ML20140E220
| ML20140E220 | |
| Person / Time | |
|---|---|
| Site: | 07100115 |
| Issue date: | 12/17/1984 |
| From: | BABCOCK & WILCOX CO. |
| To: | |
| Shared Package | |
| ML20140E219 | List: |
| References | |
| NUDOCS 8501100662 | |
| Download: ML20140E220 (62) | |
Text
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/{J THE BABC0CK & 14ILC0X COMPANY COMMERCIAL NUCLEAR FUEL PLANT SHIPPING CONTAINER QUALITY ASSURANCE PROGRAM MANUAL License No.
SilM-1168 Docket No.
70-1201
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(J Revision 0
Date 12-17-84 Approvals:
.L MANAG, ' Quality Assurance
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11Af!AER, I#terial cilities t
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Plant ihnager O
i 8501100662 841217
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SHIPPIflG C0flTAIffER l'RERCIAL flUCLEAR FUEL PLNIT QUALITY ASSURAllCE PROGRAF 1 MAtlUAL RECORD OF REVISI0tlS CHANGE DATE REY.
PAGE/ PARAGRAPH DESCRIPTI0ff 12-17-84 0
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BABCOCK a
WILCOX SECTION No.
5 COMMERCIAL NUCLEAR FUEL PLANT TABLE OF CONTEllTS
< pSHIPPING CONTAINER
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QUALITY ASSURANCE MANUAL SNM-Il68:
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1 0F
'fr 1 0F_ C0flTEf1TS SECTION TITLE 1
Table of Contents 11 Introduction 1
Organization 2
Quality Assurance Program 3
Design Control 4
Procurement Document Control 5
Instructions, Procedures, and Drawings 6
Document Control 7
Control of Purchased liaterials, Equipment, and Services 8
Identification and Control of liaterials, Parts, and Components 9
Control of Special Processes 10 Inspection 11 Test Control 12 Control of lieasuring and Test Equipment 13 Handling, Storage, and Shipping 14 Inspection, Test, and Operating Status 15 flon-conforming fiaterials, Parts, or Components 16 Corrective Action 17 Quality Assurance Records 18 Audits
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Appendix A Glossary of Terms 4
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0F 3 PAGE-DATE INDEX Section-Page flumber Date 1-1 12-17-84 11-1 12-17-84 ii-2 12-17-84 1-1 12-17-84 1-2 12-17-84 1-3 12-17-84 1-4 12-17-84 1-5 12-17-84 1-6 12-17-84 2-1 12-17-84
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op 3 PAGE-DATE INDEX Section-Page Number Date 9-1 12-17-84 9-2 12-17-84 10-1 12-17-84 10-2 12-17-84 10-3 12-17-84 11-1 12-17-84 11-2 12-17-84 12-1 12-17-84 12-2 12-17-84 12-3 12-17-84
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op 3 PAGE-DATE INDEX S'ection-Page Number Date Appendix A 1
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Si COMMERCIAL NUCLEAR FUEL PLANT INTRODUCTION
< pSHIPPING CONTAINER QUALITY ASSURANCE MANUAL SNM-ll68:
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2 INTRODUCTION PURPOSE:
This manual defines the quality assurance program to be applied by the Commercial Nuclear Fuel Plant to the design, fabrication, testing, inspection, use, and re-pair of radioactive materials shipping containers subject to the QA requirements of 10 CFR 71.
SCOPE:
CNFP management policy incorporates high standards of quality not only relative to product, but also where employee and public safety is concerned. The Quality 4
g Assurance program is established to assure that shipping containers are designed, built, and used in an orderly manner and in accord with established criteria and regulations.
Shipments of radioactive material from the CNFP are of a relatively narrow scope, consisting chiefly of:
(1) Unirradiated, low enriched fuel assemblies (2) Unirradiated scrap and waste materials as U02 p wder, pellets, or contaminated l
i material for burial.
(3) Sealed s/y emitting sources used for activation analysis, calibration, and i
other analytical purposes.
l Consequently, radioactive matarial shipping cont iners anticipated to be used by the CNFP are relatively uncomplicated and the QA program has been limited to those l
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or 2 areas where manufacturing and use specifications impact on nuclear or radiological safety. Due to the variability between container designs and types, no attempt is made in this manual to define applicability of specific requirements to individual containers, (i.e., which components are safety related) and such decisions will be made on a case-by-case basis by CNFP management.
DISTRIBUTION AND APPROVALS:
The following limitations will be applied to the distribution and use of this manual:
(1) The manual and revisions thereto will, at a minimum, be approved by the CNFP Plant Manager, Manager, Quality Assurance, and Manager, Materials and Facilities.
j (2) Distribution of the manual will be controlled by the Manager, Quality Assurance to provide assurance that there is adequate dissemination of infor-mation and maintenance of current versions in the distribution chain.
Subsequent sections of this manual describe the implementation of the criteria specified in Appendix E of 10 CFR 71. As noted above, individual consideration of the criteria is predicated on the importance of safety and proper use of a container, considering the level of risk involved.
Delegation of individual function specified within this manual may be undertaken by management in accord with established plant policy.
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COMMERCIAL NUCLEAR FUEL PLANT ORGANIZATION SHIPPING CONTAINER 1
> QUALITY ASSURANCE MANUAL SNM-Il68:
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ORGANIZATION 1.1 Scope The CNFP may fabricate containers internally or employ a vendor organization for either design or fabrication. Additionally, nuclear safety evaluations or other specialized functions may be delegated to consultant organizations.
This section provides, in general, the QA controls necessary to assure that final responsibility remains with the CNFP as the licensee, and that indi-vidual approval and QA functions within the CNFP maintain independence from the design, fabrication, and use functions.
1.2 Personnel Qualifications Personnel responsible for shipping container QA functions are deemed to be qualified in this area since current programs for the application of 10 CFR 50, Appendix B are in effect.
- 1. 3 Organization Implementation and maintenance of the QA program for manufacture (if appropriate), use, and repair of radioactive material shipping containers utilized at the CNFP shall be the responsibility of CNFP management.
CNFP organization (Figure 1) is such that the plant organizations reponsible for the QA program are functionally independent and have authority to approve procedures, implement changes or corrective actions, or terminate container use, if necessary until improper conditions have been completed and approved.
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s OF CNFP Plant l'anager a
Assurance Fe Manufacturing a
ais& Facilities
- ""C' lRegulatoryControl g
, g l Data Evaluation l
} Health-Safety]
l Production Control l Inspection & Pet Lab e
l Production Planning l t
i Figure 1 NN 9
The principal responsibilities and authorities for the CNFP Quality Control Program are vested in the following positions within the Quality Control Section.
1.3.1 Manager, Quality Assurance The direct organizational responsibility for implementing the Quality Assurance program lies with the Manager, Quality Assurance He reports directly to the Plant Manager and is wholly independent of other plant operations thus assuring independence in carrying out the Tunctions of checking, inspecting, auditing, or otherwise verifying that the work has been performed satisfactorily and that the product conforms to applicable specifications.
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QUALITY ASSURANCE MANUAL SNM-Il68:
PAGE 3 op 6 Specifically, the Manager of Quality Assurance is responsible for assuring the implementation of all quality related factors.
He is responsible for preparing the Quality Control Program relating to the purchase specifications, vendor quality, assurance requirements, vendor system audits, and inspections.
He is responsible for plant audits to assess the overall effectiveness of the quality program. He is responsible for the review and approval of all vendor quality assurance programs.
He has the authority to withhold from further processing or use any components, which do not meet the applicable specifications.
His qualifications include a degree from a recognized college and a minimum of 5 years managerial experience in quality control.
1.3.2 Supervisor, Data Evaluation The Supervisor, Data Evaluation reports directly to the Manager, Quality Assurance and has the primary responsibility for establish- !
ing and maintaining a release system for materials and/or parts purchased by or manufactured within the CNFP. This includes review of data from the Inspection Unit on incoming materials and/or components prior to release for fabrication or use. Also included in this release system is a review of inspection reports, data, and allied records to validate certification that a component was fabricated in accordance with contractual drawings and specifications. Other responsibilities include review and I
evaluation of design specifications and drawings for Quality Assurance t
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0F requirements and inspections, and approval of CNFP vendor's facilities including their QA/QC programs.
1.3.3 Inspection Manager The Inspection Manager reports directly to tne Manager, yuality Assurance and is responsible for the preparation and execution of inspection procedures to define the techniques and methods for performing inspections required to assure component compliance with applicable specifications and drawings portaining to dimensional, visual, and non-destructive inspection requirements.
Additionally, he is responsible for performing all necessary I
I Quality Control inspections in accordance with written procedures.
He is responsible for preparing procedures for the qualification of inspection equipment and personnel for Quality Control at the CNFP and for maintaining a gage control program for the periodic certification of inspection tools, gages, and quality related instruments at the CNFP.
1.3.4 Supervisor, Qua.lity Assurance Engineering The Supervisor, Quality Assurance Engineering reports directly to the Manager, Quality Assurance and is responsible for the preparation of inspection procedures and sampling plans that properly interpret applicable design specifications for safety related items. He is responsible for the sampling plans for all I
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6 op other inspections in which a sampling technique is utilized.
He is responsible for approving techniques utilized in analytical tests and metallographic examinations performed in-house or by vendors.
Additionally, he is to review and approve CNFP vendor Quality Assurance plans and perform audits of vendors to evaluate their Quality Control / Quality Assurance systems for fabricating product (s) to' meet applicable specification and drawing requirements.
Internally, he is to evaluate design / fabrication documents l
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(specifications, drawings, special instructions) and offer comments relative to their adequacy, correctness, and completeness.
He is to administer the corrective action review and the internal audit program at the CNFP in accordance with Sections 16 and 18 of this manual.
l 1.3.5 Heal th-Safety Health-Safety personnel report directly to the Regulatory Control Mana-l ger who reports to the flanager, flaterit.ls & Facilities and are responsi-sible for preparing and executing procedures that control nuclear and radiological safety. Typical Health-Safc..y responsibilities include:
appropriate inspections, radiation surveys, proper labeling of shipping container and vehicle, proper generation and retention of Health-I I
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op Safety documentation and overall enforcement of health physics and nuclear safety standards. Health-Safety has the freedom and authority, if necessary, to terminate the use of a shipping container if the nuclear or radiological standards are not met.
The Manager, Materials & Facilities is responsible to assure that container design and use is in compliance with regulatory criteria.
In the case of new container design and fabrication, the Manager, flaterials & Facilities will be responsible for coordinating and approving nuclear and radio-logical safety evaluations necessary to assure safety.
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1.4 Interrelationships Interfaces within the QA program are outlined in Figure 2.
QA Program Responsibility Technical & Cpllar..e :.upport s
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E In-Use Inspection E.F E.F Proc ure 8
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A 111tiate Act t for ordinate performance F Evalua*e Figure 2
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-1 OF 3
QUALITY ASSURANCE PROGRAM 2.1 Scope The CNFP QA program applicable to the packaging and transport of radio-active material relative to nuclear and radiological safety criteria is described in this manual. The program described in this nianual is established and approved by CNFP management with future revisions requiring equivalent approval.
Implementing procedures are also approved in writing by plant management as are revisions.
Functional CNFP organizations with primary responsibility for implementing and accomplishing the QA program are as follows:
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- Materials & Facilities in areas generally involving nuclear or radiological safety evaluations and licensing for new or modified containers, including design coordination and approval in safety related areas, preparation of operational procedures and checklists for in-spection of containers for compliance with certificates and other regulatory criteria.
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- CNFP Quality Assurance in areas involving initial and "in-use" container inspections, verification that containers are fabricated in accord with approved specifications, and application of appropriate QC procedures relative to material control / traceability, vendor QA programs and audits.
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3 OF As described in Section 1 of this manual, both of the above organiza-tions report independently to the Plant Manager.
In addition to the above, shipping containers "in use" may, on occasion,
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be inspected by other plant components for routine in-use inspection (such as Manufacturing).
In these cases, the inspection shall be conducted only in accord with written procedures or checklists approved by Materials & Facilities I
or ]A management.
2.2 Requirements Implementation of the Quality Assurance program will incorporate the follow-ing areas:
2.2.1 Personnel training and familiarization with QA, QC, and regulatory requirements as defined by management as requisite for effective control and compliance.
2.2.2 Periodic assessment of the QA Program to assure adequate implementation and effectiveness and compliance with 10 CFR Part 71, App. E criteria will be performed by personnel separate from the QA Group and at an or-ganizational level paralleling that of the QA group (or above).
2.2.3 Designation, through procedures, or equally effective means, of responsibilities for operation of the QA Program.
2.2.4 Requirements for the approval of procedures, manuals, design specifications, and other documer.ts affecting safety or regulatory compliance.
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PAGE OF 2.2.5 Identification, based on the specific container involved, of safety related components. Typically, these may include, but are not limited to:
- Structural requirements for maintenance of geometric controls or container integrity.
- Neutron absorbants.
- Radiation shielding.
2.2.6 Procedures and controls shall be maintained, as appropriate, by vendor or consulting organizations and are applied as intended.
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BABCOCK ~ a WILCOX SECTION Na.
3 COMMERCIAL NUCLEAR FUEL PLANT DESIGN CONTROL
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0F 2 DESIGN CONTROL 3.1 Scope This section describes the system by means of which effective control is exercised throughout the design of new or modified containers.
3.2 Responsibility Responsibility for design control as related to interpretation of regula-tory criteria and nuclear and radiological safety is the responsibility of the Manager, Materials & Facilities.
Project control, as related to the design program as a whole, is the responsibility of a design group designated by CNFP management.
The Manager, Materials & Facilties will coordinate nuclear, radiological, and licensing aspects closely with the design group.
In case of disagreement in these areas, the pgsition of the Manager, Materials and facilities will prevail.
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In. case of disagreement involving quality in container fabrication but not related to critical container design items (.i.e., those directly connected with nuclear safety, radiological safety or licensing matters) arising from a dif-ference in opinion between QA personnel and other department personnel, the position of Manager, Quality Assurance will prevail. I Following completion of the design, specifications and requirements for fabrication will be transmitted to the QA Manager for incorporation in the QA program as necessary. Those specifications relating to safety will be identified by the Manager, Materials and Facilities or a qualified designee.
3.3 The design control program will include provision for the following:
3.3.1 Verification of nuclear or radiological safety cal-culations.
3.3.2 Design review by the CNFP Managers of Quality Assurance and Materials and Facilities and written approval of drawings and specifications prior to release for fabrication. When a test program is used to verify the adequacy of an entirely new container I
I design, a qualification test (.i.e., drop) of a prototype unit under design conditions will be used.
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PAGE OF 3.3.3 The review shall consider the following as appropriate:
3.3.3.1 Adequacy of calculations.
3.3.3.2 Compliance with applicable provisions of the Code of Federal Regulations.
3.3.3.3 Accident evaluations.
3.3.3.4 Inspection, maintenance, and repair criteria.
3.3.3.5 Structural design, materials of construction, and purchased parts relative to maintenance of safety.
3.3.4 Review and approval of proposed modifications or revisions affect-ing safety by the Manager, Materials & Facilities or his qualified I
designee.
3.4 When proposed design changes may affect safety limitations or controls, dasign review criteria equivalent to that described above will be implemented.
3.5 The following activities will be documented in writing:
3.5.1 Detailed nuclear and radiological evaluations and acceptance thereof.
3.5.2 Specific safety criteria upon which container design is based.
3.5.3 Results of final design evaluations, identification of " problems",
or questionable areas and their resolution.
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BABCOCK ~ a WILCOX SECTION Ns.
4 COMMERCIAL NUCLEAR FUEL PLANT PROCUREMENT DOCUMENT CONTROL SHIPPING CONTAINER
, QUALITY ASSURANCE MANUAL 4
SNM-Il68:
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OF 3 PROCUREMENT DOCUMENT CONTROL 4.1 Scope This section describes the method of control exercised at the CNFP to assure that all requirements relative to nuclear and radiological safety and container structural integrity are suitably included or referenced in documents used to procure materials, components, and services. Quality Assurance shall verify that the procurement documents for shipping containers which have been transmitted to the supplier are complete with respect to technical and quality requirements defined in the applicable specifications and drawings and the applicable 10 CFR Part 71, Appendix E requirements which l
I must be complied with as described in the supplier's QA program. Any changes to procurement documents shall be handled in like manner.
4.2 Requirements
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4.2.1 For fabrication of shipping containers, a bill of materials shall be prepared by the responsible engineering group which consolidates such information as drawings and specifications, and special test requirements. The responsible engineering function may also prepare a purchased materials list (if required) for those items which are to be procured. Both documents, i.e., the bill of materials and the purchased materials list are reviewed for conformance with applicable l
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3 SNM-Il68-PAGE OF specifications, and these specifications shall be clearly defined to the supplier.
4.2.2 Technical requirements normally are contained in the applicable drawings and specifications. The technical requirements can be supplemented or defined completely by supplementary documents prepared by the design group. Supplementary documents shall not modify the design or functional requirements specified by the applicable drawing or specification.
4.2.3 Quality requirements are contained in the applicable drawings and specifications.
Specific quality requirements may be supplemented, defined, or amplified by a Quality Control Require-ment ("QCR") prepared by CNFP Quality Control.
The QCR shall not modify the quality requirements specified by the applicable drawing or specifications.
4.2.4 Engineering and quality requirements which apply to the procure-ment of materials or components shall be specified in the purchased materials list. The vendor program for record retention, con-trol and disposition requires specific Quality Assurance appro' val.
4.3 Production Control shall prepare a purchase requisition for transmittal to the Purchasing Department. The requisition shall denote all of the technical and quality requirements covered in this list along with such schedular information as quantities and delivery dates.
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0F 3 4.4 The Purchasing Department shall prepare a purchase order for transmittal to an approved vendor from the information contained in the purchase requisition. The purchase order shall be checked to verify that the technical and quality requirements in this procurement document are satis factory.
4.5 In general, the major purchased materials, components, and services shall be procured only from vendors who have been evaluated and audited for acceptability with respect to manufacturing and/or technical capability, and their quality assurance program. Such vendors shall be noted on approved vendor list which is maintained I
I by Quality Assurance and submitted to the Purchasing Department for use in their procurement activities.
The use of non-approved vendors shall be approved on a case-by-case basis, by the Managers of Quality Assurance and Materials & Facilities.
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BABCOCK ~ a WILCOX SECTION No.
5 COMMERCIAL NUCLEAR FUEL PLANT IflSTRUCTIONS, PROCEDURES, & DRAWINGS
< > SHIPPING CONTAINER QUALITY ASSURANCE MANUAL i
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SNM-Il68:
PAGE OF If1STRUCTIONS, PROCEDURES, & DRAWINGS 5.1 Scope Effective control of fabrication and use of radioactive material shipping containers necessitates the use of approved written procedures and equiva-lent documentation such as user instructions, drawings, and specifications.
This section provides general criteria for use and content of instructions, procedures, and drawings.
5.2 Requirements Procedures, instructions, or drawings, as applicable, will be used for the following QA related activities:
5.2.1 In-house fabrication of shipping containers or components (if applicable) 5.2.2 Qualification testing of containers or components.
5.2.3 Inspection and audit of fabrication activities (at CNFP or vendor facility).
5.2.4 Periodic audit of CNFP shipping container QA program.
5.2.5 Routine in-use inspection of shipping containers.
Procedures, instructions, and drawings will contain sufficient informa-tion relating to regulatory requirements, specifications, and acceptance criteria to allow complete and effective application by user personnel.
Existing CNFP systems provide detailed requirements for the content and organization of procedures such that format standardization assures comprehensive coverage, logical sequencing, and appropriate approvals.
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s COMMERCIAL NUCLEAR FUEL PLANT INSTRUCTI0tlS, PROCEDURES, & DRAWIf1GS SHIPPING CONTAINER
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2 0F CliFP policy prohibits implementation of procedures prior to receipt of all required approvals.
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0F 3 DOCUMENT C0flTROL 6.1 Scope The control of instructions, procedures, or drawings within the CNFP is the responsibility of the originating unit.
This section describes the system whereby such documents, relating to QA, are maintained in a current status and are properly approved and distributed.
6.2 Requirements 6.2.1 Prior to issue, design specification, construction drawings, procurement documents, and design change requests will be approved by the Managers of Quality Assurance and lkiterials and l
I Facili ties.
Prior to approval, responsible managers will take any necessary steps to assure themselves that the document is correct and, if applicable, that proposed revisions do not alter safety criteria.
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6.2.2 The shipping container QA Manual and revisions thereto will be approved by the Plant Manager, Quality Assurance Manager, and Manager Materials & Facilities.
6.2.3 Operating instructions and procedures will be approved by the Manager of the originating section and if other than Quality Assurance or Materials and Facilities, by the Managers of those sections. Documents that are necessary in perfonning a particular work function will be available at the work station prior to conmencing the activity.
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PAGE 2 OF 3 6.2.4 Non-conformance findings are reported to the Quality Assurance and Materia.. and Facilities Managers for review and, by l
consultation with appropriate design or operating personnel, determination of disposition. Non-conformance reports and sub-sequent actions shall be documented.
Containers in a non-conformance status will be identified and withheld from use or further fabrication until resolution is obtained.
6.2.5 The section assigned responsibility for preparing a document is also responsible for obtaining the required approval signatures, controlling the distribution, initiating modifications as required.
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and assuring that pages that have been superseded are removed from the revised document.
6.2.5.1 The originating CNFP section shall be responsible for transmitting to individuals / sections on distribution those documents for which they have sole responsibility of main-taining and having the individual /section acknculedge receipt by signature.
6.2.5.2 Once receipt is made it then becomes the responsibility of the document recipient to distribute the new or revised document as necessary and remove and destroy all obsolete documents.
(Files wherein outdated documents, specifications, and drawings are retained for historical purposes are exempt from this requirement.)
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PAGE op 6.2.5.3 The section responsible for originating the document is also responsible for assuring that changes to docu-ments have the same reviewing and approval authority as the original issue.
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BABCOCK ~ a WILCOX SECTION No.
7 COMMERCIAL NUCLEAR FUEL PLANT CONTROL OF PURCHASE fMTERIAL,
< pSHIPPING CONTAINER EQUIPMENT, AND SERVICES QUALITY ASSURANCE MANUAL SNM-Il68:
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0F C0flTROL 0F PURCHASED MATERIAL, EQUIPMENT, AND SERVICES 7.1 Scope s
To assure that purchased material, equipment and services conform to purchase' specifications, specific evaluations of vendor capabilities are made consistent with the importance, complexity, and quantity of the product or services. This is accomplished through an evaluation of the vendor's quality program and inspection of the product received at the CNFP.
7.2 Requirements 7.2.1 Prior to procurement of items considered as critical to safety l
I an on-site evaluation shall be made of the vendor's facilities with respect to his quality program assuring that he can effec-tively demonstrate the controls within his own plant and those of this subcontractors to provide the quality that is required.
The vendor's Quality Manual outlining the quality plan to be in effect requires CflFP approval prior to commencing production of B&W purchased material.
7.2.1.1 The evaluation is performed in accordance with a check list.
7.2.1.2 Vendors who have been adjudged as being acceptable per
^
this evaluation are then placed on an Approved Vendor's Li s t.
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BABCOCK ~ a WILCOX SECTION No.
7 COMMERCIAL NUCLEAR FUEL PLANT CONTROL OF PURCHASE MATERIAL, t > SHIPPING CONTAINER E UIPMENT, AND SERVICES QUALITY ASSURANCE MANUAL SNM-ll68:
PAGE: _2 0F 3 7.3 Vendors supplying material, components, or services shall be audited during periods of procurement or fabrication activities in accordance with written procedures for the purpose of ensuring that quality requirements are being met and maintained. The audits shall be conducted in accord with a planned agenda covering such vendor operations as QA program implementation, inspection activities, QA records, etc., as covered by the applicable Quality Control Requirement.
~.
7.4 As deemed necessary when it is either impractical or undesirable to inspect purchased item (s), the supplier shall furnish to-the B&W inspector necessary facilities, equipment, or data to meet the required inspection criteria.
CNFP may elect to perform inspection at supplier's plant wherever:
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7.4.1 Required inspection of the item before fabrication is desired.
7.4.2 Rejection subsequent to receipt at the CNFP, would result in either ultimate delivery delay or increased cost or both.
7.4.3 Inspection of a larger quantity of identical items or a~small percentage of a large quantity can be performed more efficiently at supplier's plant.
7.4.4 First-piece inspection at the supplier's facility is desired.
l 7.4.5 At the discretion of the Manager, Quality Assurance or fianager, Materials and Facilities.
7.5 Incominq mat.erials and components shall undergo a receivino insoection prior to release of such items for use. These inspections shall be in l
accord with written procedures and instructions which cover the type of l
Date 12-17-84 Rev.
o
BABCOCK ~ a WILCOX SECTION No.
7 COMMERCIAL NUCLEAR FUEL PLANT CONTROLbFpURCHASEMATERIAL,
( > SHIPPING CONTAINER EQUIPMENT, AND SERVICES QUALITY ASSURANCE MANUAL 3
3 SNM-ll63:
PAGE OF test or inspection applicable to the item.
7.5.1 Concurrent with the appropriate inspections, all QA documentation which the vendor is required to submit shall be reviewed for completeness and compliance with applicable drawings and specifi-cations by Quality Assurance.
7.5.2 Items which have been determined to comply with the receiving inspection and QC documentation requirement shall be released by means of a Material / Components Release issued by Quality Assurance 7.6 Results of audits and any follow-up activities shall be retained on file by Quality Assurance.
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BABCOCK ~ a WILCOX SECTION No.
8 COMMERCIAL NUCLEAR FUEL PLANT IDENTIFICATION AND CONTROL OF SHIPPING CONTAINER
!!ATERIALS, PARTS, AND COMPONENTS QUALITY ASSURANCE MANUAL i
3 SNM-Il68:
PAGE OF IDENTIFICATION AND CONTROL 0F ftATERIALS, PARTS, AND COMPONENTS r
8.1 Scope This section describes the techniques used by CNFP to identify and control radioactive material shipping containers and materials, parts, or components where fabrication is at the CNFp to provide traceability and to assure that only acceptable parts are utilized in the fabrication of radioactive material shipping containers where specification of those parts or materials is based on safety or licensing requirements.
Identification of materials and parts it?portant to the function of safety related system and components can be traced to the appropriate documentation such as, for example, drawings, specifications, purchase orders, manufacturing and inspection documents, deviation reports, and physical and chemical mill test reports. The location and method of identification as outlined in Chapter 8 will not affect the fit,
e functions or quality.
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8.2 Requirements 8.2.1 Incoming Material, Parts, and Components 8.2.1.1 The flaterial Control section is respon-sible for the receipt of all incoming radioactive material shipping containers and material, parts, and components at the CIFP.
The receipt shall be documented and a copy of the receiving notification shall be forwarded to Quality Assurance 8.2.1.2 Upon receipt of this notification, the QA Data Evaluation j
Unit shall prepare and submit a request to the Inspection Unit delineating the type of inspection, i.e., dimensional, 7
l visual, chemical analysis, etc., and the Quality Control procedure to be applied in the inspection.
8.2.1.3-The results of this inspection shall be reviewed along with the vendor certification of physical, chemical, non-destructive testing, and dimensional inspection as l
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BABCOCK ~ a WILCOX SECTION No.
8 COMMERCIAL NUCLEAR FUEL PLANT
< > SHIPPING CONTAINER E U','is'!EeMn P " * " " '
QUALITY ASSURANCE MANUAL SNM-Il68:
PAGE 2
3 op specified in the purchase order for compliance with the applicable specifications and drawings by the Data Evalua-tion Unit. Quality Assurance shall prepare a material release document.
8.2.1.4 Upon completion of all required inspections and certifi-cations at the CNFP, the Quality Assurance and Materials and Facilities groups shall be advised as to the acceptability of the material or components in question. Both groups d -11 review for compliance with the required specifications. Non-conforming parts, I
I materials, and components will be handled as prescribed in Section 15 of this QA manual.
8.3 Traceability 8.3.1 The program used to control and identify material and components is based on distinguishing between two (2) general categories; bulk traceability and unit traceability.
8.3.1.1 All sub-components which are identified with a serial number or other specific identifier shall be subject to unit traceability.
8.3.1.2 All sub-components which are manufactured from common material, as for example, container shells, shall be subject to bulk traceability through final inspection i
I Date
-'7-84 Rev.
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BABCOCK' 8 WILCOX SECTION No.
8 COMMERCIAL NUCLEAR FUEL PLANT IDENTIFICATION AND CONTROL OF
< pSHIPPING CONTAINER MATERIALS, PARIS, AND COMPONENTS QUALITY ASSURANCE MANUAL SNM-Il68:
PAGE 3 op 3 prior to committing such components to manufacturing operations.
8.3.1.3 Unit traceable components can be produced by utilizing bulk traceable items from lots of acceptable material as, for example, a fuel assembly shipping container.
8.3.2 Unit traceability may be used in lieu of bulk traceability at the option of the CNFP and/or the vendor.
8.4 Inspection - completed components are withheld from use until the follow-ing actions have been completed:
8.4.1 All inspections have been completed and the results of these l
I inspections have been reviewed for compliance with applicable specifications and drawings.
8.4.2 All documentation has been verified for completeness and accuracy.
8.4.3 Prior to first use of a shipping container all necessary safety, nuclear and radiological inspections must be completed and documented by the responsible group as being released for use.
8.5 Non-conforming containers shall not be used until:
8.5.1 The non-conforming condition or item has been repaired, replaced, or reworked in accordance with approved procedures to restore it to the design specification and/or drawing requirements.
8.5.2 The non-conforming condition has been approved by the cognizant engineering organization with design responsibility and Materials j
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and Facilities.
Date 12-17-84 b.
0
BABCOCK a
WILCOX SECTION No.
9 COMMERCIAL NUCLEAR FUEL PLANT CONTROL OF SPECIAL PROCESSES SHIPPING CONTAINER
> QUALITY ASSURANCE MANUAL SNM-Il68:
PAGE 1 0F 2 CONTROL 0F SPECIAL PROCESSES 9.1 Scope This section sets forth the measures taken to assure that special processes necessary where the required level of qnality cannot be assured by inspec-tion alone are controlled and accomplished using qualified personnel and procedures. Quality Assurance shall be responsible for qualifying those processes under their direct cognizance that are so complex or specialized in nature, or so critical to the product, that more than routine measures are necessary in training personnel and implementing the process.
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9.2 Requirements Curing the review of design specifications and drawings which are to be released for fabrication purposes. Quality Assurance and the appropriate design group shall:
9.2.1 Identify wila't production and inspection processes shall require procedure, equipment and/or personnel qualification to assure quality of the final product.
9.2.1.1 Qualification shall be required to:
(a) Comply with design requirements.
(b) Comply with Quality Assurance program require-ments for the control of special processes.
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BABCOCK' a WILCOX SECTION No.
9 COMMERCIAL NUCLEAR FUEL PLANT CONTROL OF SPECIAL PROCESSES SHIPPING CONTAINER q, QUALITY ASSURANCE MANUAL SNM-Il68:
PAGE 2 0F 2 (c) Validate sampling plans, methods revisions or condition optimization which provide for manufacturing economies.
9.2.2 Direct the vendor to prepare procedures for the qualification of personnel and equipment.
9.2.2.1 Direct the qualification in conformance with the procedures.
9.2.2.2 Evaluate and determine the acceptability of the results in relation to the appropriate acceptance cri teria.
(
)
9.2.2.3 Records of the qualification procedure and the qualified equipment, process, and/or personnel shall be maintained by the CNFP or by the vendor's Quality Assurance organization.
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BABCOCK' &
WILCOX SECTION No.
10 COMMERCIAL NUCLEAR FUEL PLANT q > SHIPPING CONTAINER QUALITY ASSURANCE MANUAL SNM-il68:
PAGE 1 0F 3 IflSPECTION
- 10. 1 Scope The CNFP inspection program is conducted in accordance with standards and documented procedures which incorporate the quality requirements defined in applicable specifications and drawings. The procedures encompass the necessary inspections setting forth minimum requirements for acceptance.
Appropriate inspectors are qualified in accordance with applicable codes, standards, and company training programs; and their qualifications and cer-tifications dre kept current.
It is the responsibility of the Quality Assurance Section to assure that these requirements are fulfilled.
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10.2 Requirements 10.2.1 Source or Receiving Inspection All purchased items which effect quality of the final product shall be either source or receipt inspected by Quality Control ;or the vendor under an approved procedure.
Such inspection shall consist of the following:
10.2. 1.1 Review of vendor certification and test reports to as-certain conformance to the CNFP requirements.
10.2. 1.2 Sampling for receiving inspection operations, when needed, shall be in accordance with MIL-STD-105D or an alternate plan approved in a manner consistent with the product quality requirement. Samples shall be selected at random for lots, batches, or groups of components.
10.2. 1.3 Any non-conforming components shall be processed per bie 1?_17_i34 KW.
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BABCOCK' a WILCOX SECTION No.
10 COMMERCIAL NUCLEAR FUEL PLANT q 6 HIPPING CONTAINER QUALITY ASSURANCE MANUAL 2
3 SNM-Il68:
PAGE OF Section 15 of this manual, "Non-Conforming Materials, i
Parts, or Components." Non-confonning components shall not be released for production until the defective condition is either corrected or the deviation is accepted in the manner outlined in Section 15. Modi fications, repairs, and replacements are inspected in accordance with the original design and inspection requirements or acceptable alternatives.
10.2.1.4 Components shall also be inspected for cleanliness, proper identification, and other CNFP/ Vendor requirements.
10.2. 1.5 Following the receipt and satisfactory review of all necessary reports, and subsequent verification that the material or parts are acceptable, formal acceptance shall be made as defined in Section 8 of this manual.
10.2. 1.6 The CNFP Quality Assurance and Materials and Facilities Sections shall be responsible for decisions affecting B&W acceptability of product, except in such instances where Section 15 of this manual may be invoked.
10.2. 1. 7 All components scheduled for non-destructive testing shall l
be tested in accordance with the limits set forth in applicable specifications and drawings, or more extensive testing as determined by ~
10.3 Final Inspection Final inspection shall be performed by the Inspection Unit on completed D
l components prior to use in the following manner:
Rev.
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BABCOCK' a WILCOX SECTION No.
10 COMMERCIAL NUCLEAR FUEL PLANT INSPECTION q pSHlPPING CONTAINER QUALITY ASSURANCE MANUAL 3
3 SNM-Il68:
PAGE OF 10.3.1 Components shall be inspected according to detailed inspection procedures, prepared to insure the verification of all specified quality requirements.
- 10. 3.2 All as-built dimensions shall be' compiled and forwarded to the cognizant design agency as required by specifications.
10.3.3 All acceptable components shall be released for further processing rpon completion of final inspection.
10.3.4 All deviated components shall be treated in accordance with Section 15 of this manual.
10.3.5 All final inspection data shall be maintained and stored as defined
(
)
in Section 17 of this manual.
10.4 If witness or mandatory hold points are listed in the documents as a con-dition of release for further fabrication, such points shall be included in the Inspection process outline. The cognizant design or procurement agency shall be notified as required in order to allow such agency to perform the specified surveillance.
i Date 12-17-84 Rev.
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BABCOCK' 8 WILCOX SECTION No.
11 COMMERCIAL NUCLEAR FUEL PLANT TEST CONTROL 4 > SHIPPING CONTAINER QUALITY ASSURANCE MANUAL SNM-Il68:
PAGE 1 0F 2 TEST CONTROL 11.1 Scope The components manufactured at or for the CNFP are inspected for compliance with design specifications and drawings by one or a codination of the fol1owing techniques:
11.1.1 Various methods of metrology to verify dimensional requirements.
11.1.2 Verification of mechanical properties and chemical requirements to meet material requirements.
11.1.3 Additionally, a program shall be maintained to assure that all testing activities affecting quality and serviceability of I
I nuclear material shipping containers are identified and performed as prescribed in procedures. These testing activities include but are not necessarily limited to those tests which are per-formed on new shipping container designs to evaluate the durability and integrity as originally specified.
-11.2 Requirements 11.2.1 Testing 11.2.1.1 Any prerequisites that are essential for the proper exe-cution of a given test will be outlined in appropriate procedures. Acceptance criteria shall be incorporated in test procedures.
11.2.'1.2 Adequate test instrumentation will be available and used as required in procedures.
Me 12.-17-84 Rev.
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BABCOCK ~ 8 WILCOX SECTION Ns.
u COMMERCIAL NUCLEAR FUEL PLANT TEST CONTROL
< pSHIPPING CONTAINER QUALITY ASSURANCE MANUAL SNM-Il68:
PAGE 2 OF 2 11.2.1.3 Tests will be performed under conditions suitable to give representative test results as stated in procedures and required by applicable regulations.
11.2.1.4 Modifications, repairs, and replacements are tested as required in accordance with the original design and testing requirements or acceptable alternatives.
11.3 Documentation Essential testing will be performed by the design and/or fabrication vendor and will be documented and final evaluation shall be performed
(
)
by Quality Assurance and Materials and Facilities to assure test requirements have been satisfied.
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BABCOCK ~ a WILCOX SECTION No.
12 COMMERCIAL NUCLEAR FUEL PLANT CONTROL 0F MEASURING AND TEST EQUIPMENT t pSHIPPING CONTAINER QUALITY ASSURANCE MANUAL SNM-ll68:
PAGE 1 0F 4 CONTROL 0F MEASURING AND TEST EQUIPMENT 12.1 Scope This section sets forth measures in effect at the CNFP to assure that all measuring and test equipment used in activities affecting quality and safety are properly controlled, calibrated and adjusted to maintain accuracy within necessary limits.
It is the responsibility of Quality Assurance to assure that proper procedures are followed for active gages, measuring devices, and inspectjon fixtures under their respective control.
12.2 Requirements - Quality Control Equipment 12.2.1 New or Reworked Equipment 12.2.1.1 When applicable equipment used as media of inspection for quality verification shall be initially calDrated against available known standards traceable to the National Bureau of Standards. The Inspection Unit shall be responsible for filing the certifications of all measuring standards and the institution of re-certification and re-calibration shall be in accordance with a detailed written procedure.
12.2.1.2 For the inspection equipment wherein standards traceable to the National Bureau of Standards are not available, the manufacturer's certificate of accuracy shall be l
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BABCOCK' a WILCOX SECTION Ns.
12 COMMERCIAL NUCLEAR FUEL PLANT C0flTROL 0F MEASURIllG AtlD TEST EQUIPMENT SHIPPING CONTAINER
' QUALITYASSURANCE MANUAL 4
SNM-Il68:
PAGE 2 or 4 retained in the files of the Inspection Unit. The manufacturer's recommendation as to the manner and frequency of calibration shall be utilized.
12.3 Storage of Equipment 12.3.1 When equipment must remain permanently in the work area, adequate means for protection and cleanliness will be provided within the limits of work requirements.
12.3.2 Provision will be made to assure proper protection and cleanliness of all equipment not in actual use.
12.3.3 Any gage to be repaired shall be immediately placed in the Gage Control detention area, under the sole control of the Calibration Control Technician until such time as it has been repaired, re-calibrated and formally released for use by Gage Control.
12.3.4 ':! hen the inspections are performed by vendors, any equipment used shall be stored and protected in a manner that will meet l
the limits of work requirements. Any malfunctioning equipment will immediately be taker, to a proper detention area and remain there until it is properly repaired, recalibrated, and released for use.
1 12.4 Periodic Inspection of Equipment 12.4.1 All inspection gages shall be examined, calibrated, and/or serviced at scheduled intervals specified in detailed procedures I
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i BABCOCK' 8 WILCOX SECTION No.
12 COMMERCIAL NUCLEAR FUEL PLANT CONTROL OF MEASURING AND TEST EQUIPMENT
< > SHIPPING CONTAINER QUALITY ASSURANCE MANUAL SNM-Il68:
PAGE 3
op 4 by personnel who are specifically charged with the responsibility of maintaining accurate gage and related records.
12.4.2 Additional gage inspection shall be made when there is evidence of excessive wear, suspected or actual instrument damage.
12.4.3 The inspector, when using relatively simple gages such as micro-meters, which can be checked readily for accuracy, shall check them with known standards during usage of such gages.
12.4.4 Any gage or equipment utilized in the inspection process which is l
determined to exceed the established calibration accuracy limits shall be subject to the following action.
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(a) Removal from service and stored in an appropriate detention area.
(b) Determine disposition of the gage, i.e., rework, recalibrate or scrap and replace.
(c) Reworked gages shall be recalibrated prior to return to service. The corrective action for the reworked and/or recalibrated gages shall be recorded on the calibration record card.
12.4.4.*
All components measured with a gage or equipment that has exceeded the established calibration accuracy limits shall be reinspected with correctly calibrated equipment.
This reinspection shall cover all components, assemblies, etc. inspected with the gage or tool to the last acceptable I
k calibration.
bie 12-17-84 Rw.
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BABCOCK B
WILCOX SECTION No.
12 COMMERCIAL NUCLEAR FUEL PLANT CONTROL OF MEASURING AND TEST EQUIPMENT
< > SHIPPING CONTAINER QUALITY ASSURANCE MANUAL 4
4 SNM-Il68:
PAGE OF 12.5 Requirements - Radiation Monitoring Equipment 12.5.1 Radiation Survey and Analysis Equipment Such equipment shall be calibrated and maintained as specified in SNM-1168.
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BABCOCK ~ a WILCOX SECTION No.
13 COMMERCIAL NUCLEAR FUEL PLANT HANDLING, STORAGE, AND SHIPPING t > SHIPPING CONTAINER QUALITY ASSURANCE MANUAL SNM-Il68:
PAGE 1
0F 2 HANDLING, STORAGE, AND SHIPPING 13.1 Scope This section sets forth measures in effect at the CNFP to control the cleanliness, preservation, packaging, shipping, and storage of components and assemblies to prevent damage or deterioration from start of fab-rication through receipt by customer.
It is the responsibility of all operating CNFP sections to follow detailed process procedures which will establish the methods and techniques to be followed to prevent damage to components. Specifically, the Quality Assurance Section shall verify that the ccmponents are adequately protected according to procedures listed below.
13.2 Requirements General 13.2.1 All assembly operations shall be carried out in an area adequate to permit the attainment of the final cleanliness level specified.
13.2.2 After completion of final visual and dimensional inspection, the cleanliness of acceptable components shall be maintained by suitable means to comply with the cleanliness requirement of applicable specifications.
13.3 Handling of Major Components 13.3.1 All major handling devices such as cranes, slings, and other devices used for the purpose of lifting or transporting major I
I ggg 12-17-84 Rev.0
BABCOCK ~ a WILCOX SECTION No.
13 COMMERCIAL NUCLEAR FUEL PLANT HAflDLING, STORAGE, AND SHIPPING
< > SHIPPING CONTAINER QUALITY ASSURANCE MANUAL 2
2 SNM-Il68:
PAGE OF components shall be subject to periodic inspections in accordance with written procedures.
13.3.2 Major components shall be defined as individual shipping containers.
13.3.3 Prior to each use, shipping containers are inspected for compliance with applicable regulatory controls including certificates of com-pliance and the Code of Federal regulations.
13.3.4 All necessary shioning papers will be prepared and processed as required.
Shipment and receipt of a package will be monitored in accord with 10 CFR Part 71.
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BABCOCK a
WILCOX SECTION No.
14 COMMERCIAL NUCLEAR FUEL PLANT
< > SHIPPING CONTAINER Ef15UN, TEST,ANDOPERAUNG QUALITY ASSURANCE MANUAL SNM-Il68:
PAGE 1 0F 2 INSPECTION, TEST, AND OPERATING STATUS 14.1 Scope This section sets forth measures in effect at the CNFP to indicate the status of inspections and tests performed on shipping container.
14.2 Requirements The status of inspection operations for components which are to be supplied to or used by the CNFP shall be documented. Bypassing of required inspections, tests, and other critical operations is procedurally controlled.
14.2.1 New Container Inspection 14.2.1.1 Receiving inspection on incoming containers shall be performed in accord with approved Quality Assurance and l
I Materials and Facilities procedures.
If the items are found to be acceptable, appropriate documenta-tion shall be generated to indicate acceptability.
14.2.1.2 Any items determined to be non-conforming shall have a
" Hold" tag attached to the item.
If the assessment of the non-conforming condition established that rework is i
permitted, a " Rework Required" tag shall be attached to the item. Only the Inspection Unit shall remove any
" Hold" or " Rework" tags from an item.
14.2.1.3 Any item deemed to be unacceptable and assessed to be not subject to rework or repair shall have a " Reject" tag attached to it and shall be segregated from conforming units to await final disposition.
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BABCOCK' 8 WILCOX SECTION No.
14 COMMERCIAL NUCLEAR FUEL PLANT IflSPECTIO!!, TEST, AtlD OPERATI lG ~
q > SHIPPING CONTAINER status QUALITY ASSURANCE MANUAL SNM-Il68:
PAGE 2
0F 3 14.3 Final Inspection 14.3.1 Containers which have completed the final inspection operation shall have an " Inspection Complete" tag attached by the Inspection Group.
This tag will indicate that all inspection operations are complete and the data has been submitted to the Data Evaluation Group for appropriate certification and documentation. The tag may be removed when container is placed in service.
If rework is necessary a
" Rework Required" tag shall be attached.
Only the Inspection Group shall remove rework tags.
14.3.2 Under no circumstances shall a non-confonning component which has l
I been processed through final inspection be used until the discrepant condition has been corrected.
14.4 In-Use Inspection 14.4.1 In-use inspection shall be performed by Quality Assurance and l
Materials and Facilities in accordance with approved procedures.
14.4.2 Any item or component found to be non-conforming during in-use inspection shall have a " Hold" tag attached to it indicating a deviation which may require a repair, rework, reject, or, use as is, disposition.
t 14.4.2.1 If rework is required, a " Rework Required" tag shall be attached to the component by the Inspection Unit. This l
tag can be removed only by this unit from the defective l
component.
b le 12-17-84 Rev.
o 1
BABCOCK ~ 8 WILCOX SECTION No.
14 COMMERCIAL NUCLEAR FUEL PLANT INSPECTION, TEST, AND OPERATING _
SHIPPING CONTAINER s w us
, QUALITY ASSURANCE MANUAL q
SNM-Il68:
PAGE 3
op 3 14.4.2.2 Any component classified as reject shall have a
" Reject" tag attached to it and shall be processed per paragraph 14.2.1.3.
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r BABCOCK ~ a WILCOX SECTION No.
15 COMMERCIAL NUCLEAR FUEL PLANT NON-CONFORMING MATERIALS, PARTS, OR 1 > SHIPPING CONTAINER COMPONENTS QUALITY ASSURANCE MANUAL I
3 SNM-Il68:
PAGE 0F NON-CONFORMING MATERIALS, PARTS, OR COMP 0NENTS 15.1 Scope This section sets forth the measures taken by the CNFP to control shipping containers or components which do not conform to requirements in order to prevent subsequent use until the non-conformance is corrected.
It is the responsibility of CNFP Quality Assurance to assure that the following require-ments are fulfilled on non-conforming units.
15.2 Raquirements General 15.2.1 All non-conforming components shall be documented by Quality Assurance.
15.2.2 All non-conforming components shall be separated from conforming components and identified (tagged, marked) as being non-conforming.
15.2.3 Sufficient data shall accompany the non-conforming component to identify its non-conforming condition.
(Such data is not required for any component or item which has been assigned to be scrapped.)
15.2.4 Quality Assurance shall recommend the disposition of the non-conforming components.
15.3 Non-Conformance Disposition 15.3.1 Component non-conformance at receiving or in use shall be documented.
The report shall be prenared by Quality Assurance for submittal to the Design Group and Materials and Facilities.
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BABCOCK' a WILCOX SECTION No.
15 COMMERCIAL NUCLEAR FUEL PLANT NON-CONFORMING MATERIALS, PARTS, OR
< > SHIPPING CONTAINER COMPONENTS QUALITY ASSURANCE MANUAL 2
3 SNM-Il68:
PAGE OF 15.3.2 The Design Group and Materials ana Facilities shall review the completed report and recommend disposition.
15.4 Contract Variation Approval Notice (CVAR) 15.4.1 To obtain approval of a non-conforming item, a CVAR shall be pre-pared by Quality Assurance listing the details relevant to the devia-tion.
15.4.2 The CVAR shall be evaluated by the Design Group and a recommended course of action indicated on the CVAR.
15.4.3 Upon completion of this evaluation, the Design Group shall fonvard the CVAR to the Data Evaluation Group of CNFP Quality Assurance for 4
I formal submittal to the cognizant design agency for disposition.
15.4.4 Upon receipt of the dispositioned CVAR, Quality Assurance shall notify the proper personnel of the final decision and appropriate steps to take consistent with the decision, whether it be to reject, accept, or r.epair according to an approved procedure.
15.5 Repair of Non-Conforming Components 15.5.1 In the event of a repair, the CNFP or vendor facility shall cite either an existing repair procedure or prepare a special procedure. All CNFP repair procedures shall be reviewed and approved by Quality Assurance.
15.5.2 After the repair has been completed, the component shall be inspected for conformance to the applicable CVAR disposition or design criteria or both.
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12-17-84
BABCOCK ~ a WILCOX SECTION No.
15 COMMERCIAL NUCLEAR FUEL PLANT NON-CONFORMING MATERIALS, PARTS, OR
< > SHIPPING CONTAINER COMPONENTS QUALITY ASSURANCE MANUAL SNM-II68:
PAGE 3
3 op 15.5.4 Inspection of reworked components shall be to the applicable design criteria and shall be documented.
15.6 Reject or Non-Conforming Components 15.6.1 Material and components which have been rejected shall be tagged by Inspection and placed on Hold in a designated area.
15.6.2 Materials and components which are to be returned to the vendor shall be processed in the following manner:
15.6.2.1 Data Evaluation will fill out a claim report for transmittal to the vendor by the Purchasing Department.
15.6.2.2 The Design Group shall review and indicate corrective I
I action required by the vendor on the form.
15.6.2.3 Purchasing shall fill out the remainder of the claim report form and foniard to the vendor along with non-conforming components. A copy of the completed form shall be sent to CNFP Quality Assurance.
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BABCOCK' 8 WILCOX SECTION No.
16 COMMERCIAL NUCLEAR FUEL PLANT CORRECTIVE ACTION
< > SHIPPING CONTAINER QUALITY ASSURANCE MANUAL i
2 SNhil68:
PAGE OF CORRECTIVE ACTION 16.1 Scope This section sets forth the measures in effect at the CNFP to assure that conditions adverse to quality in safety related areas such as defective material, non-conformances to design specifications and drawings, deficiencies, and non-compliances to approved procedures are promptly identified and corrected.
It shall be the responsibility of the Quality Assurance Section and liaterials and Facilities to bring to the attention of CNFP plant management, any condition adverse to quality and to verify that the appropriate corrective action has been taken to preclude its repetition.
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16.2 Requirements flon-Conformance Review 16.2.1 All Contract Variation Approval Notices covering non-conforming components shall be analyzed by a Review Board including represen-tatives from the Supervisory and/or Management Levels of Quality Assurance and Materials and Facilities.
16.2.2 This review shall.be conducted periodically as scheduled by the Manager of Quality Assurance.
16.2.3 The purpose of the review shall be to analyze the deviated conditions for chronic recurrence, determination of cause, and to recommend the corrective action to be implemented. Also, follow-up shall be performed on corrective action established D
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PAGE OF at previous rr.aetings to ascertain the status and effectiveness of the measures taken.
16.2.4 Quality Assurance shall be responsible for documenting the results of the meetings and listing all CVAR's and component discrepancy reports on a CVAR summary and corrective action report along with the corrective action taken on each.
Also, included in the report shall be the follow-up performed on previous corrective actions.
16.2.5 The Manager, Quality Assurance and Manager, Materials and Facilities shall review and sign-off the report.
16.3 Operational Reviews I h 16.3.1 Operational use shall be monitored through inspection and audit activities by approved Quality Assurance and Materials and Facilities procedures.
l 16.3.2 Findings shall be brought to the immediate attention of the plant management to:
16.3.2.1 Determine if use of the container should be terminated.
16.3.2.2 Assess the risk involved with proceeding.
l 16.3.2.3 Establish the corrective action and its implementation.
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_ 0F 2 QUALITY ASSURANCE RECORDS 17.1 Scope This section sets forth measures in effect at the CNFP for the preparation and maintenance of Quality Assurance Records.
It is the responsibility of the Quality Assurance and fiaterials and Facilities Sections to assure that adequate tests and inspection records are maintained to verify co;apliance with the provisions of this QA program.
17.2 General 17.2.1 Quality Assurance records in general include but are not necessarily limited to the following items: operating logs; results of reviews,
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inspections, tests, audits, and material analyses; qualification of personnel, procedures, and equipment; and other documentations such as drawings, specifications, procurement documents, calibration procedures and reports; nonconformance reports; and corrective action reports.
i 17.2.2 Quality Assurance records are identifiable and are retrievable from their respective storage locations within a reasonable time interval.
17.3 Requirements 17.3.1 Inspection and test reports, and other pertinent records shall be completed by personnel assigned theresponsibility to perform such inspections and tests. These reports will indicate the type of inspection or test, verification that the required test or inspect. ion was completed, the date, the results and acceptability of the results I
where applicable.
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PAGE OF 17.3.2 ' Inspection forms, test reports, and records shall indicate any deviation from requirements per Section 15 of this manual.
17.3.3 The CNFP shall retain design related records for the life of the ship-ping package and all other records are maintained for a minimum of two years.
17.3.4 After this period, the necessity for longer storage of the records shall be reviewed.
Final disposition of the records shall be con-tingent on concurrence that they are no longer required.
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I AUDITS 18.1 Scope This section sets forth the audit program (internal and supplier) in effect at the CHFP.
Internal audits are performed to verify compliance with the Quality Assurance Program and to determine the overall effective-ness of the program. Supplier audits are performed to monitor quality programs in effect at CNFP vendors while they are supplying material or components to current purchase orders. The audits shall be conducted by personnel who have experience or training in auditing using a checklist and/or other appropriate audit forms. It is the responsibility of the l
I CNFP Quality Assurance Section to administer the audit nrocram outlined below.
18.2 Requiremants Internal Audits 18.2.1 A comprehensive system of planned and documented audits of the Quality Assurar.ce program shall be conducted as a minimun at least twice each year at an interval of approximately six (6) months.
10.2.2 A team consisting of at least two (2) members shall perform the audit.
One (1) representative of the team shall be assigned from the Quality Assurance Section.
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op 18.2.2.1 For those activities relating specifically to the Quality Assurance Section, the member (s) cenaucting tne audit shall not have any direct responsibilities in Quality Assurance.
18.2.3 A follow-up shall be performed on corrective actions resulting from findings on previous audits.
18.2.3.1 The audit shall consist of observations of processes, products, and physical areas of the plant.
Interviews with cognizant supervisory personnel and a review of records and other documents shall be made as team l
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18.2.3.2 All findings resulting from the audit shall be reported individually on an internal audit finding report form.
l8.2.4 The completed audit forms along with a summary shall be submitted as a report.to the Manager, Quality Assurance.
Copies of this report shall also be distributed to the Manager, Materials and Facilities.
18.2.5 If there are findings the Supervisor, Data Evaluation shall I
request corrective action from each responsible representative notified with the target completion date.
18.2.6 The Supervisor, Data Evaluation shall review corrective action for timeliness and effectiveness noting that it is either satisfactory or unsatisfactory.
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op 4 18.2.7 The Supervisor, Data Evaluation shall transmit to the Manager, Quality Assurance all' completed internal audit reports for concurrence on corrective action taken.
18.2.8 If corrective action is satisfactory, the Manager, Quality Assurance shall return the internal audit finding (s) to the Data Evaluation Supervisor for filing.
If corrective action is unsatisfactory, a meeting shall be arranged with the applicable representative of the audited section and/or supervisor for the purpose of resolving differences in the proposed corrective action.
18.3 Supplier Audits 18.3.1 Quality Assurance is assigned the prime responsibility of developing a vendor audit schedule prior to release of a fabrication program. The schedule shall identify the audit team for the vendor, the audit fre-quency and suggested approximate audit date(s).
18.3.2 Once the audit schedule has been completed it shall be submitted to the Manager, Quality Assurance for approval.
18.3.3 An audit agenda shall be developed to satisfy those requirements which have been imposed on the vendor by QCR through the purchase order. However, hJditional items may be added to the agenda, i
e.g., follow-up on corrective actions from previous audits, quality problems the vendor may be having, etc. The agenda shall be submitted to the vendor prior to the audit.
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oF 4 18.3.4 Prior to and at the conclusion of each audit a meeting shall be held with vendor plant management. At the beginning of each audit the detail plan of how the audit will be accon.plished shall be presented to allow the vendor to schedule personnel and activities that will be involved in the audit. Once the audit has been completed, a post-audit critique shall be held where each finding of the audit is discussed along with recommended corrective action.
18.3.5 After the audit is completed, an audit report shall be prepared and submitted to the vendor for his information and action.
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18.3.6 The vendor shall be requested to reply to each finding indicating the corrective action he proposes to take with the target com-pletion date for the implementation of each corrective action.
18.3.7 If the corrective action is considered adequate the vendor will be notified accordingly and follow-up will be performed at the next regular scheduled audit to determine its effectiveness.
18.3.8 If the corrective action is deemed insufficient, further negotiations will be necessary with the vendor to achieve a mutually acceptable solution. The necessity for an immediate re-audit will be determined L
at this time.
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< > SHIPPING CONTAINER QUALITY ASSURANCE MANUAL GLOSSARY OF TERMS SNM-ll68:
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As used in this manual, the following terms shall mean:
ACCEPTANCE CRITERIA The limit, or limits, associated with established values, used to determine whether or not an item is satisfactory.
APPROVAL The act of endorsing or assign ng positive authorization, or both.
AS-BUILT DATA Documented data that describe the condition actually achieved in a product.
ASSEM3LY A combination of subassemblies or components or both fitted together to form a unit.
AUDIT l
l An activity to determine through investiga-tion, the adequacy of, and adherence to, established procedures, specifications, codes, and procurement document requirements, and the effectiveness of implementation.
CERTIFICATE OF CONFORMA! ICE A written statement, signed by a qualified party, certifying that items or services comply with specific requirements.
CERTIFICATION The action of determining, verifying, and attesting in writing to the quali-fications of personnel or material.
CHARACTERISTIC A physical, chemical, visual, functional, or other identifiable property of an item, I
process, or service.
CLEAULINESS A state of being clean in accordance with predetermined standards, and usually implies freedom from dirt, dust, rust, oil, or othar contaminating impurities.
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op 6 CORRECTIVE ACTI0ff Measures to identify and correct conditions adverse to quality or safety; for example, defective equipment, deviations to design specifications, and other non-compliances.
DESIGrl GROUP That section which helps to control, initiate,
.ecommend, revise, or approve various aspects of shipping container design, fabrication, or use.
DOCUMENT Any written or pictorial information des-scribing, defining, specifying, reporting, or certifying activities, requirements, procedures, or results.
DOCU.1ENTATI0ll A compilation of those documents concerning a specific function, activity, or project.
EXA:lINATION l
I An element of inspection consisting of investigation of materials, components, supplies, or services to determine confor-mance to those specified requirements which can be determined by such investigations.
Examination is usually non-destructive and includes visual, simple physical manipula-tion, gaging, measurement, and written documentation.
HANDLIllG An act of physically moving and/or lifting items by hand or mechanical means.
HOLD An action wherein a component, item, assembly, l
or part is withheld and segregated from l
further processing until a disposition has l
been defined and imposed.
l IllSPECTION A phase in which by means of examination, i
observation, or measurement determines the conformance of items, processed, or services to predetermined requirements.
Inspection may involve the use of special equipment tools, procedures, or documentation.
It is performed by qualified personnel whose I
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op 6 duties include verification of quality related activities and who is independent of the activity being verified.
ITEM Any level of unit assembly, including system, subsystem, subassembly, component, or material.
MATERIAL A substance or combination of substances used to form pieces, parts, components, items, etc.
NON-CONFORfMNCE A deficiency in characteristic, documenta-tion, performance of procedure which renders the quality of an item unact.eptable or in-determinate. Examples of r.on-conformances include: physical defects., incorrect or inadequate documentation; or deviation from design standards, prescribed processing, in-l I
spection or test oracedures, and procurement document requirements.
PART An item which has work performed on it and which is attached to, and becomes an element of a component.
PROCEDURE A document which specifies instructions for performance of a particular task.
It includes methods to be employed, description of equipment or material to be used, sequence of operations, etc.
PROCESS One or more operations, methods, functions, procedures, or other specified actions, which result in the desired end item or result.
PROCUREMENT DOCUMENT A contracturally binding document, includ-ing attachments, identifying the requirements which items or services must meet prior to acceptance. Also includes purchase requisitions.
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PAGE 4 0F 6 QUALIFICATI0ii A demonstration of those characteristics (PERS0tif4EL) or abilities of an individual, gained through training and/or experience, that enable him to perform specific functions.
QUALIFIED EQUIPMEtiT Equipment which has been evaluated by sufficient testing to assure performance within specified parameters.
QUALIFIED PARTY OR A person or organization competent and I?IDIVIJUAL recognized as knowledgeable to perform certain functions.
QUALIFIED PROCEDURE A procedure which incorporates all applicable code and standard requirements, manufacturing parameters and engineering specifications, and which has been proven adequate for the intended purpose.
I QUALITY The properties or characteristics, con-stituting those requisites of specifications, codes, standards, industrial practices,
other recognized methods and/or acceptance criteria, by which an item is judged.
QUALITY ASSURAfiCE Those quality assurance actions which pro-vide a means to control the characteristics of an item, proc 2ss, or facility to established requirements.
REJECT A disposition which may be imposed on a non-conforming item providing for its l
withdrawal and isolation from further processing pending an evaluation to l
repair, rework, use-as-is, or scrap.
REPAIrt The process of restoring a non-conforming characteristic to a condition such that the capability of an item to function reliably and safely is unimpaired, even though the item still may not conform to the original requirement in every aspect.
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op 6 REWORK The process by which a non-conforming item is made to conform to a prior specified requirement by completion, remachining, reassembling, or other remedial means.
(Cutting off excess metal is rework; welding on an extension is repair.)
SCRAP A disposition which may be imposed upon a non-conforming item when it has been established that the discrepancy renders the item unfit for its intended use and it is not economically or othent!se feasible to repair or rework it. Scrip may also be excess material, or damaged material, remain-ing from fabrication operations which is un-suitable for further use.
SHIPPIllG CONTAlilER That which is used to contain radioactive
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material for either off-site shipments, or in-house movement as it applies to the CilFP operations (i.e., unirradiated low enriched fuel assertlies, unirradiated scrap U0,
contaminated material, or sealed S/y ebitting sources used for calibration or analytical purposes).
SOURCE IflSPECTI0tl A review, observation, inspection, or in-dication for the purpose of verifying that an action has been accomplished as specified at the location of procurement or manufacture.
SPECIFICATI0t1 A concise statement of a set of requirements to be satisfied by a product, a material, or process indicating, whenever appropriate, the procedure by means of which it may be determined whether the requirements given are satisfied.
SUPPLIER Any organization under contract for furnish-ing items or services.
It concludes the terms vendor, contractor, subcontractor, fabricator, and subtier levels of these where appropriate.
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PAGE OF TRACEABILITY Pertains to bulk and unit traceability as it applies to parts, materials, or com-ponents.
It is a program used to control and identify materials, parts, or com-ponen ts. Typically, unit traceability
. utilizes concepts as unique serial numbers for each item. Bulk traceability includes those materials fabricated from common material. steel pla te, sheet, rods, etc.
USE-AS -IS A dispositio^n' which may be imposed upon non-conforming items when it has been established that the discrepancy does not affect. the intended use and that the item will conform to functional
~requirements.
VERIFICATION The act of confirming, substantiating, g )
and/or assuring that an action has been performed or a condition achieved in conformance with specified requirements.
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