qa program for type b radioactive matl sealed source

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Attechment 1-

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QUALITY ASSURANCE PROGRAM

FOR TYPE B RADIOACTIVE MATERI AL

SEALED SOURCE

TRANSPORT PACKAGES

SCHLUMBERGER WELL SERVICES

SCHLUMBERGER OFFSHORE SERVICES

5000 GULF FREEWAY, BOX 2175

HOUSTON, TEXAS 77001

ATTENTION:~

C. E. RACSTER

CHAIRMAN

RADI ATION SAFETY COhMITTEE

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DATE W e f / r 7 (*

APPROVAL

h G- k] R.~R. p OURD

PRESIDENT, SCHLUMBERGER WELL SERVICES

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I. . ORG ANIZATION1. Responsibility 1

2. QA/QC Functions 1

(a) _ Engineering 1

(b) Material - 1

(c) Operations 1

(d) Safety 23. Organizational Chart 24. Job Function 2

(a) The President 2(b) VP of Engineering 2

(c) VP of Material 2(d) VP Operations 2

(e) Radiation Safety Officer 2-

(f) Director of Product Systems 2(g) Department Herd of Engineering Physics 2(h) Product Quality Manager 2(i) Manager of Planning and Control 3(j) Manager of Manufacturing Engineering 3

(k) Quality Assurance Manager 3(1) Manager of Purchasing 3

5. Authority 36. Work Stoppage 3

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II. QU ALITY ASSUR ANCE PROGRAM1. Adequacy 32. QA Manual Distribution 33. Mandatory Requirements 34. Safety 35. Resolution of Disputes 46. Training Program 47. Quality Related Measurements 4

III. DESIGN CONTROL1. Design Planning 42. Regulatory Requirements 43. Design Review 44. Design Verification 45. Independent Design Review 4

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6. Quality Standards 57. Change Review 5

8. Re:;ponsibility Control 5

IV. PRODUCRE\f ENT DOCUMENT CONTROL1. Procedures 52. Applicable Code 63. Design Basis Technical Requirements 6

4. Documentation 6

5. Records 66. Agency's Rights 67. Change & Revisions 6

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. V. INSTRUCTIONS, PROCEDURES, AND DRAWINGS1. Prescribed Activities 62. Established Provisions 63. QA Reviews 6

VL DOCUMENT CONTROL1. Procedural Control 62. Changes 63. Implementation 6^

4. Availability 75. Master List 7

VIL CONTROL OF PURCHASED M ATERIALS, PARTS AND COMPONENTS1. Personnel Quahfications 72. Evaluation Bash 7

(1) NRC Approval 7(2) Review 7(3) Survey 7

3. Documentation 71

: 4. Surveillance 75. Furnished Records 7

(1) Identification 7i

- (2) Nonconformance 7| 6. Receiving Inspection 7

(1) Identification 7(2) Inspection Instructions 7(3) Inspection Records - 8(4) Inspection Status 8

VIII. IDENTIFIC ATION AND CONTROL OF M ATERIALS, PARTS & COMPONENTS1. Procedures 8

; 2. Identification 8'

3. Traceability 8; 4. Location of Identification 8

5. Identification Verification 8

IX. CONTROL OF SPECIAL PROCESSES1. Procedural Control 82. Process Qualification 83. Records 8

X. INSPECTION1. Con formance 92. Independence 93. Qualifications 94. Modifications, Repairs, & Replacements 95. Inspection Hold Points 9,

XL TEST CONTROL1. Test Program 92. Modifications, Repairs, & Replacements 93. Documentation 9

XII. CONTROL OF MEASURING AND TEST EOUIPMENT1. Calibration 102. Test Equipment Traceability 103. Validity of Inspection 104. Standard Traceability 10

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XIII. - HANDLING, STORAGE, AND SHIPPING1. Special Requirements 102.- NRC Conditions Satisfied 103. Shipping Papers 104. Transportation of the Package 10

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XIV. INSPECTION TEST AND OPERATING STATUSa1. Identi'.1 cation 11 <

2. Application 113. Bypassing 114. Status 11

XV. NONCONFORMING MATERIAL, PARTS, OR COMPONENTS1. Procedural Control 112. Disposition Approval 113. Segregation 11 -

4. Rework or Repair of Materials 11

XVI. CORRECTIVE ACTION1. Evaluation of Adverse Conditions 122. Corrective Action 123. Follow up 12

XVII. QU ALITY ASSURANCE RECORDS1. Record Maintenance 122. Procedures 123. Record Identification & Retrieval 124. Record List 125. Record Retention 126. Applicable Records 12

(1) Description 12(2) Evidence of Completion 12(3) Date & Results 12(4) Adverse Conditions 12(5) Recorder Identification 12(6) Evidence of Acceptability 12

XVIII. . AUDITS,

1. Procedures 132. Results 133. Re-Audits 134. Corrective Action 135. Frequency 13

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LEGEND

Q&RI Quality and Reliability Instructions ManualRS&C Radiation Sources and Controls ManualWSM Workmanship Standards ManualMat. Proc. Material Procedures ManualPDP Product Development PlanRad. Sfty. Com. Radiation Safety CommitteeSES Schlumberger Engi .aering StandardsFld. Op. Mn. Field Operations ManualSV'; Maint. Mn. SWS Maintenance ManualTO Purchase Order ModificationFD Program DevelopmentRPE Responsibility of Product EngineerQVM " Qualification of Vendor" MemorandumVPT Vice President - Techniques, Organizational Manual

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QUALITY ASSURANCE ITOGRAM |FOR TYPE B RADIOACTIVE MATERIAL !

SEALED SOURCETRANSPORT PACKAGES

INTRODUCTION

1. PURPOSE

This SWS Quality Assurance Program is promulgated to comply with therequirements of Section 71.51, 10 CFR Part 71 Appendix E, " Packaging ofRadioactive Material for Transport and Transportation of RadioactiveMaterial Under Certain Conditions" of the United States Nuclear RegulatoryCommission.

2. SCOPE

This SWS Quality Assurance Program, as required by 10 CFR Part 71 Appen-dix E, applies to the design, purchasing, fabrication, assembly, testing, use,repair, handling, shipping, sorting, cleaning, inspection, modifying, andmaintenance of the radioactive transport package.

L ORGANIZATION

1. The responsibility for the overall corporate Quality Assurance Pro-gram rests with the President of SWS, who established this progr:m,to assure a Quality Product, and to comply with applicable FederalRegulations.

2. The SWS quality assurance program is divided into four broad areas ofresponsibilty as follows: .

a. EngineeringAll design and engineering test data are generated by SWSEngineering Physics Department. Independent design reviewand revision level control are performed by SWS Product Engi-neering Department.

b. MaterialThe fabrication and testing of shipping packages are under thecontrol of the Material Department, who procures them fromvendors with NRC approved quality assurance programs.These vendors construct and test the package in accordancewith Product Engineering's engineering documents.

c. OperationsThe Operations Department is recponsible for proper usage,i.e., shipping, handling, and maintenance.

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d. SafetyThe Radiation Safety Committee is chaired by the corporateRadiation Safety Officer, who coordinates the overall corpo-rate program.

3. A current organintional chart is included with this document,attachment #1.

4. Corporate Responsib'lities relative to the Quality Assurance Pro-gram:

The President is responsible for the overall corporate Qualitya.Assurance Program, which is established to assure a qualityproduct and to comply with the applicable Federal regulations.

b. VP of Engineering - It is the responsiblity of Engineering toproduce shipping package designs which meet the objective ofthe corporation and fulfil requirements set forth by the NRCand DOT. When the design criteria is satisfied, the ProductionFile is released, and the announcement is signed by the VP ofEngineering.

VP of Material - It is the responsibility of the VP of Materialc.

to assure that all products are manufactured and/or procuredin compliance to the Production file as promulated by theEngineering Department.

d VP Operations - It is the responsibility cf the VP of Operationsto assure that the packages are used, maintained, and repairedto maintain compliance with the regulatioas of NRC and DOT.

Radiation Safety Officer -It is the responsibility of the Radia-e.tion Safety Officer to audit and review the activities of thevarious departments, to assure that the Quality AssuranceProgram is operating to assure a quality product, and to com-ply with the applicable federal regulations.

f. Director of Product Systems - It is the responsibility of theDirector of Product Systems to assure that independent designevaluations relative to the Product Development Plan and thiscriteria are implemented.

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g. Department Head of Engineering Physics - It is theresponsibility of the Department Head of Engineering Physicsto assure that the design responsibility relative to the ProductDevelopment Plan and this criteria are implemented.

h. Product Ouality Manager - It is the responsibility of the Pro-duct Quality Manager to assure that follow-up correctiveaction, initial acceptance, and package loading is performed

| according to SWS procedures, as represented by this! acceptance criteria.

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1. Manager of Planning & Control -It is the responsibility of the'

Manager of Planning and Control to assure that the MaterialDepartment orders, stores, and ships the transport packages

: according to the SWS procedures, as represented by this accep-tance criteria.,

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' j. Manager of Manufacturing Engineering -It is the responsibilityof the Manager of Manufacturing Engineering to assure thaty

the -Material Department participates in Production FileReview, that process instructions are available, that transport .,

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package purchasing documentation represents current design,and that suppliers are capable of complying with applicable

i SWS procedures, as represented by the criteria of thisi document.

t k. Quality Assurance Manager - It is the responsibility of the; Quality Assurance Manager to assure that the Quality and

Reliability instructions, and the workmanship standards; relative to this document's criteria are being implemented.

1. Manager of Purchasing -It is the responsibility of the Managerof Purchasing to assure that all transport packages are pur-

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chased from suppliers who have NRC approved Quality Assur-ance Programs, and that all pertinent documentation is re-

| ceived, retained, and maintained according to SWS procedures,i as represented by the criteria of this document.4

5. The duties and qualifications of the individual who retains overall,

! authority and responsibility for the SWS QA program are described in! *

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!. 6. Each of the personnel noted in I.4 and H.4 have the responsiblity and; authority, by the President's approval of this document, to stop

unsatisfactory work and control further processing, delivery, ort

j installations of nonconforming material.

H. QUALITY ASSURANCE PROGRAM:

1. The Chairman of the Radiation Safety Committee regularly assessesthe scope, status, implementation, and effectiveness of the overallcorporate QA program to assure that the program is adequate and4

: complies with 10 CFR Part 71 Appendix E.

! 2. The Material Department's Quality Assurance Manual is distributed,and revisions thereto are controlled by the Manager of Quality Assur-,

ance._

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3. The Chairman of the Radiation Safety Committee, as a part of H.1,

above, communicates to all responsible organizations and individuals.that quality policies, .QA manuals, and procedures are mandatory

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requirements which must be implemented and enforced.'1

4. The Ouality Assurance Program controls the pertinent components ofeach safety related system through the Radiation Safety Committee

: audits of the: PDP, SES, Material Procedures, Q&RI, WSM, RS&C,'

Field Operations Manual, SWS Maintenance Manual, etc..

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5. The Chairman of the Radiation Safety Committee has the responsi-bility and authority to resolve disputes involving quality, etsing froma difference of opinion between QA personnel and other apartments(Engineering, Procurement, Manufacturing, Operations, etc.) person-nel.

6. Indoctrinations and training programs within Quality Assuranceencompasses features which assure that persons receive instructionregarding the purpose, scope and implementation of the QA manuals,skill, instruction, and knowledge of procedures associated with theactivity being performed.

7. The Material Department's equipment necessary to accomplish speci-fied quality-related measurements is maintained and applied underenvironmental conditions suitable for that equipment. In addition,prerequisites for the inspection and test are satisfied prior to thatactivity.

III. DESIGN CONTROL

1. It is the responsibility of the Engineering group to produce equipmentdesigns which meet predetermined objectives. This is accomplishedthrough a formal procedure entitled " Product Development Plan."

2. Engineering Physics makes calculat ms, te sts, literature surveys,first drawings, models, and other activities in pursuit of the classicaldesign function. This includes attention to the applicable codes,industry practices, and regulatory requirements.

3. Near the conclusion of the design phase of development, an initialdesign review is held. The review is attended by representatives ofProduct Engineering, Manufacturing Engineering, and Operations. Asa part of this phase, a design prototype has been constructed' andtested.

4. Product Engineering receives drawings from Engineering Physics. Astudy is conducted to determine suitability of parts, materials, andconstruction techniques for quality and reliability, maintuance,economy, standards, and compliance to specifications. Correctionsare made, and a set of engineering drawings are created from whichengineering prototypes can be constructed. Included with the set ofdrawings are Engineering Specifications, Test and InspectionProcedures, Maintenance Instructions, etc. Next, a small number ofengineering prototypes (usually two) are built from the drawings.These prototypes are subjected to functional tests, environmentaltests, and, when applicable, field trials.

5. When it is proven that the prototypes are proper and the drawings areadequate, the second formal review occurs. The drawings and testresults are examined by Manufacturing Engineering, Operations,Engineering Physics & Production Engineering. The decision is thenmade to do additional engineering work, or to continue in the ProductDevelopment Plan. This review is called the Pilot Series LaunchMeeting.

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Pilot Series consists of a small number of initial production units(usually ten). During the Pilot Series, adequate time is scheduled byProduct Engineers to solve problems which usually occur during afirst production run.

Two units of the Pilot Series are subjected to functional and environ-mental tests by Product Engineering, and a report is written detailingresults of the tests.

When all is judged in order, a Production File Release is made.Documents which constitute the Production File are signed by theDrafting Technician, Desi;r. Engineer, and Product Engineer. Therelease announcement is signed by the Vice-President of Engineering.

6. The design function requirement noted in III.2 assures that classicalQuality Standards are specified in the design document. Any Productdeviation or change fro m the design document is controlled anddocumented by a formal system using the " Authorized EngineeringDeviation" with approval of a Product Engineer and the signature ofthe Product Engineering Supervisor. -

7. Design changes for all drawings are under the same revision control,starting with Pilot Series and continuing through the life of thedrawings. Any change to the drawing is mandatory cause to raise therevision level of that drawing. The change document is called the" Engineering Change Notice," which ' requires approval of both anengineer and an engineering supervisor. Records of historic drawings," Engineering Change Notices," and " Authorized Engineering Devia-tions," are preserved on archival microfilm.

8 Product Engineering is identified, by written and controlled Engi-neering documents, to be the authority and have the responsibility fordesign review and verification activities.

IV. PROCUREMENT DOCUMENT CONTROL

1. The procurement document process is initiated by Production Plan-ning, who forwards the SWS requirements to Purchasing by means of a"TR" card. Purchasing requests a production drawing summary of therequired items from Systems Engineering (Data Entry); upon receiptof the summary, a copy is forwarded to Engineering Records, whoprovides the drawings and specifications relative to the item to bepurchased.Purchasing attaches copies of the above file documentation to aQuotation Request and forwards it to the appropriate vendors forquotes. A copy of the file is also sent to Manufacturing Engineering,who reviews it and incorporates updates immediately prior to placingthe purchase order with a vendor.All records, certifications, and file updates are filed by Purchasingwith the purchase order for a minimum of two years.

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2. Procurement documents identify, where applicable, the 10 CFR Part71 requirements which require compliance and must be described inthe supplier's QA program.

3. Procurement documents contain or reference the design basic tech- '

nical requirements including the applicable regulatory requirementsnecessary to efficiently manufacture a quality product.

4. Procurement documents identify the documentation to be prepared,maintained and submitted to the purchaser for review and approval.

5. Procurement documents identify those records to be retained, con-trolled, and maintained by the supplier, and then delivered to thepurchaser prior to use or installation of the hardware.

6. Procurement documents contain the procuring agency's right toS access to supplier's facilities and records for source inspection and

audit.

7. Changes and revisions to procurement documents are subject to atleast the same review and approval as the original documents.

V. INSTRUCTIONS, PROCEDURES, AND DRAWINGS

1. The " Product Development Plan," " Material Department Procedures,"and " Quality and Reliability Instructions" assure that activities af-fecting quality are prescribed and accomplished in accordance withdocumented instructions, procedures, or drawings.

2. The " Product Development Plan" clearly delineates the sequence ofactions to be accomplished in the preparation, review, approval, andcontrol of instructions procedures and drawings.

3. The QA organization, as a function of product acceptance, reviewsand concurs with inspection plans; test, calibration, and special pro-cess procedures; drawings and specifications; and changes thereto, oracceptable alternatives.

VI. DOCUMENT CONT'lOL

1. The " Product Development Plan" administered by ProductEngineering assures that the review, approval, and issue of documentsand changes thereto, prior to release, are procedurally controlled toasure that they are adequate and that quality requirements arestated.

2, The " Engineering Standards" administered by Product Engineeringassures that changes to documents are reviewed and approved by thesame organizations that performed the original review and approval.

3. The " Engineering Standards" administered by Product Engineeringassures that approved changes are included in instructions,procedures, drawings, and other documents simultanously with theimplementation of the change.

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4. The Material Department Procedures assure that documents areavailable at the location where the activity will be performed prior tocommencing the work.

5. The " Engineering Standards" administered by Product Engineeringassures that a master list, or equivalent, is estabtished to identify thecurrent revision number of instructions, procedures, specifications,drawings, and procurement documents.

VII. CONTROL OF PURCHASED MATERIALS, PARTS, AND COMPONENTS

1. The Ouality Assurance Procedures provide for qualified personnel toevaluate the suppliers capability to provide acceptable quality serviceand procedures.

2. The evaluation of radioactive transport package suppliers is based on(1) as a minimum. . . ems (2) and (3) are also performed on vendorsintended to produce significant parts.

(1) The supplier having an NRC approved Quality AssuranceProgram.

(2) A review of previous records and performanct of suppliers whohave provided similar articles of the type being procured.

(3) A survey of the supplier's facilities and OA ,rogram to deter-7

mine his capability to supply a product which meets the design,manuf acturing, and quality requirements.

3. The letters documenting the results of the supplier evaluations arefiled with the Radiation Safety Committee.

4. Surveillance, if required, of suppliers during fabrication, inspection,testing, and shipment of materials, equipment, and components isplanned and performed in accordance with written procedures toassure conformance to the purchase order requirements.

5. The radioactive transport package supplier furnishes the followingrecords as a minimum to the purchaser:

(1) Documentation that identifies the purchased material orequipment, and the specific procurement requirements (e.g.,codes, standards, and specifications) met by the items.

(2) Documentation that identifies any procurement requirements'

which have not been met, together with a description of thosenonconformance dispositioned " accept as is" or " repair."

6. Receiving Inspection of the supplier-furnished material, equipmentand services is performed to assure:

(1) The material, component, or equipment is properly identifiedand corresponds with the identification on receiving documen-tation.

(2) Material, components, equipments, and acceptance records areinspected and judged acceptable in accordance with predeter-mined inspection instructions, prior to installation or use.

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(3) Inspection records or certificates of conformance attesting tothe acceptance of material and components are available priorto installation or use.

(4) Items accepted and released for use are identified as to theirinspection status prior to forwarding tuem to a controlledstorage area or releasing them for further work.

VIIL IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, ANDCOMPONENTS

All transport packages are procured solely from vendors who have NRCapproved quality assurance programs; thus, they comply with 10 CFR Part71 Appendix E. Therefore, t'ne SWS transport package is manufactured ac-cording to all the requirements outlined under this section:

1. Procedures are established to identify and control materials, parts,and components, including partially fabricated sub-assemblies.

2. Identification and control procedures assure that identification ismaintained either on the item being produced or on records traceableto the item to preclude use of incorrect or defective items.

3. Identification of materials and parts important to the function ofsafety-related systems and components can be traced to the appro-priate docum entation, such as drawings; specifications; purchaseorders; manufacturing and inspection documents; deviation reports;and physical and chemical mill test reports.

4. The location and the met).od of identification of the product does notaffect the fit, function, or quality of the item being identified.

5. The accuracy of identification of materials, parts, and components isverifled and documented prior to release for fabrication, assembling,and installation.

IX. CONTROL OF SPECIAL PROCESSES

All transport packages are procured solely from vendors who have NRCapproved quality assurance programs; thus, they comply with 10 CFR Part71 Appendix E. Therefore, the SWS transport package is manufactured ac-cording to all the requirements outlined under this section:

1. Special processes, such as welding, heat treating, nondestsctivetesting, and cleaning are procedurally controlled.

2. Procedures, equipment, and personnel connected with special pro-cesses are qualified in accordance with applicable codes, standards,and specifications.

3. Qualification records of procedures, equipment, and personnel asso-ciated with special processes are established, filed, and kept current.

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X. - INSPECTION

All transport packages are procured solely from vendors who have NRCapproved quality assurance programs; thus, they comply with 10 CFR Part71 Appendix E. Therefore, the SWS transport package is manuf actured ac-cording to all the requirements outlined under this section:

SWS . also maintains a broad independent Product Development Plan,Engineering Standards and Quality Assurance Program which provides forvendor evaluations and internal material and document control as follows:,

1. The SWS Quality Assurance Group has established and implemented a; documented program with written and controlled procedures for an

inspection program which verifies conformance of quality affectingactivities.

2. The inspection personnel are independent from the individuals per-forming the activity being inspected.

3. The inspectors are qualified in accordance with applicable standardsand company training programs; and their qualifications and certifi-;

cation are kept current.

4. Modifications, repairs, and replacements performed by the MaterialDepartment are inspected in accordance with the original design andinspection requirement.

5. The vendor is notified by Purchasing of the requirement to assure>

that provisions are established that identify mandatory inspectionhold points for witness by an inspector.

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XL TEST CONTROL

| All transport packages are procured solely from vendors who have NRC! approved quality assurance programs; thus, they comply with 10 CFR Part

71 Appendix E. Therefore, the SWS transport package is manufactured ac-cording to all the requirements outlined under this section:

SWS also maintains a broad independent Product Development Plan,i Engineering Standards and Quality Assurance Program which provides for

vendor evaluation and internal material and document control as follows:

1. A test program to demonstrate that the item or component willperform satisfactorily in service is established, documented, and,

accomplished in accordance with written controlled procedures.

2. Modifications, repairs, and replacements performed by the Material,

Department are tested in accordance with the original design andi

testing requirements.

3. Test results are documented, evaluated, and their acceptabilitydetermined by a qualified, responsible individual or group.

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XH. CONTROL OF MEASURING AND TEST EQUIPMENT

1. Manufacturing measuring and tes+. . Instruments .are calibrated atspecified intervals based on the required accuracy, purpose, degree ofusage, stability characteristics, and other conditions affecting themeasurement.

2. Manufacturing measuring and test equipment is identified and trace-able to the calibration test data.

3. Measures are taken to determine the validity of previous inspectionsperformed when measuring and test equipment is found to be out ofcalibration.

4. Reference and transfer standards are traceable to nationally recog-nized standards; or, where national standards do not exist, provisionsare established to document the basis for calibration.

XIII. HANDLING, STORAGE, AND SHIPPING

All transport packages are procured solely from vendors who have NRCapproved quality assurance programs; thus, they comply with 10 CFR Part71 Appendix E. Therefore, the SWS transport package is manufactured andshipped according to all the requirements outlined under this section.

SWS also maintains a broad independent Product Development Plan,,

Engineering Standards and Quality Assurance Program which provides for4

vendor evaluations and internal material and document control as follows:1

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1. Special handling, preservation, storage, cleaning, packaging, andi shipping requirements are estalished and accomplished by qualified; individuals in accordance with predetermined work and inspection*

instruction.

2. All conditions (operations, tests, inspections, specifications, etc.) ofthe NRC package approval and the U. S. Department of Transporta-tion shipping requirements are satisfied by the vendor, or by SWS '

prior to shipment.,

3. All necessary shipping papers are prepared as required.:

4. Departure, arrival time, and destinations of a package will be estab-4

lished and monitored by the vendor, or by SWS, to a degree consistantwith the safe transportation of the package.

XIV. INSPECTION, TEST AND OPERATING STATUS

All transport packages are procured solely from vendors who have NRCapproved quality assurance programs; thus, they comply with 10 CFR Part71 Appendix E. Therefore, the SWS transport package is manufacturedaccording to all the requirements outlined under this section.

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SWS also maintains a broad independent Product Development Plan,Engineering Standards and Quality Assurance Program which provides forvendor evaluations and internal material and document control as follows:

1. Identification of the inspection, test, and operating status of pack-ages and components is known by affected organizations.

2. The application and removal of inspection and welding stamps, andstatus indicators, such as tags, markings, labels, and stamps, areprocedurally controlled.

3. SWS does not knowingly bypass any required inspections, tests, orcritical operations.

4. The status of nonconforming, inoperative, or malfunctioning packagesor components is identified to prevent inadvertent use.

XV. NONCONFCh*ING MATERIAL, PARTS, OR COMPONENTS


SWS also maintains a broad independent Product Development Plan,"

Engineering Standards and Quality Assurance Program which provides forvendor evaluations and internal material and document control as follows:

1. The identification, documentation, segregation, review disposition,and notification to affected organizations of nonconforming mater-ials, parts, components, or services, are procedurally controlled.

2. Documentation identifies the nonconforming item, describes thenonconformance, the disposition of the nonconformance, the inspec-tion requirements, and includes signature approval of the dispostion.

3. Nonconforming items are segregated from acceptable items andidentified as discrepant until properly dispositioned.

4. The acceptability of rework or repair of materials, parts, compo-nents, and systems is verified by reinspecting and retesting the itemas originally inspected and tested; or by a method which is at leastequal to the original inspection and testing method.

XVI. CORRECTIVE ACTION


SWS also maintains a broad independent Product Development Plan,Engineering Standards and Quality Assurance Program which provides forvendor evaluations and internal material and document control as follows:

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. 1. The evaluation of conditions adverse to quality (such as nonconfor- ~l

mances, failures, malfunctions, deficiencies, deviations, and defec-tive material and equipment) is conducted to determine the need for

,corrective action in accordance with established procedures.

2. Corrective action is initiated following the determination of a condi-tion adverse to quality to preclude recurrence.

3. Follow up reviews are conducted to verify proper implementation of.

corrective actions and to close out the corrective action documen-tation. ;,

XVH. QUALITY ASSURANCE RECORDS;


$ SWS also maintains a broad independent Product Development Plan andj Quality Assurance Program which provides for vendor evaluations and inter-' nal material and document control as follows:

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1. Sufficient records are maintalned to provide documentary evidence ofj the quality and safety of items, and the activities affecting qualityi and safety.i' 2. QA records include operating logs; results of reviews, inspections,1 tests, audits, and material analyses; procedures and equipment; and

other documentation,. such as drawings, specifications, procurementdocuments, calibration procedures, and reports; and corrective actionreports.

I3. Records are identifiable and retrievable.

4. A list of the required records and their storage locations will bemaintained by the chairman of the Radiation Safety Committee.=3

' 5. Design related records are. maintained for the life of the shipping"

package, and the vendor is notified by Purchasing that all other re-,

cords are to be maintained for a minimum of two years.

6. Where applicable, the inspection and test records contain the fol-,

lowing:(1) A description of the type of observations.,

(2) Evidence of completing and verifying a manufacturing, inspec-'

tion, or test operation.(3) The date and results of the inspection or test.(4) Information related to conditions adverse to quality. |

(5) Inspector or data recorder identification.(6) Evidence as to the acceptability of the results.,

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XVIII. AUDITS

1. The Radiation Safety Committee will perform audits of the SWS,

Quality Assurance Program using the 10 CFR Part 71 Appendix Eacceptance criteria.

2. The results of audits and their corresponding corrective action willbecome a part of the permanent records of the Radiation SafetyCommittee.The Radiation Safety Committee will review the audit results withthe VP of each department audited.

3. The VP of each department will take the necessary action to correctthe deficiencies revealed by the audit.

4. Deficient areas will be reaudited on a timely basis, not to exceedthree months, to verify implementation of corrective actions whichminimize recurrence of deficiencies.

5. The Chairman of the Radiation Safety Committee is responsible foran ongoing corporate QA program audit. A yearly audit of eachdepartment is considered a minimum.

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Attochmeat 2.*PRESIDENT

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CHAIRMANRADIATION SAFETY

COhtiITTEE

Develops Safety ProceduresAudit Effectiveness

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Overall coordination ofQuality Assurance Program

VP ENGINEERING VP MATERIAL VP OPERATIONS

Procurement of packages from outside vendorswith NRC approved Quality Assurance Programs. Implement Procedures User

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ENGINEERING PRODUCT PLANNING PRODUCT MANUFACRTRINGt)HYSICS SYSTEMS & CONTROL QUALITY ENGINEERING

PackageDesign

Requirements

PRODUCT PURCHASING QUALITYENGINEERING ASSURANCE

NG Design Review Approved Vendors

(dA Working Dwgs. Pick Instrument Products, Inc.

Test Specs. Monsanto Research Corp.O Nuclear Sources &-Services, Inc.Ganna Industries

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