions shall have su f fic i en t authority and organizational freedom to:

(1)

I(ient i fy quality problems (2)

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

Veri fy implementation of solut ions (4)

Cont rol further processing, delivery or instal-lation of a nonconforming item, deficiency, or unsat isfactory condition unt.il proper disposition-ing has occurred.

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1706 130 Ouality Assurance Manual HNDC-0-001 (Sect. 2) 6 PAGE _ _2. O F_9 TiTtE NUMBER R E Y.

POLICIES AND PROCEDURES 2.5 Qualification of Personnel The Quality Assurance personnel shall possess the necessary skills and experience to perform the inspec-tion, test or audi ts on which they are assigned.

All Quality Assurance personnel shall be certified in accordance with the training program in Section 1 of this manual.

Documentation supporting this training will be developed and maintained.

2.6 Position Responsibilities (see Figures 1.1, 1.2, and 1.3)

General Manager Responsibilities include the development and imple-mentat ion of corporat e policy, including the estab-lishment and initiation of the IINDC Quality Assurance Program.

Director of Radwaste Disposal and Support Services Responsibilities include the establishment and im-plementat ion of functions within the sections reporting to him.

These include establishment, implementation, and approval of the lINDC Quality Assurance Progra,a.

Director of Marketing and Projects Responsibilit.ies include t he presentation of IINDC production and service applications to utilitles and. architectural / engineering f i rm s,- proposal preparation; and input into the development of new products and services.

Also included is the establishment and implementat ion of functions within the engineering and field project s groups.

Vice-President - Engineering Responsibilities include the establishment and imple-mentation of functions within the engineering group and the oversight. of internal research and development.

Material _ Con _ trol Supervisor Responsbilitles i ne I ude pu rchas i ng, expediting, internaI ma l e r i.i l con t rol, and t he deve lopmen t and implementation of material cont rol procedures and inst ruct ions.

1706 131 Quality Assurance Manual IINDC-0-001 (Sect. 2) 6 PAGE _3. O F __9_

TITLE NUMBER R E V.

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

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Contract Administrator As the administrative liaison with utilities and archi-tectural/ engineering firms, his responsibilities include the distribution of purchase orders, referenced speci fica t ions, and bid requests to appropriate personnel for their review.

IIcalth Physics Of ficer Responsibilities include developing and implementing IIcal th Physics procedures, monitoring radiation ex-posures of personnel, and oversight of the handling of radioactive material.

Quality Assurance Manager Responsibilities include the development and implemen-t at ion o f t he ilNDC Quali t y Assurance Program; veri fica-tion of program implementation by audit: vendor evalua-tions; spec i fication, procedure and purchase order review; material inspections; the development and cont rol o f Quality Assurance procedures, specifica-tions, and instructions; and all other Quality 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 transport ation cask shipments from the United States Eastern region; scheduling of cask maintenance and the procurement of cask spare and replacement pa rt s and maintenance services; the transmission of cask cert i fi-

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cations and re ferenced document s to package users; and the development and implementation of cask operating and maintenance procedures and instructions.

I706 n?

Ouality Assurance Manual llNDC-0-001 (Sect. 2) 6 4

9 TITLE NUMBER REV.

POLICIES AND PROCEDURES Flaintenance Supervisor Responsibilities include direct oversight of cask maintenance and the procurement of spare and replace-ment parts.

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Fla nage r, Systems and Equipment Design Responsibilities include t he oversight of design drafting personnel; the initiation and review of drawings, specifications, calculations, and the test procedures; the preparation of Safety Analysis Reports and Topical Reports; the review and disposition of noncon fo rmances ; the review of special test results; the development and implementat ion of Engineering pro-cedures and instructions.

Engineeri_ng Project Group Flanager Responsibilities include management of Radwaste Solidification System Projects.

Field Proj ects flanager Responsibilities include the oversight of Field Rad-waste Packaging Services.

1706 133 Ouality Assurance Manual llNDC-0-001 '(Sect. 2) 6 5

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POLICIES AND PROCEDURES SECTioN 3 DESIGN CONTROL

3.1 General

The llNDC QualiLy Assurance Program provides assurance that applicable design criteria are correctly translated into spec i fica t ions, dra ings, procedures, and instruc-tions.

The essential elements required in these design document s affecting the quality and safety of IINDC systems are implemented in accordance with this section.

3.2 Responsibility

HNDC has t he ultimate responsibility for controlling design activities affecting its product 1inc.

The lINDC Engineering procedures and instructions for draf ting /

design and design control activities will detail this responsibi1ity.

3.3 Design Criteria 3.3.1 Design criteria related to the safety and quali Ly aspects of IINDC's products as re-flected in the applicable code, customer contract documents, and Federal Regulations are essent ial elements of IINDC design cont rol.

3.3.2 They are incorporated into the design by speci fications and drawings.

Review of the speci fications and drawings by ot her than the original designer and final review by customer's technical sta f f (when required) provide the assurance that the proper design criteria have been incorporated.

3.3.3 Variations in criteria of project controlled drawings and specifications as dictated by the customer will be identi fied and cont rolled by the Project Manager in accordance with Engineering procedures governing design and document control.

3.4 Drawings and Specification Controls 3.4.1 Control of drawings and speci ficat ions, and revisions to, or deviations from, drawings and specifications is the responsibility of 1706 138 Ouality Assurance Manual IINDC-0-001 (Sect. 3) 6 1

3 TITLE NUMBER REV.

POLICIES AND PROCEDURES t he Vice President of Engineering and is delineated in System Engineering Procedures.

3.5 Engineering Approval 3.5.1 Engineering approval is required for all

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changes to, or deviations from, drawings and specifications.

The Vi.ce President - Engi-neering or his delegated representative, exercises this approval by review of drawings and specifications.

3.5.2 Approval required in oroject controlled drawings and speci fications, as dictated by the customer, will be made only by the Project Manager in accordance with Engineering proce-dures governing design and document control.

3.6 Selection and Applicability of Materials 3.6.1 selection and applicability of materials, parts, equipment, and processes related to t he safety and quality of IINDC product lines shall be strictly controlled by Engineering.

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

3.6.2 Where there is a special technical need or material application that is not within the capabili ty o f the HNDC organir.ation, 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 will be performed by use of hand calculations independently checked by another engineer.

3.7.3 Test programs for the veri ficat ion of design integrity may be required and wilI be approved by the Engineering Supervisor a f t er appro-priate design review of the subject.

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1706 139 Quality Assurance Manual HNDC-0-001 (Sect. 31 6

2 3

TITLE NUMBER REV.

POLICIES AND PROCEDURES 3.7.4 The verification of design checking process is conducted by persons other than the orig-inal designer.

Each document veri fied in this manner will have the checker's signature or initial in addition to the designer's.

3.8 Design Changes 3.8.1 Design changes are controlled in the same manner as the original design, and shal1 be made in accordance with the engineering design and engineering document control procedures.

3.8.2 The llNDC Engineering Change Notice and Engi-neering Change Request System will be used to control and document all design changes.

3.8.3 Reference copies of drawings will be maintained in the Master Design File.

3.9 Design Control Implementation 3.9.1 The provisions of this section are detailed in subsequent sect ions speci fically dealing with design control procedures.

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

3.10 Veri fi ca t_ ion o f Compliance 3.10.]

The QA Depart ment wili verify comptiance with t his di rective and the e f fect.iveness of establishe'd procedures by means of periodic audit.

1706 140 Quality Assurance Manual HNDC-Q-001 (Sect. 3) 6 3

3 TITLE NUMBER REV.

POLICIES AND PROCEDURES SECTION 4 PROCUREllENT DOCUf1ENT CONTROL

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4.1 General

The liNDC procurement documents include criLeria and requirements pertinent to supply a satisfactory, depend-able, trouble free product.

The review prior to the placement of the purchase order, ensures that the necessary code compliance, design bases, client spec i fi-cation requirements, and regulatory requirements are included.

4.2 Procurement Documents:

4.2.1 A Purchase Reytisition (PR) will be developed from the client's speci fication and/or appli-cable llNDC design documents.

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

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

The Mat erial C,ntrol Surervisor awards a cont ract,

purchasing tne item from a supplier on the Approved Vendors List.

4.3 Procurement Document Review 4.3.1 These documents are reviewed by the IINDC Quali ty Assurance Manager t o confirm the accuracy and adequacy of the quality references and requirements.

The purpose of i he review is to determine that: (1) quality requirements are correctly stated, inspectable and control-lable, (2) toere are adequate acceptance and rejection criteria, (3) the documents have been prepared, reviewed and approved in accordance with qua1ity assurance procedures, and (4) that changes and revisions to procure-ment documents af fec t ing quali ty assurance 6

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are reviewed and approved at the same scope and depth commensurat e wi t h t he original document.

" Purchase Requisitions" are re-viewed for vendor select ion and that the documents required for cert i fication of the material to be used are included as a documen-tation requirement.

1706 141 Quality Assurance Manual HNDC-0-001 (Sect. 4) 6 PAGE __1_ O F __2_

TITLE NUMBER REV.

POLICIES AND PROCEDURES 4.3.2 Procurement docuinents will be reviewed and approved by the Director of Market ing and 6

Projects.

4.3.3 The llNDC Pro. ject Manager wilI be responsible for collecting and resolving "in-house" comments on llNDC documents as well as vendor purchase documents in accordance with !!NDC procurement and engineering document. control procedures.

4.4 Vendors and Subcontractors 4.4.1 Purchase documents for sa fety and qualit y re1ated items wilI require IINDC vendors and subcont rac tors to provide QA programs and procedures to the extent. necessary to comply wit h requirement s of IINDC's purchase order documents and with any Federal llegulation.

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

f 1706 142 Quality Assurance Manual llNDC-Q-001 (Sect. 4) 6 2

2 TITLE NUMBE R REV.

POLICIES AND PROCEDURES SECTION 5 CONTROL OF PURCilASED MATERIAL, EQUIPMENT AND SERVICES

5.1 General

Measures wit hin t.he llNDC Quality Assurance Program assure that purchase material, equipment, and services shall conform to the procurement documents.

Such measures are taken before and af ter issuance of t he procurement documents.

5.2 Procurement Documents:

5.2.1 Procurement documents consist of speci fica-tions, purchase orders, drawings, procedures, and, if applicable, an Engineering and Quality Verification Documentation Requirements (EQVDR) Form for the purchase of an item.

The EQVDR specifies supplier documentation submittals.

5.3 IINDC Purchase Order Requirements 5.3.1 The purchase order requi rement s (e.g. Painting, Cleaning, Packaging, Welding, etc.) may be imposed on IINDC subvendors by one of the foilowing met. hods :

A.

Subvendor 131anket Acceptance of t he llequ i remen t.

In the event that t he subvendor agrees to supply equipment in accordance with the applicable llNDC technical standard and/or the stated requi rement s in an RFQ, then a copy of t he procedure is referenced in t.he vendor /IINDC purchase documents'.

II.

Subvendor Submittal of Equal Proce_ dure in the event t h.i t.

the vendor has an established shop procedure which fully satisfies the lINDC requirements, then llNDC will review his procedure.

If it meets the llNDC requirements, the vendor procedure shall be implemented in lieu of the llNDC standard procedure.

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POLICIES AND PROCEDURES C.

Quali ty Veri fication at IINDC in the event a vendor cannot conduct the required quality cont rol tes, ting or examination at his facility, then llNDC shalI have t he option of either conduc-ting the required tests, examinations, etc. at ilNDC f a c i l. i t i e s, or to conduct these tests at another ilNDC designated subvendor shop.

D.

Standard Parts In the event the subvendor standard product meets all requirements, then HNDC's Engineering shall review the documents describing this product.

Upon approval, the liNDC purchase agreement with the vendor shall only include the description of the standard product.

5.4 Source Evaluation Conduct ing of source evaluations to determine objective evidence of source quality, contractor performance and the delivery of a Quality Product. is the responsibility of the 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 a measure of the vendor acceptabili ty to the "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 approval of his services or equipment.

5.4.3 Quality on delivery will be determined by physical inspection at ilNDC or by a receipt.

inspection report made on de1ivery at point of dest inat ion.

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POLICIES AND PROCEDURES 5.5 Periodic Assessment of Vendors and subcontractors 6.5.1 Those vendors or subcont ractors quali fied for inclusion on the " Approved Vendors List" will be requalified periodically.

The QA flanager will det ermine when requali fi-cat ion of a vendor or subcontractor is required.

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

5.6 Manufacturer's Standard Equipment When a purchased item is a standard, non-safety related, off-the-shelf product, the vendor may be quali fied through t he use of a Quali ty Rat ing System.

This system wi11 receive input from the Qua1ity Assurance Vendor Survey Form, supplier and internal non-conformance reports, and receipt inspection reports.

A receipt inspection will be performed on all items.

The Quality Rating System will be detailed within llNDC Quality Assurance Procedures.

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POLICIES AND PROCEDURES SECTION 6 IDENTIFICATION AND CONTROL. OF MATERIAL., PARTS, AND COMPONENTS 6.1 Genera 1:

The requirements for ident i ficalion and cont rol of material, parts, and components will be implement ed lay llNDC, it s vendors and subcont ractors.

The methods and systems used for identi fication and control will be developed from client speci fications and Federal Regul.1-tions.

The vendor /subcont ractor may be audited during the fabricat ion of the product by llNDC to ensure com-pliance with his established program.

6.2 Identi ficat ion of Materials:

6.2.1 Materials, parts, and components including partial assemblies shall be identified and cont rolled as speci fled in purchase docu-ments.

IINDC shall define this requirement and require vendors and their subcontractors to ident i fy t heir equipment and material in a similar manner.

6.2.2 The llNDC Project Manager and QA Manager shall assure, during t hei r review of purchase docu-ments, that requi rement s for t he identifica-tion and control of materials, if applicable, are specified.

6.2.3 The correct ident i fication of mat erials, 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 Traceabi1ity

6.3.1 The iden t.i fica tion o f mat erial s and pa rt s important to the function of safet y-relat ed systems and components will be maintained so as to be traceable to the appropriate documen-tation, such as drawings, spec i ficat ions,

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POLICIES AND PROCEDURES purchase orders, manufacturing and inspection documents, deviation reports, and physical and chemical mill test reports.

6.3.2 The locat ion and method of ident i fication will be carefully determined so that the fit, function, and quality of t he item being identified will not be,a f fect ed.

6.4 Identification Through Fabrication and Installation:

6.4.1 Ident i fication of ASME Code mat erial during fabrication, erection, inst allat ion, and ultimate use will be as specified as ASME Code.

6.4.2 Noncode material is identi fied and cont rolled in accordance wi t h IINDC's purchase document requi rements, or t.he vendor /subcont rac tors QA procedures used for non-ASME Code items.

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POLICIES AND PROCEDURES SECTION 7 IIANDLING, STOllAGI:, MAINTENANCE AND SillPPING 7 '.1 General:

These measures may be delegat ed t.o a vendor or subcon-tractor fabricating, manu f ac tu ri ng, handling, or ship-ping IINDC equipment.

Instructions or procedures dev-eloped by the vendor or his subcontractor for handling, storage and shipping will be subject to review and andit by llNDC.

In-house handling, storage, maintenance and shipping wil1 be condueted in accordance with IINDC contro11ed procedures.

7.2 Requirements

7.2.]

The proper requirements for packaging, preser-vation, field storage, handling in storage, testing, cleaning, and monitoring of materials, components, and equipment when requi red are ident i fied in llNDC speci fications, detailed procedures, purchase orders, and drawings.

7.2.2 These requirement s are est ablished by llNDC in accordance with speci fication or regulat ory requirements.

The llNDC cognizant' engineer establishes vendor procedure requ i rem: nt s during his review of t hese document s.

The vendor may implement the llNDC procedures or submit his own for IINDC approva1.

7.3 Minimum Standards Requirements:

7.3.1 Minimum standard requirements for packaging, storage, maintenance, shipping, and handling are speci fied in llNDC speci fications, purchase orders, procedures and drawings.

These instructions are prepared and reviewed in the same manner as in Section 7.2.

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POLICIES AND PROCEDURES 7.4

" Reject" and "llold" Status of Equipment:

7.4.1 Equipment in a " Reject" or "llold" status shall be handled, stored, or in the case of manufactured items shipped on a Risk Ilasis as described in Section 8 to llNDC or another subvendor for disposition shall be in accord-ance with speci fication requi rements.

A

" Reject" or "llold" status does not alter any responsibility in the handling, storing, or shipping of the equipment.

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I-

POLICIES AND PROCEDURES SECTION 8 NONCONFORMING f!ATERIALS, PARTS OR COf1PONENTS

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8.1 General

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

8.2 Control of Nonconforming Items:

8.2.1 Noncon fo rmi ng items shall be identified and rigidly controlled for all safety and quality related items.

Items not con forming t o specifications and drawings are tagged " Reject" or "liold" with controlled tags issued by the QA Manager.

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

8.2.2 The acceptabili.ty of rework or repair of materials, parts, components, and systems is verified 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.

8.3 Supplier Nonconformances:

8.3.1 Deviat ions or noncon formance t.o llNDC speci fi-cations, purchase orders, drawings, and procedures shall be report ed by llNDC's contrac-t ors or subcontractors to llNDC, via a Non-conformance and Deviation Report (N&D).

8.3.2 For the nonconforming item, the vendor or subcontractor sha11 describe the noncon-formance precisely, and recommend corrective action including an alternate solution.

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POLICIES AND PROCEDURES 8.3.3 A vendor or subcontractor may elect to use his own N&D form, provided the in forma t ion thereon is substantially the same as that on the llNDC form.

8.3.4 Where there is a noncon formance, the vendor or subcontractor shall attach a " Reject" or "llold" form to the item and ensure it is not removed until disposition has been made.

8.3.5 A " Reject" or "llold" tag is used by llNDC when the it.cm is nonconforming and needs corrective action.

A " Reject" or "llold" t ag is also used to indicate that additional i n forma t ion or documentation is needed to fulfill the purchase document requirements.

An N&D submission is not necessary for this purpose.

The "llold" tag placement, removal and the resulting corrective action will be documented on the QA Receipt Inspection Form.

8.3.6 N&D reports shall be forwarded to a cognizant ilNDC Engineer for disposition.

8.3.7 Disposition may take the form of Acceptance; Scrap; Repair; or Modi fy.

8.3.8 Upon completion of the disposition and the N&D form approved by the cognizant Engineer, the QA Manager and the Project Engineer, the form will be forwarded to the Material Control Department.

Copies are maintained in the Project Master File, QA File and Purchasing Master File.

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8.3.9 When corrective action is completed, an item will be considered ready for inspection.

IINDC will reserve the right to inspect the item for compl iance wi t h t he N&D report disposition.

The QA Manager shalI veriIy that the action has been properly completed

. will sign of f the N&D form.

I f t he action is not correct, anot her N&D report wilI be issued eiting the additional "Noncon-formance or Deviation".

8.3.10 The llNDC inspector will forward copies of t he complet ed N&D form to t he llNDC QA Manager for record retention.

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POLICIES AND PROCEDURES 8.4 Internal Nonconformances llNDC nonconformances to specifications, purchase orders, drawings, procedures, or instructions will be documented on a corrective action notice form.

Issuance and

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completion of this form will be monitored and con-trol 1ed by the Qua1ity Assurance Manager in accordance with Quality Assurance I)roceciures.

8.5 Risk Released Items:

8.5.1 In the event that the project manager is requested to ship an item by the client without proper documentation or with a qua1ity related deficiency, he shall initiate a Risk Release Basis form for approval by the Quality Assurance Manager and Director of Marketing and Projects.

8.5.2 The Project Manager shall sign the release and submit same to the Quality Assurance Manager for his review and approvals as indicated in Section 8.4.1.

8.6 Risk Release Enforcement 8.6.1 In t he event of an item being released on a risk basis, the Quali t y Assurance Mwager or his designated alternate shall assure that the condition on the Risk Release is enforced.

When all the conditions are resolved, the Risk Release wilI be cleared and a copy forwarded to Material Cont rol Supervisor, Project Manager and Contracts Administrator.

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POLICIES AND PROCEDURES SECTION 9 CORRECTIVE ACTION

9.1 General

Measures within the !!NDC Quality Assurance Program assure that conditions adverse to quality are promptly ideatified and corrected in a timely manner.

The responsibility for implement ing corrective action systems rests with the QA Manager.

9.2 Identification and Correction:

The Quality Assurance Manager is iesponsible for ensur-ing that conditions adverse to a quality product such as deviations, nonconformances, de fec t ive items, risk release items etc., are identified and appropriate corrective action is taken.

9.2.1 The principal source of quality defects i den t i fica tion is the Nonconformance and Deviation Report, the Receipt Inspection Form and the corrective action notice.

The QA program shall ensure appropriate distribution for all documents reportir.g quality problems and shal1 ident i fy t he act ion necessary for correct documentation.

9.2.2 The QA Manager will review all noncon formance report s for accuracy, completeness, and assignment for corrective action.

9.2.3 Upon completion of the evaluation and dispo-sition of N&D Report s, 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 shal1 ensure that N&D Reports receive proper evaluation and disposition within a reasonable time.

Those disposit. ions not resolved in a timely fashion will be brought to the at t ent ion of t he Di rector of Engineering and Proj ets.

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P.OLICIES AbjD PROCEDURES 9.2.5 Follow-up reviews will be conducted t o veri fy proper innpl einen t a t ion o f correc t ive actions and to close-out the Noncon fo rtna nce and Deviated Report.s, Correc t ive Action Report s,

and Receipt inspection Forms.

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9.2.6 In the event of an item being released on a risk basis, the Quality Assuranco Manager or his designated alternate shall assure that the condition on the Risk Release is enforced.

When all the conditions are resolved, the Risk Release will be cleared and copies forwarded t o Material Cont rol, t he cognizant Project Manager, and Contracts Administration.

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POLICIES AND PROCEDURES SECTION 10 INSPECTION 10.1 General-The inspection function is performed by llNDC, vendors, and subcont ractors and will be performed in accordance with an inspection plan.

Vendors and subcontractors will be required to establish and follow an inspection plan as required by regulatory and/or elient require-ments and by the complexity of the material, part, or component and its relation to safety.

10.2 Inspection Areas:

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

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

10. 3 "lloid Poi n t s":

10.3.1 Inspection "lloid Points" may be designated on the purchasing documents EQVDR or in the cont.rol1 ing procedure in accordance with the applicable inspection plan.

Work will not be continued until a QA representative witnesses or releases the particular "llold Point."

10.3.2 A list of "llold Points" will be inserted by the cognizant Proj ec t Flanage r i n the speci-fication, controlling procedures, and/or purchasing documents.

These will be reviewed by the QA Flanager.

10.4 Incle[>endence o f QA.and P r@lu_c t ion _ Pe rsonne l.

10.4.1 IINI)C ' s policy is to provide f or t he separa-t ion of t he interests of inspection and produc t. ion personnel in al1 aspect.s of the QA Program.

Inspection personnel will be independent from the individuals performing the activily being inspected.

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POLICIES AND PROCEDURES 10.o.2 Vendor supplied items shall be inspect. ion accepted by the vendor's inspectors who are not assigned to a production department or other group that might influence the decisions of the inspector.

10.4.3 HNDC will assess the relationship of inspection to production or operat, ions activities by means o f audit.s/ inspect ions.

10.5 "STOP WORK" Order:

10.5.1 The QA Manager and/or his delegated repre-sentative may institute a "Stop Work" order, based on an unsatis fac tory report, test witnessing, audit, or routine surveillance.

It shall be the responsibility of the QA Manager to provide the Director of Radwaste Disposal and Support Services with the details pertinent to the "Stop Work" action for his review and approval.

This must be accomplished as soon as pract ical af t er t he initial "Stop Work" order is initiated.

Where time allows, this review and approval shall be accomplished prior to the issuance of a "Stop Work" order.

10.5.2 Restart of work will depend on the satis-fact ory correc t ion of the de ficiency and documented by complet. ion of t he Noncon formance and Deviation (N&D) report, reporting the de fi c i ency.

10.6 Evaluations:

10.6.1 The N&D report will be distributed to the appropriate personne1.

10.6.2 The QA Manager wi1i review dist ribut ion 1ists to veri fy that the concerned personnel are receiving the N&D report.

10.6.3 Completed N&D report s wi il be reviewed by the QA Manager for ecmpi iance.

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POLICIES AND PROCEDURES 10.7 Inspec t ion o f t!odi fications, Repairs, and Replacements flodi fi ca t ions, repairs, and replacements will be inspected in accordance with the original design and inspection requirements or acceptable alternatives.

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l'.8 Quali fications:

Inspect ors will be quali fied in accordance with the llNDC Quality Assurance Training Program.

This program will incorporate the requirements of applicable regula-tions, codes, and standards.

Documents supporting this training will be filed and kept current.

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POLICIES AND PROCEDURES SECTiON 11 TEST CONTROL 11.1 General:

Testing of IINDC supplied equipment is conducted in vendor or subcontractor shops or llNDC facilities in accordance with prescribed test procedures, or speci fi-cations.

Tests may be witnessed or audi ted by liNDC representatives and, where necessary, the results evaluated by a cognizant IINDC engineer.

11.2 Fabrication Tests:

11.3.1 In-process and final tests will be performed as requi red by speci fications, drawings, and applicable codes.

These 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 applicable inspection plan.

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

11.3.3 IINDC will 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 cognizant engineer for evaluation and disposition.

11.4 Preoperational Tests (solidi fication system only):

11.4.I l>reopera t ional tests are typical 1y conducted by the uitimate user.

ilNDC assists in ihe perf ormance of t hese iests as required.

11.5 gperational Tests (solidification system onlyJ:

11.5.1 Operational tests are typically conducted by the ultimat.e user.

IINDC ass.ists in the per-formance of these test.s as required.

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POLICIES AND PROCEDURES 11.6 Test Cont rol :

11.6.1 Prior to IINDC testing, a procedure of suf fi-cient detail will be developed by a cognizant IINDC engineer, included in this procedure

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will be acceptance and rejection criteria or the requirement that the t.est result.s be reviewed and approved by the engineer prior to acceptance.

11.6.2 Prior to testing by a vendor, the test pro-cedure, as required by the procurement docu-ments, will be submi tted for review by llNDC engi nee ri ng.

Review of this procedure will include approval of acceptan'ce/ rejection criteria or submittal of test results to llNDC engineering for approval.

11.6.3 Modifications, repairs, and replacements will be tested in accordance with the original design and testing requirements or acceptable a1ternatives.

11.7 Special Testing:

11.7.1 Special t est ing of component s or equipment and the type of t esting to be conducted will be as defined, on a case basis, in specifi-cations.

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

11.8 Engineering Evaluation:

11.8.1 In special cases where an actual test cannot be performed, i.e.,

a dest ruc t.ive test, engi-neering will determine through mathematical evaluation the adequacy of the design para-meters.

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POLICIES AND PROCEDURES SECTION 12 INSPECTION, TEST, AND OPERATING STATUS

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12.1 General:

IINDC will maintain a system to indicate the status of inspection and/or test requi rements of individual components and equipment within the scope of the QA p rog ram.

12.2 Status of Systems:

12.2.1 St atus of inspect ion or tests of individual components and equipment wilI be maintained and kept current.

12.2.2 An identification system may use a Lagging or color coding process.

In the case of ASME Section III work, the " traveler" system will identify each stage the item has passed and the inspection perfcrmed, 12.2.3 Records of inspections performed (e.g.,

receipt inspection, shop tests, etc.) will be fi1ed by the QA Department.

12.2.4 Records of vendors or subcont ract ors tests and inspections will be maintained by the vendor or subcont ractor unt il the equipment is shipped.

Where radiography is required or specified, radiographs will be maintained by the vendor or subcont ractor pending customer disposition in accordance with applicable code requirements.

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POLICIES AND PROCEDURES SECTION 13 CONTROI,OF MEASURING AND TEST EQUIPMENT 13.1 General:

Measuring and test equipment are controlled items.

Each will be identi fied by a serial number and sticker indicating the calibration status and will be issued only by the Quality Assurance Manager.

13.2 Calibration:

The calibration of measuring and test equipment will be performed annually or more frequently, if recommended by the equipment manufacturer.

The calibration shall be performed with standards traceable to the National Bureau o f St andards.

No item will be issued without a current calibration sticker.

The calibration period of a measuring or test device may be allowed to expire if it is not expected to be used for an ext ended period of time.

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

13.3 Maintenance:

If cont rolled equipment is damaged, dropped, or i f the user becomes suspicious of damage, use of t he item will stop immediately and the calibration will be veri fied.

13.4 Documentation:

Calibration test data, traceable to the equipment by serial number, will be maintained and filed.

A log will be maintained to document. usage of each controlled item sc,that in the event it is found to be out of calibration, usage may be traced to inspected items.

These items will tagged irmnediately with a hold t ag and reinspected with calibrated equipment.

A corrective action notice (see Section 8) will be issued immediately to llNDC engineering, which will. evaluate the condition of the suspect items.

If it is determined that a discrepant it em could pose a safet y or inst allat ion problem and the item is in use or has been shipped to the customer, correct.ive action will be taken as follows:

(a)

I f t he component is being operated by llNDC (trans-port at ion casks), use of the item wii stop i imne -

diately until the item is reinspected and either found t o be acceptable or repaired and retested,

if required.

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POLICIES AND PROCEDURES (b)

I f t he component has been shipped to the customer for his ownership and use (solidification system equipment), he will be notified immediately, in writing, of the discrepancy.

Due to the long shipping, storage, installation, and testing period for t his type of equipment, it is highly unlikely that the suspect item would be in-service prior to discovery of the calibrat ion discrepancy.

I f t here is any question, the customer will be not i fied by telecon wi th a follow-up in writing.

The completion of the above corrective action will be documented on the corrective action notice form.

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POLICIES AND PROCEDURES SECTION 14 CONTROL. OF SPECIAl. PROCESSES 14.1 Cencral:

When required by' applicable Regul,atory, Customer, and/or IINDC Requirements, special processes, including welding, nondest ructive examinat ion (NDE) and heat treating, will be performad in accordance with written procedures.

These will be developed in accordance with applicable codes, standards, or ot.her requi rement s and pacagraphs 14.2, 14.3 and 14.4 will be applicable.

14.2 Personnel Quali fications:

Personnel performing special processes will be qualified for that process in accordance with the requirements of the ASME Boiler and Pressure Vessel Code, the American Welding Society standards, SNT-TC-1A, or as required by another applicable code.

14.3 Procedure Qualifications:

Special process procedures will be qualified for its application in accordance with the requi rements of the ASME Boiler and Pressure Vessel Code, the American Welding Society standards, or as required by another applicable code.

14.4 Records:

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

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POLICIES AND PROCEDURES SECTION 15 INSTRUCTIONS, PROCEDURES AND DRAWINGS 15.1 General:

Activitles affeeting quality are control 1ed by documented instructions, procedures or drawings of types appropriate to the circumstances.

15.2 Quality Activities:

15.2.1 Documented instructions pertinent to safety and quality related items including criteria which form the basis for acceptance, will be prepared in accordance with Document Control Procedures.

15.2.2 Requirements incorporated into IINDC inst ruc-tions, procedures, or drawings are, where applicable, imposed on vendors and subcontrac-tors to the extent necessary to insure com-pliance with the contract requirements.

15.3 Document Procedures:

15.3.1 Instructions, procedures, or drawings for safety and quality related activities are described and implemented in the following documents:

a.

Procedures Quality Assurance (QA)

Procurement (Material Control and QA)

Administrative (Management and Engineering)

Design Control (Engineering)

Engineering Document Control (Engi-e neering)

Operations Procedures

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POLICIES AND PROCEDURES b.

Drawings and Specifications IINDC originated (Engineering)

Vendor and Subcontractor supplied (Vendor)

Customer supplied (Client) 15.4 Procedure Review:

15.4.]

The QA Manager will be responsible for review of procedures affecting IINDC Quality activities.

These procedures will be prepared by the responsible Section Managers.

15.4.2 The QA Manager will be responsible for insuring that the QA manual and procedures reflect current QA practices, lie will prepare or recommend revision of procedures as necessary.

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POLICIES AND PROCEDURES SECTION 16 DOCUMENT CONTROL 16.1 General:

Cont rol of the issuance of documents and changes thereto which af fect quality is an integral oart of the llNDC Quality Assurance Program.

16.2 Document control:

16.2.1 Verification of compliance with the document control procedures is the responsibility of the QA Manager.

Department Managers will establish the required document control procedures, and the QA Manager will monitor their implementaticn, and audit the system.

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

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

(a)

Specifications and/or Drawings t

(b)

Purchase Orders 1706 166 Quality Assurance Manual llNDC-0-001 (Sect. 16) 6 2

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POLICIES AND PROCEDUEES (c)

Test Procedures (d)

Inspection Reports (e)

Nonconformity and Disposition Reports (f)

Reject /lloid Tags (g)

Manufacturers Drawings (h)

Operating and Instruction Manuals (i)

Technical Standards (j)

Operational procedures pertaining to the unc of casks.

16.4.3 Documents in addition to those described above may be placed in a controlled status to suit specific requirements.

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'HNDC-0-001 (Sect. 16) 6 2

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POLICIES AND PROCEDURES SECTION 17 QUALITY ASSURANCE RECORDS 17.1 General:

The objective of maintaining a re. cord retention system is to provide an appropriate and easily retrievable quality history that will be available for cach quality or safety related item.

17.2 Quality Records:

17.2.1 IINDC will maintain a master file for all quality and safety related products.

This file will contain, 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 l

records will include 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 assure that QA documentation has been processed properly and that spec i fied inputs are part of the historical record.

17.3 Quality Record Files:

17.3.1 The Master File of Quality Records consists of the Purchase Order Master File, Qua1ity Assurance Mister File, Engineering Master Design File, and Contract File.

Quality Assurance Manual llNDC-0-001 (Sect. 17)

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168 170A TITLE PAG E _1. OF.2 NUMBER RE V.

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POLICIES AND ')ROCEDURES 17.4 Identi fiable and Retrievable:

17.4.1 QA/QC records will be filed in a manner that will allow records to be readily identifiable and retrievable.

17.4.2 The QA Manager will be responsible for assuring that standards are established including requirements for records and the maintenance of such records.

17.5 Retention of Records:

17.5.1 Records kept for retention will be maintained for the minimum period of time required by a customer's purchase order or specification, the applicable federal regulation, or for

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two years, if not otherwise specified.

17.5.2 Designated records (e.g.,

radiographs) may be stored at vendor or subcontractor facilities.

Such requirements shall be clearly stated in the purchasing documents and HNDC 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 life of the shipping package.

All other records will be maintained for a minimum of two years.

17.6 Protection of Records:

17.6.1 Protection and preservation of records as indicated in 17.5.2 will be the responsibility of HNDC.

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

1706 169 Quality Assurance Manual 0-001 (Sect. 17) 6 2

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POLICIES AND PROCEDURES SECTION 18 AUDITS 18.1 General:

The audit is a method for determining the ef fectiveness

, the Quali ty Assurance Program.

This will be accom-piished by reviewing, in detail, selected areas of performance and comparing the results with objectives outlined in this manual.

18.2 Unscheduled and Planned Audits:

18.2.1 HNDC has a responsibility for the implementa-tion of its QA program.

In order to exercise this responsibility and adequately control the program, unscheduled and planned audits will be conducted.

18.2.2 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 various factors including the criteria and seriousness of past infractions, but will be performed at least annually.

6 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.

18.3.2 A general list of attributes from Sections 1-17 are_used as a guide in the preparation of audits.

18.4 Audit Teams:

18.4.1 The QA Manager will be responsible for assuring the technical competence of audi t 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 18.4.2

' Assignment ~ of personnel to audit teams will reflect the realistic independence of the audit personnel in relationship to the person-nel, area, or organization being audited.

18.5 Audit Findings:

18.5.1 Audits will be conducted using formal check-lists.

Infractions noted will be documented, indicating type and nature of infraction and its relative seriousness.

18.5.2 Upon completion of the audit, the audit leader will conduct a critique of the findings to the organization being audited.

18.5.3 A formal report will be seat to the appropriate management levels for action and will include the Director of Radwaste Disposal and Support Services, the Director of Marketing and Projects, the Vice-President - Engineering, and the HNDC 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 determine compliance with the results of the initial audit findings.

18.6 Audit Records and Schedules:

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

18.6.2 The QA Manager will schedule, prepare, and maintain audits for engineering, design, procurement, etc.

1706 17i Quality Assurance Manual HNDC-Q-001 (Sect. 18) 6 2

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HITTM AN NUCLEAR & llEVELOPMENT CORPOR All0N COLUMBI A, MARY L AND 21045 POLICIES AND PROCEDURES i

QUALITY ASSURANCE MANUAL ADDENDUM FOR TRANSPORTATION CASKS LICENSED UNDER 10CFR PART 71 QUALITY ASSURANCE MANUAL ADDENDUM (llNDC-Q-001B)

Copy #8 U. S. Nuclear Regulatory Comm.

1706 172 PREPARED Quality Assurn(1ce Manager IINDC-Q-001B 1

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j PROCEDURE NUMBER R E V.

. 'I [g f - # 7 ; s e <- 84 <- !

APPROVED Dir. RW Disposal & Support Serv.

DATE 10/23/79 P AG E _1_ O F 6

POLICIES AND PROCEDURES I

1.0 Scope The Quality Assurance Program described in this manual (Procedure HNDC-Q-001) and addendum (Procedure HNDC-Q-001B) applies to the procurement, modification, main-tenance, and use of transportation casks, certified by the United States Nuclear Regulatory Commission, for use in accordance with 10CFR Par't 71.

2.0 Quality Assurance Program A monthly. review of the Quality Assurance Program will be performed by the Director of Radwaste Disposal and Support Services to assess the scope, status, imple-mentation, and effectiveness of the program to assure that it is adequate and complies with 10CFR Part 71 Appendix 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 specifications, drawings, and procedures; (2) quality standards are specified in the design documents and deviations and changes from these quality standards are controlled; (3) designs 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 identified; (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 each step.

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QA Manual Addendum HNDC-Q-001B 1

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POLICIES AND PROCEDURES 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) that approved changes are included in these documents prior to implementation of the change; and that (3) required documents are available at the location where the activity will be performed prior to commencing of the work.

Controlled documents are further identified in para.

16.4.2 of the manual.

The current revision number of instructions, procedures, specifications, drawings, and procurement documents will be identified on a master list maintained by the responsible department.

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

Procurement documents will identify the applicable re-quirements of 10CFR Part 71 Appendix E which must be complied with and described in a Supplier's Quality Assurance Program.

Also identified will be the documentation to be prepared, maintained, and submitted to the purchaser for review and approval 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, procedures, inspection and fabrication plans, inspection and test records, personnel qualifications, and material test reports or certifications.

As a minimum, the furnished records shall include documentation; (1) that identifies the purchased material or equipment and the specific procurement requirements met by the items, and (2) that describes any deviation from the procurement requirements and the disposition of the non-conformance

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

Procurement documents will specify llNDC's right of access to a supplier's facilities and records for source inspection and audit.

706 174 OA Manual Addendum HNDC-0-001P2 1

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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 fabrication, inspec-tion, testing, and shipment of materials, equipment, and components will be planned.

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

The receiving inspection of supplier-furnished mat-erial, equipment, and services will be performed to procurement documents in accordance with Ouality Assur-ance Procedures, which require the following:

(1) that the aaterial, component, or equipment is properly identified and corresponds with the identification on the purchase documents; (2) that material, components, equipment and. acceptance records are inspected 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 are available, and that; (4) items accepted and released are identified s

as to their inspection status prior to their removal from the inspection hold area to a controlled storage area, or releasing them for further 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, if 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 critical op-erations so that these actions may be controlled.

9.0 lla ndling, Storage, and Shipping Prior to the release of a transportation package to a customer for first use or following a repair or modifi-cation, the cask will be be inspected to assure that 1706 175 QA Manual Addendum HNDC-0-001B 1

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POLICIES AND PROCEDURES all conditions of the NRC package approval and the U.S.

Department of Transportation shipping requirements are satisfied.

This 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 NRC Certificate of Authorization with all referenced drawings and specifications will be supplied to the package user.

Following loading of the package, it is the responsiblity of the user to verify that the condi-tions detailed in the Certificate of Authorization, the routine determinations described in 10CFR Part. 71.54, and the U.S. Department of Transportation shipping requirements are satisfied prior to release of the shipment.

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 requirements of the U.S. Department of Transportation are met, and required survey data information.

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 package truck and trailer serial numbers.

Departure and arrival times will be

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monitored by the operations department in conjunction with the trucking dispatchers.

10.0 Quality Assurance Records 1.

Inspection and test records will contain the following where applicable:

(1)

A description of the type of observation.

(2)

Evidence of completing and verifying a manu-facturing, inspection, or test operation.

(3)

The date and results of the inspection or

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test.

1706 176 QA Manual Addendum HNDC-Q-001B 1

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POLICIES AND PROCEDURES (4)

Information related to conditions adverse to quality.

(5)

Inspector or data recorder identification.

(6)

Evidence as to the acceptability of the results.

11.0 Audits Internal Audits of the QA program will be performed at least annually based on the safety significance of the activity being audited.

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ML19256F196

Contents

Text

SUMMARY

1.1 General

1.2 Applicability

2.2 Organization

3.1 General

3.2 Responsibility

4.1 General

5.1 General

6.3 Traceabi1ity

7.2 Requirements

8.1 General

9.1 General

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ML19256F196

Text

SUMMARY

1.1 General

1.2 Applicability

2.2 Organization

3.1 General

3.2 Responsibility

4.1 General

5.1 General

6.3 Traceabi1ity

7.2 Requirements

8.1 General

9.1 General

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