ML20196A324

Application for Rev 5 to QA Program Approval for Radioactive Matl package:0230

ML20196A324
Person / Time
Site:	07100230
Issue date:	12/10/1987
From:	Bennett R, John Kramer, Trent L BABCOCK & WILCOX CO.
To:
Shared Package
ML20196A321	List: ML20196A318 ML20196A324
References
NUDOCS 8802040391
Download: ML20196A324 (34)

Text

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J QUALITY ASSURANCE PROGRAM FOR RADIOACTIVE MATERIAL PACKAGES N0. 0230, REVISION 5 NOVEMBER, 1987 ISSUE NUMBER ASSIGNED TO BABC0CK & WILCOX COMPANY NNFO RESEARCH LABORATORY i

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PREPARED BY:

1. EM%w GM//7

d. E. Kramer, QA Administra tor REVIEWED BY:

3. L, /bu31FN

/2// /I'7 R. L. Bennett, Manager, Safety & Licensing APPROVED BY:

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/2//a/6 7 L. K. Trent, Manager, Regulatory Relations

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QUALITY ASSURANCE PROGRAM FOR S:ction No.

i RADIOACTIVE MATERIAL PACKAGES Date NOV., 1987 TABLE OF CONTENTS Section Pa ge i

TABLE OF CONTENTS ---------------------------------------------

2 ii REVISIONS -----------------------------------------------------

3 111 I N T R 0 0 0 C T 10:4 --- - - - -- - -- - - - -- - --- - - - - - -- -- - - - - -- -------- - - --- - -

4 1.0 ORGANIZATION --------------------------------------------------

5 2.0 QUALITY ASSURANCE PROGRAM -------------------------------------

7 3.0 DESIGN CONTROL ------------------------------------------------

12 4.0 PROCUREMENT DOCUMENT CONTROL ----------------------------------

13 5.0 INSTRUCTIONS, PROCEDURES, AND DRAWINGS ------------------------

14 6.0 DOCUMENT CONTROL ----------------------------------------------

16 7.0 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES --------

18 8.0 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS AND COMPONENTS -

21 9.0 CONTROL OF SPECIAL PROCESSES ----------------------------------

23 10.0 INSPECTION ----------------------------------------------------

23 11.0 TEST CONTROL --------------------------------------------------

24 12.0 CONTROL 0F MEASURING AND TEST EQUIPMENT -----------------------

25 13.0 HANDLING, STORAGE, AND SHIPPING -------------------------------

27 14.0 INSPECTION, TEST, AND OPERATING STATUS ------------------------

28 15.0 NONCONFORMING MATERIALS, PARTS OR COMPONENTS ------------------

29 16.0 CORRECTIVE ACTION ---------------------------------------------

30 17.0 QUALITY ASSURANCE RECORDS -------------------------------------

31 18.0 AUDITS -------------------------------------- ----------------

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sta7 NNFD RESEARCH LABORATORY QUALITY ASSURANCE PROGRAM FOR RADIOACTIVE MATERIAL PACKAGES SECTIOtJ tJO, REVISIOtJS ii DATE NOV.

1987 DATE DESCRIPTIOtJ APPROVED I

12/78 ORIGINAL RELEASE 01/80 REVISION 1

~ Revised to include NRC's comments of 11/01/79.

05/80 REVISION 2 Added index to Section 2.0 per NRC's comments of 03/14/80.

08/85 REVISION 3 Updated implementing procedure li s ting.

Revised to reflect changes in reporting responsibilities of Quality Assurance Administrator, SNM Accountability Specialist, and Health Physics.

10/86 REVISION 4 Updated implementing procedure listing.

Revised Section 1.0 to reflect changes in reporting responsibilities of the LRC Quality Assurance Administrator and the Manager, Safety and Licensing.

11/87 REVISION 5 Complete revision to reflect changes due to transfer of responsibility from the R&DD to NNFD.

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• Approval signatures on cover page. __

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% s/87 QUALITY ASSURANCE PROGRAM FOR Sec% ion No.

iii RADIOACTIVE MATERIAL PACKAGES Da te MOV., 1987 INTRODUCTION

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j This manual describes t,he Quality Assurance (QA) Program

r shipping packages which transport certain quantities of radioactive material that is currently in effect at the Babcock & Wilcox Company NNFD Research Laboratory (Site).

The QA l

Program imposes standards of quality through the development of policies, pro-cedures and instructions, and the implementation of effective plans and disci-plines.

This manual meets the requirements of 10 CFR Part 71, Subpart H, "Quality Assurance."

It should be noted that for any specific package, not all of the sections of this manual will necessarily be imposed. The QA Program, however, requires the develop-ment of a formal QA Plan which shall specify the applicable sections of this manual.

The Quality Assurance Administrator has the responsibility and authority for the l

administration and assurance of conformance with the requirements of the program described in this manual.

He has the authority and responsibility to require corrective action for shipping packages which do not conform to the objectives and policies outlined in this manual.

Comnliance with the intent of these objectives is also required of suppliers to the Site throup equirements transmitted in pro-curement documents.

The sa fety of employees, the public, and Company operations are of paramount im-portance to the Company.

An Industrial Safety and Health Program has been estab- --

lished at the NNFD-RL to assure safe practices and implement accident prevention.

Operations are performed 'according to guidelines contained in the NNFO-RL Industrial Safety Manual, i

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1.0 RADIOACTIVE MATERIAL PACKAGES Date HOV., 1987 ORGANIZATION Implementation and maint'enance of the QA Program for manufacture, use, and repair of radioactive material shipping containers is the responsibility of Site manage-l ment.

Containers for shipment of NRC licensed material may be designed and con-structed by a Site approved contractor or designed, constructed, purchased, repaired or used by the Site.

However, responsibility for quality assurance resides with Site management.

The Site is organized as shown in the organization chart (Figure 1).

Written pro-cedures listed in Table 1 delinea te the function and responsibilities of the organizations at the Site.

All personnel performing shipping container QA functions are considered to be qualified in this area because current programs for the application of 10 CFR 50, Appendix B are in effect.

All verifications of conformance to established require-ments are accomplished by individuals or groups who do not have direct responsi-bility for performing the work being verified. Trained, qualified personnel at the Site shall determine if functions delegated to suppliers are being accomplished.

The principle responsibilities and authorities of the Site Quality Assurance l

Program for Shipping Packages are vested in the following positions at the Site.

Quality Assurance Administrator The responsibility for implementing the Quality Assurance Program lies with the Quality Assurance Administrator.

He reports to the Panager, Regulatory Relations.

He is separated from all other groups thus assuring independence in carrying out the functions of inspecting, auditing, and verifying conformance to 10 CFR 71, Sub-part H criteria.

He is responsible for the implementation of the QA Program, in-cluding review and approval of vendor quality assurance programs.

He has the authority to withhold from further processing or use the materials, parts, or com-2 ponents which do not meet the applicable requirements. The qualifications for

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1.0 RADIOACTIVE MATERIAL PACKAGES Da te HOV., 1987 Quality Assurance Administrator include a B.S. degree or equivalent, or the ability to substitute equivalent experience; and a minimum of two years quality-related experience in industry.

1 SNM Accountability Specialist The responsibility for selecting and ordering shipping containers lies with the SNM Accountability Specialist.

He completes required forms prior to shipment.

Health and Safety Health and Sa fe ty personnel are responsible for moni toring and verifying the nuclear and radiological safety of the shipping packages. Typical duties include:

radiation surveys, labeling of shipping containers and vehicles, generation and retention of Health and Safety documentation, and enforcement of Health and Safety and nuclear safety standards.

1 FIGURE 1 Regulatory Relations Ma nager' i

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Quality Assurance Safety & Licensing Administra tor Manager Health & Safety Accountability Supervisor Specialist I

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RADIOACTIVE MATERIAL PACKAGES Da te NOV., 1987 e

i QUALITY ASSURANCE PROGRAM The Site Quality Assurance Program for Radioactive Material Packages documented in l

this manual is in accordance with Corporate Quality Assurance policies, goals, and objectives.

The QA Program regulates activities associated with the design, pro-curement, manufacture, production, testing, inspection, preservation, and handling of nuclear components and services.

Compliance with the requirements of this QA l

Program is mandatory for all Siite organizations and personnel.

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A Qualt ty Assurance Plan shall be developed for projects that require the applica-tion of QA according to the guidelines in this Program.

It should be noted that not all sections of this Program will be required for all projects.

The project leader and Quality Assurance shall prepare a QA plan that imposes the QA require-ments for a project.

t Implementation of quality assurance is primarily the responsibility of the project leader.

The project leader shall assure that the required activities and training are performed and documented, and that inspections are performed by persons inde-pendent of the activity process.

1 Indoctrination and training programs require:

Instruction of organizations and personnel responsible for performing quality a.

related activities.

Instruction includes the purpose, scope, and mandatory implementation of the quality related manuals, instructions, and procedures, b.

Personnel performing quality related activities be trained and qualified in the principles, techniques, and regulatory requirements of the activity being performed.

i The scope, the objective, and the method of implementing the indoctrination l

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i and training program be documented.

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RADIOACTIVE MATERIAL PACKAGES Date NOV., 1987 d.

Proficiency of personnel performing quality related activities by maintained by retraining, and/or re-certifying.

Sa fety-related structures, systems, and components controlled by the QA Program shall include, as a minimum, structural requirements to maintain container integri-ty, radiation shielding, and neutron absorbents.

Controls shall be maintained over suppliers and consulting organizations, to assure that 10 CFR 71, Subpart H is implemented.

Management reviews of the QA Program are conducted periodically to assess its scope, implementation, and effectiveness.

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RADIOACTIVE MATERIAL PACKAGES Date NOV., 1987 TABLE 1.

INDE' f.ROSS-REFERENCING APPENDIX E CRITERIA WITH IMPLEMENTING PROCEDURES Cri teria Procedures Applicable to NNFO Research Laboratory

1. Organization 0101-02 NNFD-RL Purpose and Responsibilities

2. Quality RL-IP-1702-01 Operational Quality Program (00P) for the Assurance NNFD Research Laboratory Program RL-IP-1702-03 Preparation of Quality Assurance Program Plans RL-IP-1702-04 Operational Quality Program (0QP) for Radioactive Material Packages NNFD-RL Industrial Safety Manual

3. Design RL-IP-0405-01 Design Review Program Control RL-IP-1704-02 Preparation of Project Technical Plans RL-IP-1704-03 Independent Technical Reviews RL-IP-1704-04 Documentation of Calculations

4. Procurement NNFD-AP-1211-01 Requisitions Document Control

5. Instructions, RL-IP-1706-01 Technical Procedures Procedures RL-IP-1706-02 Drawing Prepar:stion and Control and Drawings RL-IP-1706-08 Preparation of Calibration Procedures RL-IP-1706-09 Procedures for the Preparation, Approval and Control of Area Operating Procedures RL-IP-1706-10 Procedures Required for Compliance with Federal Regulations RL-IP-1709-03 Route Sheets RL-IP-1711-01 Inspection Checklists

6. Document RL-IP-1702-03 Preparation of Quality Assurance Program Control Plans RL-IP-1702-04 Operational Quality Progr1m (0QP) for Radioactive Material Packinges RL-IP-1704-02 Preparation of Project Terhnical Plans RL-IP-1705-01 Procurement Document Control RL-IP-1706-01 Technical Procedures RL-!P-1706-02 Drawing Preparation and Control RL-IP-1706-09 Procedure for the Preparatico, Approval and Control of Area Operating Prtcedures l

RL-IP-1706-10 Procedures Required for Compliance with I

Federal Regulations RL-IP-1709-03 Route Sheets I

j RL-IP-1711-01 Inspection Checklists

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OUALITY ASSURANCE PROGRAM FOR sta7 Section No.

2.0 RADIOACTIVE MATERIAL PACKAGES Da te NOV., 1987 Cri teria Procedures Applicable to NNFD Research Laboratory

7. Control of NNFO-AP-1211-01 Requisitions Purchased RL-IP-1214-01 Receiving Ma terial,

RL-IP-1216-01 Shipping Equipment,

,RL-IP-1216-03 Transportation of Radioactive Materials and Services RL-IP-1708-01 Supplier Control RL-IP-1708-02 Approved Supplier List

8. Identification RL-IP-1217-09 Government-Owned Equipment and Control of RL-IP-1709-01.%terial Identification Tags Ma teri61s, Parts, RL-IP-1709-02 Control of Customer-Furnished Property and Components RL-IP-1715-01 Inspection Acceptance Tags RL-IP-1715-02 Discrepancy Tags

9. Control of RL-IP-1706-01 Technical Procedures Special Processes

10. Inspection RL-IP-1711-01 Inspection Checklist RL-IP-1711-02 Inspection RL-IP-1715-01 Inspection Acceptance Tag RL-IP-1715-02 Discrepancy Tag

11. Test Control RL-IP-1706-01 Technical Procedures RL-!P-1706-09 Procedure for Preparation, Approval and Control of Area Operating Procedures RL-IP-1706-10 Procedures Required for Compliance with Federal Regulations RL-IP-1712-01 Test Control RL-IP-1712-03 Logbooks / Laboratory Notebooks

12. Control of RL-IP-1713-01 Measuring Equipment Control and Calibration Measuring and RL-IP-1713-02 Out-of-Calibration Report Test Equipment RL-IP-1713-04 Use of Thermocouples RL-IP-1713-05 Manome ters RL-IP-1713-06 Strain Gages RL-IP-1718-01 Instrument Service Log

13. Handling, RL-IP-1214-01 Receiving Storage and RL-IP-1216-01 Shipping Shipping RL-IP-1216-03 Transportation of Radioactive Material RL-IP-1706-01 Technical Procedures RL-IP-1711-01 Inspection Checklist i

14. Inspection, RL-IP-1714-01 Receiving Inspection Reports Test, and RL-IP-1715-01 Inspection Acceptance Tags Opera ting RL-IP-1715-02 Discrepancy Tag Sta tus i

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2.0 RADIOACTIVE MATERIAL PACKAGES Date NOV., 1987 Criteria Procedures Applicable to NNFD Research Laboratory

15. Nonconforming RL-IP-1715-02 Discrepancy Tag Ma terial s,

RL-IP-1716-01 Control of Nonconforming Items Parts or RL-IP-1716-02 Reporting of Defects and Noncompliance Components Pursuant to 10 CFR 21

,RL-IP-1717-01 Corrective Action System

16. Corrective RL-IP-1716-02 Reporting of Defects and Noncompliance Action Pursuant to 10 CFR 21 RL-IP-1717-01 Corrective Action System

17. Quality RL-IP-1718-03 Quality Assurance Records Assurance Records

18. Audits RL-IP-1719-01 QA Audits-Internal RL-IP-1719-02 QA Audits-Supplier J

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RADIOACTIVE MATERIAL PACKAGES Date NOV., 1987 DESIGN CONTROL

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l Design activities at the Site are conducted in accordance with procedures which assure applicable quality standards and design features are translated into speci-fications, drawings, procedures, and instruction.

Any deviations or changes from these quality standards are controlled.

Design reviews are made by individuals or groups other than those involved in the original design and are specifically directed to those items critical to the quality of the component or system being designed.

Suitable design controls are applied to such activities as seismic, stress, thermal, hydraulic, radiation, and accident analysis, compatibility of ma-terials, and accessibility for in-service inspection, maintenance and repair.

Designs are also reviewed to assure (1) design characteristics can be controlled, inspected, and tested. (2) inspection and test criteria are identified. Ma terial s, parts, and equipment which are standard, connercial, or which have been previously approved for a different application are reviewed for suitability prior to selec-tion.

Measures are established for the selection of suitable materials, parts, equipment, and processes for safety-related s tructure s, systems, and components i

t including the use of valid industry standards and specifications.

Selection and accomplishment of design verification or checking processes by design reviews, alternate calculations or qualification testing are performed.

When a test program is used to verify the adequacy of a design, a qualification test of a prototype unit under adverse operating conditions shall be used, a

Design interface controls include the review, approval, release, distribution and revision of documents with participating design organizations.

Design and specifi-l cation changes are subject to the same design controls and approvals applicable to the original design.

Errors or deficiencies in the design, including the design process, that could adversely affect safety-related structures, systems, and com-ponents are documented and handled in accordance with Section 16.0 of this manual. _

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4.0 RADIOACTIVE MATERIAL PACKAGES Date NOV., 1987 PROCUREMENT DOCUMENT CONTROL Quality Assurance shall r,eview and approve purchasing documents prior to release to verify inclusion of basic technical requirements, provisions for access to the suppliers facility for source inspection or audit, documentation submittal / retention requirements, quali ty assurance program requirements, provisions for extending applicable requirements to lower tier suppliers, requirements for material certifi-cations or certificates of conformance, and other applicable 10 CFR Part 71, Sub-part H rsquirements.

Qua' - e issurance shall verify the proposed supplier has been evaluated and approved pee Se provisions of Section 7.0 of this manual and shall notify Purchasing if an a

aved supplier must be used for the purchase.

I Procurement documents for spare or replacement parts of safety-related structures.

l systems, and components are subject to controls at least equivalent to those used for the original equipment.

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Changes to purchase requisitions or purchase orders shall receive the same level of approval as the original document.

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RADIOACTIVE MATERIAL PACKAGES Date NOV.

1987 i

1 INSTRUCTIONS, PROCEDURES, AND DRAWINGS l

Activities at the Site are directed by documented instructions, procedures, and

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drawings appropriate to the circumstances to which they are applied.

Fabrication Drawings are prepared by the appropriate organizations and checked for safety, functional and structural adequacy, and dimensional accuracy for critical components. Drawings are reviewed by responsible groups to verify design require-ments. ' Revision level and approvals are applied to the drawings prior to release for f abrication.

Revisions to drawings 0.re sub. ject to the same level of approval as original drawings prior to implementation of changes.

If Quality Assurance determines fabrication, assembly, or process control is re-quired, the drawings shall contain a note stating that route sheets are required.

I Route Sheets shall reference the drawing and revision number to be used, indicate the sequence of operations to be followed, provide a place for recording data, reference technical procedures (including ravision) to be used in performing the operation, identify acceptance criteria (if not on the drawing or in the technical procedure), and provide for the initials of the person completing the operations, j

If an independent inspection function is to be employed, the route sheet shall provide for initials of the inspector evaluating the operation.

I Inspection Checklists are used for verifying recording of physical characteristics considered critical to the component.

Checklists can be used in place of route i

sheets when the inspection is performed af ter the part has been completed with no l

l in-process control of fabrication.

l Implementing Procedures are used to implement policies and to direct the activities l

l of one or more organizations.

They describe interface requirements and provide the detailed work instructions for recurring functions.

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' s/a7 QUALITY ASSURANCE PFi40RAIA TOFi Secdon Jia, 5,, 0

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i Technical Procedures are used to direct specific technical activities such as the performance of experiments or tests, calibration of equipment, error analysis, or special process control; (i.e., welding, nondestructive examination, etc.).

When used as test performance procedures, the technical procedures shall include pro-visions for assuring test prerequisites have been met (refer to Section 11.0).

provisions for recording data either on test data sheets or in test logs, and provisions for customer witnessing of the test are met as required. When material control is required during the performance of a test or experiment, the test i

procedures shall direct the handling and identification of the controlled material.

i The QA organization shall review and concur with technical procedures, inspection plans, drawings and specifications and changes thereto.

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NNFD RESEARCH LABORATORY

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6.0 R ADIOACTIVE MATERI AL PACKAGES Da te NOV., 1987 DOCUMENT CONTROL The documents affecting quality controlled by the provisions of this section are:

Implementing Procedures I.

Drawings Inspection Checklists Quality Assurance Manual Quality Assurance P1ans Route Sheets Technical Procedures Implementing Procedures are prepared and revised by personnel reporting directly to t.ie Manager, Regulatory Rela tions.

The resolution of conflicting requirements shall be the responsibility of the Manager, Regulatory Relations.

The editing, arranging, and issuing of procedures to authorized personnel is the responsibility of the QA Administrator.

The QA Administrator is also responsible for obtaining approval signatures on the ester file copy and for retention of historical file copies.

Drawing: are prepared by appropriate organizations and controlled by Plant Engi-neering.

Revision level and approvals are reflected on the drawings and on status cards maintained by Plant Engineering.

Original releases and revisions must be approved by the design engineer and the responsible personnel.

The QA Administra-tor maintains a distribution list to assure the latest approved revision applicable to a specific job is used. Drawings are retained as required by contract require-ments or Site retention policy.

Inspection Checklists are prepared and revised by the responsible group and approved by the individual specifically responsible for the container.

The checklists are issued to the person performing the verification.

Completed checklists are returned to the responsible section for inclusion in the project file. __ -

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6.0 RADIOACTIVE MATERIAL PACKAGES Date NOV., 1987 Quality Assurance Program Manual The Quality Assurance Prograr1 description is prepared by Quality Assurance and approved by the Manager, Regulatory Relations.

The Quality Assurance Administrator maintains the distributi,on lists and issues copies of the manual on a controlled and uncontrolled basis.

Controlled manuals have an issue number assigned to each recipient and are kept up-to-date.

Uncontrolled copies are issued on a one-time basis for information only. A record of recipients of uncontrolled copies shall be r.c i n tai ned.

Revisio'1s of the manual are subject to the same control as the origi-nal release.

Quality Assurance Plans are prepared by the Quality Assurance Administrator with input from those personnel responsible for the use, repair, design or construction of the container.

The responsible group maintains the distribution lists.

Re-visions are subject to the same control as the originals.

Route Sheets are prepared when fabrication, assembly, or process control is re-quired.

Route sheets shall be reviewed and approved by Quality Assurance prior to release to the project construction supervisor.

Revisions to route sheets shall receive the same control as the originals.

Technical Procedures.

Initiation and approval of a technical procedure is the responsibility of the using organization.

The originator is responsible for the technical con ten t, revision, approvals, and identifying distribution.

Quali ty Assurance shall provide the originator with a unique identification number.

Once the procedure has been approved, Quality Assurance shall obtain final release, re-production and distribution of copies.

Revisions require the same levels of ap-proval as the original.. _ - _ - __

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7.0 RADIOACTIVE MATERIAL PACKAGES Date NOV., 1987 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES When required, pre-award, audits and surveillance of suppliers during fabrication, inspection, testing, and shipment of materials, equipment and components will be planned and performed in accordance with written procedures to assure conformance to quality and purchase order requirements.

These procedures provide for instruc-tions specifying the characteristics or processes to be witnessed, inspected, or verified, and accepted; the method of surveillance and the extent of documentation required; and individuals responsible for implementing these instructions.

Sup-pliers are periodically evaluated by audits, independent inspections, or test to assure their certificates of conformance are valid.

Source Evaluation and Selection If evaluation and selection of suppliers is required by the Quality Assurance Plan, one of the icllowing criteria shall be used:

The supplier must have a previous and continuous record of supplying acceptable a.

items, processes, or services to the requirements of the Site procurement docu-ments. For purposes of meeting this criterion, the Site may elect to use sup-plier quality history data obtained from other B&W divisions provided the data is for similar items, processes, or services purchased.

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If deemed necessary, an audit of the supplier's quality assurance system at his facility shall be performed to determine acceptability.

For commercial or "off the shelf" items, a receiving inspection should be per-c.

formed to determine compliance with procurement document requirements.

Approved Supplier List Once a supplier has been evaluated and approved, Quality Assurance shall add the supplier's name to the Site Approved Supplier List.

The list will be distributed to appropriate personnel at the Site and to the Purchasing Department.

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7o0 RADIOACTIVE MATERIAL PACKAGES Date NOV., 1987 orders for items requiring quality assurance per this section must be placed with suppliers shown on the Approved Supplier List, Supplier Audits If an audit of a supplier's quality system is required by the Site, the audit shall l

be coordinated with Quality Assurance, Purchasing, and the cognizant project leader.

The audit shall be performed in accordance with Section 18.0 of this manual.

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plier audits for DOT specification containers are not performed.

Source Inspection When source inspection is required, an inspection plan shall be developed by the project leader and Quality Assurance.

It will designate specific witness and hold points.

Copies of the source inspection reports shall be maintained on file by the project leader and Quality Assurance.

Surveillance shall be performed on items for which verificaticn of procurement requirements cannot be determinea upon rectipt.

Receivj.t Inspection Receiving inspection of the supplier furnisheJ material, equipment, and services is performed to assure:

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The material, component, or equipment is properly iuentifbe and corresponds with the identification on receiving documents.

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Ma terials, components, equipment, and acceptance records are inspected and judged acceptable in accordance with pre-determined inspection instructions, prior to installation or use.

c.

Inspection records or certificates of compliance attesting to the acceptance of materials, components, and equipment are available prior to installation or use.

d.

Items accepted and released are identified by inspection status prior to for-warding to a controlled storage area or releasing for installation or fabri-cation. -

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700 RADIOACTIVE MATERIAL PACKAGES Da te NOV, 1987 Requirements for receiving inspection shall be noted on the purchase order.

A copy of the purchase order shall be forwarded to the receiving group.

Upon arrival, items shall be segregated and not released 'or use until accepted by inspection.

If specific procedures are required to perform the inspection, they shall be pro-vided to the inspector prior to commencement of the receipt inspection.

A notation of special instructions and requirements shall be made on the purchase order.

Supplier Procedures Requirements for suppliers to submit specific procedures for Site review and ap-l proval shall be included (as applicable) on the purchase order. When the procedures are received, they shall be routed to the project leader for review and approval.

Supplier QA procedures shall be reviewed by Quali ty Assurance and the project leader.

Supplier QA manuals shall be routed to QA for review, approval and reten-tion.

Records Suppliers shall furnish the following records:

Documentation identifying the purchased material or equipment and the specific a.

requirements (e.g., codes, standards, and specifications) met by the items.

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Documentation identifying procurement requirements which have not been met to-gether with a description of those nonconformances dispositioned "accept as is" or "repair."

The review and acceptance of these documents shall be described in the QA Program and shall be undertaken by a responsible QA representative.

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8.0 RADIOACTIVE MATERIAL PACKAGES Date NOV., 1987 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS AND COMPONENTS Material shall be contro,lled using a system of tags, route sheets, and technical procedures to assure accurate recording of traceability of material by part number, lot number, serial number, or heat number.

Identification must be verified and documen ted.

Identification requirements are determined during generation of speci-fications and design drawings.

Procedures direct the use of a tagging system to be applied to all controlled ma-

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terials.

When route sheets or technical procedures are used, material identifi-ca tion shall be transferred to route sheets, test data sheets, or test logs to maintain accountability and control during fabrication and assembly or during the performance of a test or experiment. Upon completion of the activity, the parts or material shall be re-identified to reflect their resulting condition.

The location and the method of identification shall in no way affect the fit, function, or quality of the item being identified.

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900 RADIOACTIVE MATERIAL PACKAGES Da te NOV, 1987 CONTROL OF SPECIAL PROCESSES Special processing techniques used to support fabrication or performance of an ex-periment or test shall be documented in technical procedures with the requisite approvals. Qualification of the equipment to be used shall either be in accordance with the direction provided by the technical procedure or by standard calibration procedures used as a part of the normal measurement control program defined in Section 12.0 of this manual.

If personnel qualifications are required (such as for

weldingJ, appropria te qualifica tion records shall be maintained reflecting examination results, training records, and maintenance of proficiency.

In most areas, the performnce of a special process (for example, NDE) isby labora tory personnel directly engaged in the research aspects of the process who are, by na ture of their work, qualified well above standards imposed on production facili-ties.

These qualifications are on file in the Personnel Department. When required in direct support of an experiment or test, appropriate process control records shall be maintained.

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10.0 RADIOACTIVE MATERIAL PACKAGES Date MOV., 1987 INSPECTION l

Inspections are performe,d on those activities affecting quality to assure con-l formance with documented instructions, procedures, and drawings.

The need for in-spection is identified on the receiving copy of the purchase order, route sheets, technical procedures, and/or inspection checklists.

Mandatory inspection hold points for witness by an inspector shall also be identified on these documents.

Critical dimensions are identified on the drawings.

Any modifications, repairs, or replacements shall be inspected in accordance with the original design and inspec-tion requiremen ts or acceptable al terna tive s.

When direct inspection is not possible, indirect con trol shall be achieved by monitoring processing methods, I

equipment, personnel, etc.

Inspection shall be performed by a person (s) familiar with the operation being inspected.

Inspectors shall be qualified in accordance with applicable codes, standards, and training programs.

Qualifications and certifications shall be kept current.

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11.0 RADIOACTIVE MATERIAL PACKAGES Date NOV., 1987 TEST CONTROL Test control is provided,by technical procedures (reference Section 5.0).

Responsi-bility for preparation of the test program and the test performance procedure is assigned to the project leader who obtains the necessary approvals.

The revision and distribution control is described in Section 6.0 of this manual.

Each test procedure shall include provisions for ensuring test prerequisites have been met.

Prerequisites include items such as calibrated instrurrentation, appropriate equip-ment, trained personnel, condition of test equipment and the item to be tested, sui table environmental conditions and provisions for data acquisition.

Wri tten test procedure shall incorporate the following:

a.

The requirements and acceptance limits contained in applicable designs and procurement documents, b.

Instructions for performing the test.

c.

Manda tory inspection hold points for witness by owner, con trac tor, or inspector.

d.

Acceptance and rejection criteria.

Test data and results shall be documented using test logs, data sheets, or a com-puter data acquisition system. These data shall be analyzed by the project engineer and reviewed by his supervisor to ensure test objectives have been met.

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12.0 RADIOACTIVE MATERIAL PACKAGES Date NOV., 1987 CONTROL OF MEASURING AND TEST EQUIPMENT A documented system is e.stablished and maintained to assure tools, gauges, instru-ments, inspection and measuring and test equipment used in activities affecting quality are of the proper range, type and accuracy to verify conformance to estab-lished requirements.

This system, as a minimum, meets the requirements of Specification MIL-STD-45662, "Calibration System Requirements."

The system includes calibration and certification records, calibration procedures, and a recall system to assure equipment is calibrated within established intervals.

The accuracy of calibrated equipment is assured by one of the following:

a.

Traceability to standards maintained by the National Bureau of Standards.

b.

Comparison to natural physical phenomenon.

c.

The ratio type of self-calibration techniques.

Items within this system are given a unique serial number for traceability to cali-bration test data.

Calibrations are recorded on a service log form showing the i

serial number of the item and the procedure to which it is calibrated.

A label is applied to the item to indicate the calibration status, including calibration due date. The complete status of items under the calibration system is maintained.

If inspection and measuring and test equipment is found to be out of calibration, an out-of-calibration report is issued by the Calibration Lab.

An evaluation of i

the validity o' previous inspection or test results and of the acceptability of items previously inspected or tested is made and documented.

If inspection and measuring or test equipment is consistently found to be out of calibration, it is repaired or replaced.

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12.0 RADIOACTIVE MATERIAL PACKAGES Da te NOV., 1987 Calibration standards have an uncertainty (error) requirement of no more than one-fourth of the tolerance of the equipment being calibrated.

A greater uncertainty -

may be acceptable when limited by "state-of-the-art."

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, ya7 QUALITY ASSURANCE PROGRAM FOR Section No.

13.0 RADIOACTIVE MATERIAL PACKAGES Da te H0V., 1987 HANDLING, STORAGE, AND SHIPPING Special handling, storagg, shipping, packaging, preservation, or cleaning instruc-tions required for containers are identified by the project leader.

The project leader either issues a technical procedure detailing these requirements or coordi-nates with the designers to have the requirements defined on drawings.

Tne tech-nical procedures include provisions for recording inspection data when such inspection is required.

If drawings are used, the drawings shall require route sheets 'or inspection checklists to document accomplishment of tasks and the inspection (if necessary) of the activity.

Special handling and loading procedures for NRC approved containers are documented in the specifica tion, Certificate of Compliance, or referenced procedure.

Co m-pletion of these requirements is assured by the project leader and are documented.

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14.0 s

RADIOACTIVE MATERIAL PACKAGES Date NOV., 1987 INSPECTION, TEST, AND OPERATING STATUS If required by contract gr work order involving material control, a system of mark-ings, tags, route sheets, inspection checklists, test data sheets, test logs, or inspection records are used to identi fy the inspection and test s ta tu s.

This system assures nonconforming items are clearly marked and only items having passed the required inspections or tests are used.

This system includes written procedures for control of the above listed status indicators, lypassing of required inspec-tions, tests, and other critical operations is procedurally controlled under the cognizance of the Quality Assurance organization.

When required, this system also includes a means for indicating operating status of test systems.

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15.0 RADIOACTIVE MATERIAL PACKAGES Da te NOV., 1987 NONCONFORMING MATERIALS, PARTS OR COMPONENTS Nonconforming items shal.1 be tagged with a red "discrepancy" tag, segregated when-ever possible, and the nonconformance documented on a Corrective Action Report (CAR).

The CAR identifies the nonconforming item, describes the nonconformance, the disposition of the nonconformance, the inspection requirements, and includes signature approval of the disposition.

The project leader shall review nonconformances to determine adverse effects to the test re sul ts, finished products or repairs.

The project leader shall approve actions taken to correct the nonconformance or to "use-as-is "

Quality Assurance shall approve all Corrective Action Reports and, when the nonconformance is satis-factorily resolved, shall remove the "discrepancy" tag from the item.

In instances requiring a "repair" or "use-as-is" decision, the project leader shall determine whether such a decision causes a deviation to customer requirements or commitments made in the proposal or project technical plan.

If a deviation exists, the project leader must obtain approval from the customer before implementing the "repair" or "use-as-is" decision.

Acceptability of rework or repair of materials, parts, components, systems, and s truc ture s, is verified by re-inspecting and re-testing the item as originally inspected and te >ted, or by a method which is at least equal to the original inspection and testing method.

Inspection, testing, rework, and repair procedures shall be documented.

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16.0 RADIOACTIVE MATERIAL PACKAGES Date NOV., 1987 CORRECTIVE ACTION There are three facets to the corrective action system.

The first is the corrective action obtained for a specific hardware nonconformance (see Section 15.0).

Quali ty Assurance shall verify the appropriate corrective action has been taken before final acceptance of the Corrective Action Report.

The second facet is corrective action obtained during formal audi ts.

Quali ty Assurance performs periodic audits as described in Section 18.0 of this manual.

When quality system deficiencies are detected, they are identified in the audit report.

The response to audit findings is evaluated by Quality Assurance for ade-quacy.

Af ter the time for implementation of the corrective action has elapsed, Quality Assurance shall verify the action was taken and is ef fective.

The third facet of corrective action is a quality system deficiency detected by means other than a specific nonconformance or audit finding. When an incident has occurred or a condition exists which could jeopardize the attainment of Quality Assurance objectives, Quality Assurance shall initiate a Corrective Action Report describing the deficiency and shall forward the report to the cognizant project leader, group supervisor or section manager.

Note:

Deficiencies involving multiple projects, tests, programs or sections shall be reported to the appropriate section manager (s) for corrective action. The recipient shall (1) conduct an investigation of the cause of the incident or condition, (2) document on the report form the re-suits of the investigation and the corrective action, and (3) forward the report to

)

Quality Assurance.

Quality Assurance shall follow up within a reasonable time to assure the corrective action has been implemented and is effective.

If a quality system deficiency is considered to be significant, Quality Assurance will immediately notify the cognizant project leader, group supervisor, section manager, and laboratory manager and shall require a work stoppage in the affected area of operation until the condition has been corrected.

A report of this action shall be rade to the Manager, Regulatory Relations within forty-eight hours.

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17.0 RADIOACTIVE MATERIAL PACKAGES Da te NOV., 1987 QUALITY ASSURANCE RECORDS The Site has a system f,or preparation, collection and retention of records suf-

-l ficient to provide documentary evidence of activities affecting quality and (where applicable) of the acceptability of materials, parts, or assemblies having an effect on the validity of the test or experiment.

These records shall be consis-tent with applicable codes, standards, specifications, and contracts and shall be adequate for use in managing the program.

The records shall be identifiable and re trievable.

The system encompasses those records required by each section of the manual, but specific records shall be generated only if the applicable section of this manual is invoked by the Quality Assurance Plan for the project.

QA records may include

(.s cpolicable) results of reviews, inspections, tests, audits, material analyses and m /,itoring of work performance, qualifications of personnel, procedures, and equipment, and other documentation such as drawings, specifications, procurement documents, calibration procedures and reports, nonconformance reports, and correc-tive action reports.

Inspection and test records shall, as a minimum, identify the inspector or person recording data, the type and date of observation, the results, the acceptability, and the action taken in connection with any deficiencies noted.

j Permanent retention of records shall be in accordance with B&W policy and as re-d quired by contract work order or applicable codes, standards or specifications.

B&W policy provides for permanen t record retention in an es tablished storage facility located and secured to prevent destruction of the records by fire, flooding, thef t, and deterioration by environmental conditions such as temperature or humidi ty. --

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18.0 RADIOACTIVE MATERIAL PACKAGES Date NOV., 1987 AUDITS Quality Assurance shall, implement a system of audits to verify compliance with the Quality Assurance Program and to include an objective evaluation of quality related practices, procedures, and instructions and the effectiveness of implementation.

Audits shall, more specifically, consist of an objective evaluation of work areas, activities, processes, and items and the review of comments and records.

"Tie audits shall be performed in accordance with written procedures or checklists by a ppropria tely trained personnel having no direct responsibilities in the areas being audited. The audit team may employ other personnel with additional technical expertise to ensure a comprehensive assessment of the activity.

Internal audits shall be performed on individual projects to verify compliance with the Quality Assurance Plan.

Audits shall also be performed on selected systems which apply to more than one project.

Project audits shall be performed at least once during the project or at least once annually, whichever is the shorter in terval.

Supplier audits shall be performad when required by tne provisions of Section 7.0 of thi s manual.

Site procurements do not require long supplier production runs; therefore, the Site policy is to perform a pre-award evaluation and then monitor the supplier's quality system using selected source inspections and receiving in-spection data.

Supplier audits must be performed at intervals consistent with the importance, complexity, and quantity of the item.

Audit findings shall be documented in a formal audit report and transmitted to the project leader and group supervisor (for project audits), the cognizant section manager (for generic system audits), or to the supplier.

If deficiencies have been found, the recipient of the audit report shall be required to take the necessary corrective action and report the action taken (or scheduled) to QA within ten working days. Quality Assurance shall follow up to verify the committed corrective action has been taken and is effective. =

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18.0 i

RADIOACTIVE MATERIAL PACKAGES Da te NOV., 1987 Supplementing the formal audits is a program of informal surveillance conducted by Quality Assurance during the course of a project.

The Quality Assurance Adminis-tra tor shall monitor the activities on a' day-to-day basis to assure the project is being conducted in accordance with the QA Plan. Any deficiencies requiring formal corrective action shall be documented on a Corrective Action Report and resolved in accordance with Section 16.0 of this manual.

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