ML20133F931
| ML20133F931 | |
| Person / Time | |
|---|---|
| Site: | 07100230 |
| Issue date: | 08/31/1985 |
| From: | Bennett R, John Kramer, Roberts G BABCOCK & WILCOX CO. |
| To: | |
| Shared Package | |
| ML20133F926 | List: |
| References | |
| NUDOCS 8510150039 | |
| Download: ML20133F931 (36) | |
Text
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s QUALITY ASSURANCE PROGRAM POR RADIOACTIVE MATERIAL PACKAGES NO. 0230, REVISION 3 AUGUST, 1985 ISSUE NUMBER ASSIGNED TO BABCOCK & WILCOX COMPANY RESEARCH & DEVEIOPMENT DIVISION LYNCHBURG RESEARCH CENTER 1
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PREPARED BY:
- %W J. E. KRAMER, M ADMINISTRATOR REVIEWED BY:
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R. L. BENNETT, MANAGER, SAFETY & LICENSING APPROVED BY:
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f G. W. ROBc.his, @ MANAGER 85I0150039 BDUYUV PDR ADOCK 07100230 C
s LYNCHBURG RESEARCH CENTER QUALITY ASSURANCE PROGRAM FOR RADIOACTIVE MATERIAL PACKAGES Section No. i August, 1985 TABLE OF CONTENTS i
Table of Contents 11 Revisions lii - Introduction 1.0 Organization 2.0 Quality Assurance Program 3.0 - Design Control 4.0 - Procurement Document Control 5.0 - Instructions, Procedures, and Drawings 6.0 - Document Control 7.0 - Control of Purchased Material, Equipment, and Services 8.0 Identification and control of Materials, Parts, and Components 9.0 - Control of Special Processes 10.0 - Inspection 11.0 Test Control 12.0 Control of Measuring and Test Equipment 13.0 - Handling, Storage, and Shipping 14.0 - Inspection, Test, and Operating Status 15.0 Nonconforming Material, Parts, or Components 16.0 Corrective Action 17.0 - Quality Assurance Records 18.0 Audits l
4 LYNCHBURG RESEARCH CENTER QUALITY ASSURANCE PROGRAM FOR RADIOACTIVE MATERIAL PACKAGES Section No.
ii August, 1985 REVISIONS DATE DESCRIPTION APPROVED 12/78 Original Release 4
1/80 Revision 1 - revised to include NRC's coments of 11/1/79.
5/80 Revision 2 - Added index to Section 2.0 per NRC's coments of 3/14/80.
8/85 Revision 3 - Updated implementing procedure listing.
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Revised to reflect changes in reporting responsibi-ties of Quality Assurance Administrator, SNM Accounta-bility specialist, and Health Physics.
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LYNCHBURG RESEARCH CENTER i
QUALITY ASSURANCE PROGRAM FOR l
RADIOACTIVE MATERIAL PACKAGES l
Section No. iii 4
August, 1985 1
l INTRODUCTION i
j This manual describes the Quality Assurance (@) Program for shipping packages which transport certain quantities of radioactive material that is currently in effect at the Lynchburg Research center (LRC), Research & Development Division (R&DD) of the Babcock & Wilcox Company (B&W). he @ Program imposes standards of quality through the development of policies, procedures and instructions, and the implementation of effective plans and disciplines.
h is manual meets the requirements of 10 CFR Part 71, Appendix E, " Quality As-surance criteria for shipping Packages for Radioactive Material". It should be I
noted that for any specific package, not all of the sections of this manual will necessarily be imposed. % e @ Program, however, requires the development of a formal S Plan which shall specify the applicable sections of this manual.
The Quality Assurance Administrator has the responsibility and authority for the I
administration and assurance of conformance with the requirements of the program l
described in this manual. He has the authority and responsibility to require corrective action for shipping packages which do not conform to the objectives i
t and policies outlined in this manual. Compliance with the intent of these objectives is also required of suppliers to LRC through requirements transmitted in procurement documents.
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LYNCHBURG RESEARCH CENTER QUALITY ASSURANCE PROGRAM FOR RADIQACTIVE MATERIAL PACKAGES Section No. 1.0 August, 1985 ORGANIZATION Implementation and maintenance of the OA Program for manufacture, use, and re-pair of radioactive material shipping containers is the responsibility of R&DD management. Containers for shipment of NRC licensed material may be designed and constructed by an R&DD approved contractor or designed, constructed, pur-chased, repaired or used by the LRC. However, responsibility for quality as-Curance resides with R&DD management.
The Lynchburg Research Center is organized as shown in the organization chart (Figure 1). Written administrative procedures delineate the functions and re-sponsibilities of the organizations within the Research & Development Division cnd the LRC.
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 i
requirements are accomplished by individuals or groups who do not have direct rcsponsibility for performing the work being verified. Trained, qualified per-sonnel within R&DD shall determine if functions delegated to suppliers are being recomplished.
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LYNCHBURG RESEARCH CENTER QUALITY ASSURANCE PROGRAM FOR RADIOACTIVE MATERIAL PACKAGES Section No. 1.0 August, 1985 DIRECTOR 1.
l MANAGER MANAGER QUALITY SAFETY AND ASSURANCE LICENSING
-l QUALITY ASSURANCE SNM HEALTH ADMINISTRATOR ACCOUNTABILITY PHYSICS SPECIALIST Figure 1.
The principal responsibilities and authorities of the LRC Quality Assurance Program for Shipping Packages are vested in the following positions at the LRC.
Quality Assurance Administrator The responsibility for implementing the Quality Assurance Program lies with the Quality Assurance Administrator. He reports to the Director through the I
Manager, Quality Assurance.
He. is separated from all other sections thus assuring independence in carrying out the functions of inspecting, auditing, and i
i vstifying conformance to 10 CFR 71, Appendix E criteria. He is responsible for the implementation of the QA Program, including review and approval of vendor quality assurance programs. He has the authority to withhold from further i
processing or use the materials, parts, or components which do not meet the applicable requirements. The qualifications for QA Administrator include a BS degree or equivalent, or the ability to substitute equivalent experience; and a i
minimum of two years quality-related experience in industry.
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LYNCHBURG RESEARCH CENTER QUALITY ASSURANCE PROGRAM FOR RADIOACTIVE MATERIAL PACKAGES Section No. 1.0 August, 1985 SNM Accountability Specialist
'Ihe responsibility for selecting and ordering shipping containers lies with the SNM Accountability Specialist. He also completes required forms prior to ship-ment.
Health Physics Health Physics personnel are responsible for monitoring and verifying the nu-clear and radiological safety of the shipping packages. Typical duties include:
radiation surveys, labeling of shipping containers and vehicles, generation and retention of. Health-Safety documentation, and enforcement of health physics and nuclear safety standards.
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LYNCHBURG RESEARCH CENTER QUALITY ASSURANCE PROGRAM FOR RADIOACTIVE MATERIAL PACKAGES Section No. 2.0 August, 1985 QUALITY ASSURANCE PROGRAM The Lynchburg Research Center Quality Assurance Program for Shipping Packages documented in this manual is in accordance with corporate OA policies, goals, and objectives. fue QA Program regulates activities associated with the design, procurement, manufacture, production, testine, inspection, preservation, and handling of nuclear co.9ponents and services. Compliance with the requirements of this QA Program is mandatory for all LRC organizations and personnel.
Indoctrination and training programs require:
Instruction of organizations and personnel responsible for performing a.
quality related activities. Instruction includes the purpose, scope, and mandatory implementation of the quality related manuals, instruc-tions, and procedures.
b.
Personnel performing quality related activities be trained and quali--
fled in the principles and techniques of the activity being performed.
The scope, the objective, and the method of implementing the indoctri-c.
nation and training program be documented.
d.
Proficiency of personnel performing quality related activities te maintained by re-training, re-examining, and/or re-certifying.
S2fety-related structures, systems, and components controlled by the QA Program shall include, as a minimum, structural requirements to maintain container in-t;grity, radiatier. shielding, and neutron absorbents.
Controls shall be maintained over suppliers and consulting organizations to as-sure that 10 CFR Part 71, Appendix E is implemented.
Management reviews of the QA Program are conducted periodically to assess its scope, implementation, and effectiveness.
t INDEX CROSS-REFERENCING APPENDIX E CRITERIA WITH QA PROCEDURES CRITERIA QA PROCEDURES m
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Organization 0101-02 (R&D Division Functions & Responsibilities 2.
Quality Assurance Program 1702-01 (Quality Assurance Program for the R&D Division) 3 l
3.
Independent Tecnnical Reviews 1704-03 (Independent Technical Reviews) 4.
Procurement Document Control 1211-01 (Requisitions) 5.
Instructions, Procedures and 1706-01 (Technical Procedures)
Drawings 1706-02 (Drawing Preparation Procedure) t 1706-08 (Preparation of Calibration Procedures)
- o g 1709-05 (Route Sheets).
6g 1711-01 (Inspection Checklists) g"N
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Document Control 1702-02 (Preparation, Maintenance, & Control of the QA Manual)
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Control of Purchased 1216-02 (Shipping and Receiving)
Material, Equipment, 1708-01 (Supplier Control)
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and Services 8.
Identification and Control 1709-01 (Material Identification Tags)
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l of Materials, Parts, and 1715-01 (Inspection Acceptance Tags) j Components 1715-02 (Discrepancy Tags) j.
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Control of Special Processes 1706-01 (Technical Procedures) g, g "$
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CRITERIA QA PROCEDURES
- 10. Inspection 1711-01 (Inspection Checklist) 1711-02 (Inspection) 1715-01 (Inspection Acceptance Tag) 1715-02 (Discrepancy Tag)
- 11. Test Control 1712-01 (Test Control)
- 12. Control of lieasuring and 1713-01 (fieasuring Equipment Control and Calibration)
Test Equipment 1713-02 (Out-of-Calibration Report)
- 13. Handling, Storage and 1216-02 (Shipping and Receiving)
Shipping 1217-06 (Equipment Storage) p 1706-01 (Technical Procedures) 6 g"s@r*
1711-01 (Inspection Checklist)
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- 14. Inspection, Test, and 1413-03 (Equipment Operation tiotice)
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Operating Status 1413-05 (Do flot Operate Tags) 1715-01 (Inspection Acceptance Tags) 2 1715-02 (Discrepancy Tag)
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- 15. fionconforming liaterials, 1716-01 (Control of fionconforming Items) h@~O
-Parts or Components 9
- 16. Corrective Action 1717-01 (Corrective Action System) gH
- 17. Quality Assurance Records 1718-03 (Quality Assurance Records)
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LYNCHBURG RESEARCH CENTER QUALITY ASSURANCE PROGRAM FOR RADIOACTIVE MATERIAL PACKAGES Section No. 3.0 August, 1985 DESIGN CONTROL Design activities at the Lynchburg Research Center are conducted in accordance with administrative procedures which assure applicable quality standards and design features are translated into specifications, drawings, procedures, and instructions. 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 materials, and Eccessibility for in-service inspection, maintenance and repair. Designs are clso reviewed to assure (1) design characteristics can be controlled, inspected, and tested, and (2) inspection and test criteria are identified. Materials, parts, and equignent which are standard, commercial, or which have been previously approved for a different application are reviewed for suitability prior to selection. Measures are established for the selection of suitable materials, parts, equipment, and processes for safety-related structures, systems, and components including the use of valid industry standards and cpecifications.
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 t:st of a prototype unit under adverse operating conditions shall be used.
Design interface controls include the review, approval, release, distribution and revision of documents with participating design organizations. Design and specification changes are subject to the same design controls and approvals ap-plicable to the original design. Errors or deficiencies in the design, includ-ing the design process, that could adversely affect safety-related structures, systems, and components are documented and handled in accordance with Section 16.0 of this manual.
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,I LYNCHBURG RESEAROI CENTER QUALITY ASSURANCE PROGRAM FOR RADIOACTIVE MATERIAL PACKAGES i
Section No. 4.0 a
i August, 1985 I
PROCUREMENT DOCUMENT CONTROL I
Quality Assurance shall review 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, quality assurance program requirements, provisions for extending applicable requirements to lower tier suppliers, requirements for ma-l terial certifications or certificates cf conformance, and other applicable 10 l
CFR Part 71, Appendix E requirements.
i Quality Assurance shall verify the proposed supplier has been evaluated and ap-proved according to the provisions of Section 7.0 of this manual and shall j
notify Purchasing if an approved supplier must be used for the purchase.
1 Procurement documents for spare or replacement parts of safety related struc-tures, systems, and components are subject to controls at least equivalent to those used for the original equipment.
1 Changes to purchase requisitions or purchase orders shall receive the same level of approval as the original document.
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LYNCHBURG RESEARCH CENTER QUALITY ASSURANCE PROGRAM FOR RADIOACTIVE MATERIAL PACKAGES i
l Section No. 5.0 August, 1985 I
INSTRUCTIONS, PROCEDURES, AND DRAWINGS i
Activities at the Lynchburg Research Center are directed by documented instruc-i tions, procedures, and drawings appropriate to the circumstances to which they i
are applied.
Fabrication Drawings are prepared by Design Services (or other appropriate or-ganizations) checked by Design Services for safety, functional and structural cdequacy, and dimensional accuracy for critical components. Drawings are re-viewed by responsible sections to verify design requirements. Revision level j
and approvals are applied to the drawings prior to release to the shop for fab-j rication. Revisions to drawings are subject to the same level of approval as original drawings prior to implementation of changes.
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If Design Services and Quality Assurance determine fabricatilon, assembly, or process control is required, the drawings shall contain a note stating that route sheets are required.
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Route Sheets shall reference the drawing and revision number to be used, in-dicate the sequence of operations to be followed, provide a place for recording data, reference technical procedures (including revision) to be used in perform-ing the operation, identify acceptance criteria (if not on the drawing or in the i
tschnical procedure), and provide for the initials of the person completing the operations. If an independent inspection function is to be employed, the route l
sheet shall provide for initials of the inspector evaluating the operation.
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LYNCHBURG RESEARCH CENTER QUALITY ASSURANCE PROGRAM FOR RADIOACTIVE MATERIAL PACKAGES Section No. 5.0 August, 1985 Inspection Checklists are used for verifying recording of physical char-acteristics consi,dered critical to the component. Checklists can be used in place of route sheets when the inspection is performed after the part has been completed with no in-process control of fabrication.
Administrative Procedures are used to implement policies and to direct the cctivities of one or more organizations. 'Ihey describe interface requirements cnd provide the detailed work instructions for recurring functions.
Technical Procedures are used to direct specific technical activities such as the performance of experiments or tests, calibration of equipment, error analy-sis, or special process control; (i.e., welding, nondestructive examination, ste). When used as test performance procedures, the technical procedures shall include provisions for assuring test prerequisites have been met (reference Sec-tion 11.0), there are provisions for recording data either on test data sheets or in test logs, and requirements for customer witnessing of the test are met.
When material control is required during the performance of a test or experi-ment, the test procedures shall direct the handling and identification of the controlled material.
The QA organization shall reviw and concur with technical procedures, inspec-tion plans, drawings and specifications, and changes thereto.
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LYNCHBURG RESEARCH CENTER QUALITY ASSURANCE PROGRAM FOR RADIQACTIVE MATERIAL PACKAGES Section No. 6.0 August, 1985 DOCUMENT C0tfIROL i
I he documents affecting quality controlled by the provisions of this section are:
Administrative Procedures Drawings Inspection Checklists Quality Assurance Program Manual Quality Assurance Plans Route Sheets Technical Procedures Administrative Procedures are prepared and revised by personnel reporting di-rsctly to either the Director of the LRC or the Vice-President, R&DD. We resolution of conflicting requirements shall be the responsibility of the Director or the Vice-President. %e editing, arranging, and issuing of procedures to authorized personnel is the responsibility of the Administrative Procedure Manual Coordinator of the R&D Division. We Manual Coordinator is also responsible for obtaining approval signatures from the Vice-President, Director, and the Managers on the master file copy and for retention of historical file copies of the manual.
,4 Drawings are prepared by appropriate organizations and controlled by Design Services. Revision level and approvals are reflected on the drawings and on status cards maintained by the engineering group. Original releases and re-visions must be approved by the design engineer and the responsible section per-sonnel. Design Services maintains a distribution list and assures the latest h 4
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LYNCHBURG RESEARCH CENTER QUALITY ASSURANCE PROGRAM FOR RADIOACTIVE MATERIAL PACKAGES Section No. 6.0 August, 1985 cpproved revision applicable to a job is used. Drawing masters are retained as required by contract requirements or R&DD retention policy.
Inspection Checklists are prepared and revised by Design Services or the re-cponsible section and approved by the individual specifically responsible for the container.
The checklists are issued to the person performing the verifi-cation. Completed checklists are returned to the responsible section for inclusion in the project file.
Quality Assurance Program Manual The Quality Assurance Program description is prepared by Quality Assurance and cpproved by the Quality Assurance Manager. The Quality Assurance Administrator u.aintains the distribution lists and issues copies of the manual on a controlled cnd uncontrolled basis.
Controlled manuals have an issue number assigned to cach 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 maintained. Revisions of the manual are subject to the same control as the original release. The revision page shall be signed by the Quality Assurance Administrator to indicate necessary approvals have been r:ceived.
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 section maintains the distribution lists.
Revisions are subject to the same control as the originals.
LYNCHBURG RESEARCH CENTER QUALITY ASSURANCE PROGRAM EOR RADIOACTIVE MATERIAL PACKAGES Section No. 6.0 August, 1985 Route Sheets are prepared when fabrication, assembly, or process control is required. 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 content, revision, approvals, and identifying distribution. Quality Assurance shall provide the originator with a unique identification number.
Once the procedure has been approved, Quality Assurance shall obtain final release, reproduction and distribution of copies. Revisions require the same levels of approval as the original.
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QUALITY ASSURANCE PROGRAM EVR RADIQACTIVE MATERIAL PACKAGES Section No. 7.0 August, 1985 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES When required, pre-award audits and surveillance of suppliers during fabrication, inspection, testing, and shipment of materials, equipnent 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 instructions 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. Suppliers are periodically evaluated by audits, independent inspections, or tests 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 following criteria shall be used:
4 The supplier must have a previous and continuous record of supplying a.
acceptable items, processes, or services to the requirements of R&DD procurement documents. For purposes of meeting this criterion, R&DD may elect to use supplier quality history data obtained from other B&W
~ divisions provided the data is for similar items, processes, or ser-vices 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. l
i LYNCHBURG RESEARCH CENTER QUALITY ASSURANCE PROGRAM IVR I
RADIOACTIVE MATERIAL PACKAGES Section No. 7.0 August, 1985 For commercial or "off the shelf" items, a receiving inspection should c.
be performed to determine compliance with procurement document re-quirements.
L Approved Supplier List i
If a supplier has been evaluated and approved, Quality Assurance shall add the supplier's name to the R&DD Approved Supplier List. The list will be distributed to appropriate personnel at the LRC and to the Purchasing Depart-ment. Purchase 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 by R&DD is required, the audit shall 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.
Supplier audits for DCfr specification containers are not performed.
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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 j
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 verification of procurement requirements cannot be determined upon receipt.
R:ceiving Inspection R2ceiving inspection of the supplier furnished material, equipment, and services i
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LYNCHBURG RESEARCH CENTER QUALITY ASSURANCE PROGRAM FOR RADIOACTIVE MATERIAL PACKAGES Section No. 7.0 August, 1985 The material, component, or equipment is properly identified and a.
corresponds with the identification on receiving documents.
b.
Materials, components, equipnent, and acceptance records are inspected and judged acceptable in accordance with pre-determined inspection in-structions, prior to installation or use.
Inspection records or certificates of conformance attesting to the c.
tcceptance of materials, components, and equipment are available prior to installation or use.
d.
Items accepted and released are identified by inspection status prior to forwarding to a controlled storage area or releasing for installa-tion or fabrication.
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 ar-rival, items shall be segregated and not released for use until accepted by in--
spection. If specific procedures are required to perform the inspection, they chall be provided to the inspector prior to commencement of the receipt inspec-tion. A notation of special instructions and requirements shall be made on the purchase order.
Supplier Procedures Requirements for suppliers to submit specific procedures for R&DD review and ap-proval shall be included (as applicable) on the purchase order. When the proce-dures are received, they shall be routed to the project leader for review and tpproval. Supplier QA procedures shall be reviewed by Quality Assurance and the project leader. Supplier QA manuals shall be routed to QA for review, approval and retention. i
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LYNCHBURG RESEARCH CENTER QUALITY ASSURANCE PROGRAM FOR RADIOACTIVE MATERIAL PACKAGES Section No. 7.0 August, 1985 Records Suppliers shall furnish the following records:
Documentation identifying the purchased material or equipment and the a.
specific requirements (e.g., codes, standards, and specifications) met i
by the items.
b.
Documentation identifying procurement requirements which have not been met together 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 Pro-gram and shall be undertaken by a responsible QA representative.
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4 LYNCHBURG RESEARCH CENTER QUALITY ASSURANCE PROGRAM K)R RADIQACTIVE MATERIAL PACKAGES Section No. 8.0 August, 1985 CONTROL OF MATERIALS, PARTS & COMPONTNTS Material shall be controlled using a system of tags, route sheets, and technical procedures to assure accurate recording of traceability of material by part num-ber, lot number, serial number, or heat number.
Identification must be verified
&nd documented.
Identification requirements are determined during generation of 1
specifications and design drawings.
R&DD Administrative Procedures direct the use of a tagging system to be applied to all controlled materials. When route sheets or technical procedures are used, material identification shall be transferred to route sheets, test data
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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 reidentified to reflect their i
resulting condition. The location and the method of identification shall in no way affect the fit, function, or quality of the item be'ing identified.
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i LYNCHBURG RESEARCH CENTER QUALITY ASSURANCE PROGRAM FOR RADIOACTIVE MATERIAL PACKAGES Section No. 9.0 August, 1985 CONTROL OF SPECIAL PROCESSES Special processing techniques u' sed to support fabrication or performance of an experiment or test shall be documented in technical procedures with the requi-site 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 re-quired (such as for welding), appropriate qualification records shall be main-tained reflecting examination results, training records, and maintenance of pro-ficiency. In most areas, the performance of a special process (for example, NDE) is by laboratory personnel directly engaged in the research aspects of the process who are, by nature of their work, qualified well above standards imposed on production facilities. These qualifications are on file in the Personnel De-partment. When required in direct support of an experiment or test, appropriate process control records shall be maintained.
LYNCHBURG RESEARCH CENTER QUALITY ASSURANCE PROGRAM FOR RADICACTIVE MATERIAL PACKAGES l
Section No. 10.0 August, 1985 INSPECTION Inspections are performed on those activities affecting quality to assure con-formance with documented instructions, procedures, and drawings. The need for inspection is identified on the receiving copy of the purchase order, route sheets, technical procedures, and/or inspection checklists. Manc.atory inspec-tion hold points for witness by an inspector shall also be identified on these documents. Critical dimensions are identified on the drawings. Any modifica-tions, repairs, or replacements shall be inspected in accordance with the cri-ginal design and inspection requirements or acceptable alternatives. When di-rect inspection is not possible, indirect control shall be achieved by moniter-ing processing methods, 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.
LYNCHBURG RESEARCH CENTER QUALITY ASSURANCE PROGRAM FOR RADIOACTIVE MATERIAL PACKAGES Section No. 11.9 i
August, 1985 TEST C0tEROL Test control is provided by techtical procedures (Reference Section 5.0).
Responsibility for preparation of the test program and the test performance pro-cadure is assigned to the project leader who obtains the necessary approvals.
The revision and distribution control is described in Section 6.0 of this man-I ual. Each test procedure shall include provisions for ensuring test prereq-uisites have been met. Prerequisites include items such as calibrated instru-mentation, appropriate equipment, trained personnel, condition of test equipment and the item to be tested, suitable environmental conditions and provisions for data acquisition. Written test procedures shall incorporate the following:
The requirements and acceptance limits contained in applicable designs a.
and procurement documents, b.
Instructions for performing the test.
Mandatory inspection hold points for witness by owner, contractor, or c.
inspector.
d.
Acceptance and rejection criteria.
Tzst data and results shall be documented using test logs, data sheets, or a computer 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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LYNCHBURG RESEARCH CENTER QUALITY ASSURANCE PROGRAM FOR RADIOACTIVE MATERIAL PACKAGES Section No. 12.0 August, 1985 CONTROL OF MEASURING AND TEST EQUIPMENT A documented system is established and maintained to assure tools, gauges, instruments, inspection and measuring and test equipment used in activities affecting quality are of the proper range, type and accuracy to verify conform-ance to established 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 pro-cedures, and a recall system to assure equipment is calibrated within esta-blished intervals. The accuracy of calibrated equipment is assured by one of the following:
Traceability to standards maintained by the National Bureau of a.
Standards b.
Comparison to natural physical phenomenon The ratio type of self-calibration techniques c.
Items within this system are given a unique serial number for traceability to calibration test data.
Calibrations are recorded on a service log form showing the serial number of the item and the procedure to which it is calibrated.
A lchel is applied to the item to indicate the calibration status, including cali-bration due date.
The complete status of items under the calibration system is l
maintained. l
LYNCHBURG RESEARCH CENTER QUALITY ASSURANCE PROGRAM FOR RADIOACTIVE MATERIAL PACKAGES Section No. 12.0 August, 1985 If inspection and measuring and test equipment is found to be out of calibra-tion, an out-of-calibration report is issued by the Calibration Lab. An evalu-ction of the validity of previous inspection or test results and of the accepta-bility of items previously inspected or tested is made and documented. If in-spection and measuring or test equipment is consistently found to be out of calibration, it is repsired or replaced.
Calibration standards have an uncertainty (error) requirement of no more than one-fourth of the tolerance of the equipnent being calibrated. A greater un-certainty may be acceptable when limited by " state-of-the-art".
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LYNCHBURG RESEARCH CENTER QUALITY ASSURANCE PROGRAM FOR RADIOACTIVE MATERIAL PACKAGES Section No. 13.0 August, 1985 HANDLING, S'IORAGE, AND SHIPPING Special handling, storage, shipping, packaging, preservation, or cleaning in-structions required for containers are identified by the project leader. The project leader either issues a technical procedure detailing these requirements or coordinates with Design Services to have the requirements defined on drawings. The technical 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 l
tasks and the inspection (if necessary) of the activity.
Special handling and loading procedures for NRC and DOT approved containers are documented in the specification, certificate of Compliance, or referenced procedure. Completion of these requirements are assured by the project leader Gnd are documented.
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LYNCHBURG RESEARCH CENTER QUALITY ASSURANCE PROGRAM FOR RADIOACTIVE MATERIAL PACKAGES Section No. 14.0 August, 1985 INSPECTION, TEST, AND OPERATING STA'IUS If required by contract or work order involving material control, a system of markings, tags, route -sheets, inspection checklists, test data sheets, test logs, or inspection records are used to identify the inspection and test status.
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. By-passing of re-quired inspections, tests, and other critical operations is procedurally con-trolled 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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LYNCHBURG RESEARCH CENTER QUALITY ASSURANCE PROGRAM FOR RADIOACTIVE MATERIAL PACKAGES Section No. 15.0 August, 1985 l
l NONCONFORMING MATERIALS, PARTS OR COMPONENTS Nonconforming items shall be tagged with a red " discrepancy" tag, segregated whenever possible, and the nonconformance documented on a Corrective Action Re-port (CAR). 'Ihe CAR identifies the nonconforming item, describes the noncon-formance, the disposition of the nonconformance, the inspection requirements, and includes signature approval of the disposition.
l The project leader, shall review nonconformances to determine adverse effects to the test results, finished products or repairs. The project leader shall cpprove actions taken to correct the nonconformance or to "use-as-is".
Quality Assurance shall approve all Corrective Action Reports and, when the nonconfor-l mance is satisfactorily resolved, shall remove the " discrepancy" tag from the j
item.
j In instances requiring a " repair" or "use-as-is" decision, the project leader i
shall determine whether such a decision causes a deviation to customer require-ments or comitments made in the proposal or project technical plan. If a de-viation exists, the project leader must obtain approval from the customer before i
implementing the " repair" or "use-as-is" decision. Acceptability of rework or i
repair of materials, parts, components, systems, and structures is verified by reinspecting and retesting the item as originally inspected and tested, or by a i
method which is at least equal to the original inspection and testing method.
Inspection, testing, rework, and repair procedures shall be documented.,
e LYNCHBURG RESEARCH CENTER QUALITY ASSURANCE PROGRAM FOR RADIOACTIVE MATERIAL PACKAGES Section No. 16.0 August, 1985 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). Quality 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 audits. Quality 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 adequacy. After the time for implementation of the corrective action has elapsed, Quality Assurance shall verify the action was taken and is effective.
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 Ac-tion Report describing the deficiency and shall forward the report to the cog-nizant 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) doc-ument on the report form the results of the investigation and the corrective ac-tion, and (3) forward the report to Quality Assurance. Quality Assurance shall follow-up within a reasonable time to assure the corrective action has been im-I plemented and is effective.
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e LYNCHBURG RESEARCH CENTER QUALITY ASSURANCE PROGRAM FOR RADIOACTIVE MATERIAL PACKAGES Section 16.0 August, 1985 If a quality system deficiency is considered to be significant, Quality As-surance will immediately notify the cognizant project leader, group supervisor, section manager, and lab manager and shall require a work stoppage in the af-fected area of operation until the condition has been corrected. A report of I
this action shall be made to the Director within forty-eight hours.
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LYNCHBURG RESEARCH CENTER QUALITY ASSURANCE PROGRAM EOR RADIQACTIVE MATERIAL PACKAGES Section No. 17.0 August, 1985 QUALITY ASSURANCE RECORDS 4
R&DD has a system for preparation, collection and retention of records suffi-cient to provide documentary evidence of activities affecting quality and (where cpplicable) of the acceptability of materials, parts, or assemblies having an effect on the validity of the test or experiment. These records shall be con-sistent with applicable codes, standards, specifications, and contracts and shall be adequate for use in managing the program. The records shall be identi-fiable and retrievable.
The system encompasses those records required by each section of this 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 (as applicable) results of reviews, inspections, tests, audits, material analyses and monitoring of work performance; qualification"of personnel, proce-dures, and equipment; and other documentation such as drawings, specifications, procurement documents, calibration procedures and reports, nonconformance re-ports, and corrective action reports.
Inspection and test records shall, as a minimum, identify the inspector or per-son recording data, the type and date of observation, the results, the accept-cbility and the action taken in connection with any deficiencies noted.
The reta tion of records shall be in accordance with B&W policy and as required by contract work order or applicable codes, standards or specifications.
B&W policy provides for record retention in an established storage facility located cnd secured to prevent destruction of the records by fire, flooding, theft, and dsterioration by environmental conditions such as temperature or humidity.
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LYNCHBURG RESEARCH CENTER QUALITY ASSURANCE PROGRAM FOR RADIOACTIVE MATERIAL PACKAGES
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j Section No. 18.0 August, 1985 l
l 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 imple-mentation. Audits shall, more specifically, consist of an objective evaluation of work areas, activities, processes, and items and the review of comments and records. The audits shall be performed in accordance with written procedures or checklists by appropriately trained personnel having no direct responsibilities in the areas being audited. The audit team may employ personnel from various sections within R&DD to provide additional technical expertise and ensure a com-prehensive assessment of the activity.
Internal audits shall be performed on individual projects t'o 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 interval.
Supplier audits shall be performed when required by the provisions of Section 7.0 of this manual. R&DD procurements do not require long supplier production runs; therefore, the R&DD policy is to perform a pre-award evaluation and then monitor the supplier's quality system using selected source inspections and receiving inspection data. Supplier audits must be performed at intervals con-tistent with the importance, complexity, and quantity of the item. _ _ - _ _ _ _ _ - _ _ _ _ - _. -
e LYNCHBURG RESEARCH CDRER QUALITY ASSURANCE PROGRAM FOR RADIOACTIVE MATERIAL PACKAGES Section No. 18.0 August, 1985 9
Audit findings shall be documented in a formal audit report and transmitted to the project leader and group supervisor (for project audits), the cognizant sec-tion 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 com-mitted corrective action has been taken and is effective.
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Supplementing the formal audits is a program of informal surveillance conducted by Quality Assurance during the course of a project. The Quality Assurance Administrator 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 I
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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