ML20035E714
| ML20035E714 | |
| Person / Time | |
|---|---|
| Site: | 07100231 |
| Issue date: | 04/12/1993 |
| From: | Cole M, Langan D, Paquin P GENERAL NUCLEAR SYSTEMS, INC. |
| To: | |
| Shared Package | |
| ML20035E712 | List: |
| References | |
| NUDOCS 9304190135 | |
| Download: ML20035E714 (96) | |
Text
-.
GNSI QUALITY ASSURANCE PLAN PROJECT:
MANUFACTURING OF U.S.
NUCLEAR REGULATORY COMMISSION LICENSED DRY STORAGE AND TRANSPORT CASK SYSTEMS POR RADIOACTIVE MATERIALS (LICENSED PRODUCTS) i REVISION NO.
4 DATE April 12, 1993 s
BECURITY STATUS NON-PROPRIETARY PREPARED BY b 7"[8 f
D. L. Langan Date Director of Quality Assurance REVIEWED BY
<d 4
8 fD-P.L. Paquin
/)
Data General Managirf 7
APPROVED BY
//
Date /
i M. J.JCole President l
l ik &
d i
a i
9304190135 930409 PDR ADOCK 07100231 C
I GNSI QUALITY ASSURANCE PLAN (QA PLAN)
INDEX
1.0 INTRODUCTION
1 1.1 SCOPE 1
1.2 APPLICABILITY 1
1.3 RESPONSIBILITY 2
2.0 GLOSSARY OF TERMS 3
3.0 REFERENCED DOCUMENTS 6
3.1 CODE OF FEDERAL REGULATIONS AND GUIDES 6
3.2 TECHNICAL CODES AND STANDARDS 6
3.3 MATRIX OF QUALITY ASSURANCE REQUIREMENTS 6
4.0 GENERAL REQUIREMENTS AND PREREQUISITE.
6 5.0 QUALITY ASSURANCE.
8 5.1 PURCHASER 8
5.2 GENERAL NUCLEAR SYSTEMS, INC. (GNSI) 8 5.3 GESELLSCHAFT FOR NUKLEAR SERVICE MBH (GNS),
GERMANY 9
5.4 CHEM-NUCLEAR SYSTEMS, INC. (CNSI), USA.
10 6.0 BUNDESANSTALT FOR MATERIALPRUFUNG (BAM) 11 7.0 NON-COMPLIANCES AND DEFECTS (10 CFR PART 21) 12 i
8.0 QUALITY ASSURANCE RECORDS 13
9.0 CONCLUSION
15 ATTACHMENT I - MATRIX OF QUALITY ASSURANCE REQUIREMENTS ATTACHMENT II - TYPICAL WITNESS AND HOLD POINTS FIGURE 1 - ORGANIZATIONAL RELATIONSHIPS FIGURE 2 - ORGANIZATIONAL CHART l
APPENDIX A - CHEM-NUCLEAR
- SYSTEMS, INC (CNSI)
QUALITY ASSURANCE PROGRAM APPENDIX B - GESELLSCHAFT FOR NUKLEAR - SERVICE MBH (GNS)
QUALITY ASSURANCE PLAN FOR GNSI CASTOR CASKS LICENSED BY THE UNITED STATES NUCLEAR REGULATORY COMMISSION (QAP)
GNSI QA PLAN - REV. 4 page i
t i
l GNSI QUALITY ASSURANCE PLAN j
(QAP)
1.0 INTRODUCTION
l General Nuclear Systems, Inc. (GNSI) is a joint venture company formed l
in 1986 by Chem-Nuclear Systems, Inc. (CNSI) of Columbia, South Carolina and Gesellschaft fur Nuklear-Service mbH (GNS) of Essen, Germany.
The organization is based in Columbia, South Carolina and is involved in the supply of casks for the shipment and storage of nuclear material and in the management of high level wastes.
t 1.1 SCOPE 1.1.1 This Quality Assurance Plan provides general l
requirements and guidance for the establishment and execution of the Quality Assurance Program for manufacturing US NRC licensed Dry Storage and Transport Cask Systems for radioactive materials.
Items and activities which are important to safety shall meet the i
requirements of 10 CFR 71 and 10 CFR 72.
Those items and activities designated as "important to safety" in i
l this QA Plan shall also mean " safety related" when i
applied to the 10 CFR 50 requirements.
The requirements l
and guidance pertain to activities including procuring, l
fabricating, handling, shipping, storing, cleaning, i
inspecting, and testing which affect the quality of i
nuclear items that are important to safety.
1.2 APPLICABILITY 1.2.1 The requirements of this QA Plan apply to all activities that affect the quality of US NRC licensed Dry Storage j
and Transport Cask Systems for radioactive materials j
(licensed products).
Activities include performing the l
functions of attaining quality objectives and the functions of assuring that an appropriate quality assurance program is established and of verifying that activities affecting quality have been correctly performed.
1.2.2 This QA Plan is applicable to all items and activities
[
which are "important to safety" per 10 CFR 71 and 10 CFR 72 or " safety related" per 10 CFR 50.
These items and activities shall be specified in Safety Analysis Reports or any licensing documents reviewed and approved by the US NRC.
1.2.3 This QA Plan is not applicable for repair, maintenance, and modification of Dry Storage and Transport Cask Systems after they have been accepted by the Purchaser.
GNSI QA PLAN - REV. 4 Page 1 I
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1.3 RESPONSIBILITY 1.3.1 General Nuclear Systems, Inc. (GNSI) is responsible for meeting the requirements of this QA Plan.
The requirements of this QA Plan shall be implemented in accordance with CNSI or GNS written approved procedures, instructions and drawings.
l The following GNSI positions are fulfilled by Chem-Nuclear Systems, Inc. personnel:
President 1
Vice President Engineering General Manager Project Manager Director of Quality Assurance GNSI shall provide quality assurance overview of activities covered by this QA Plan.
This overview shall l
be performed by CNSI personnel in accordance with the CNSI Quality Assurance Program.
GNSI shall be responsible for being the liaison with regulatory agencies, purchasers, and other organizations involved in the manufacture of Dry Storage and Transport Casks.
Figure 1 shows the GNSI, CNSI, GNS, and other key relationships.
1.3.2 GNSI has delegated to Gesellschaft fur Nuklear-Service mbH (GNS), in Germany, the responsibility for activities
[
4 in Europe.
GNS shall perform all work in accordance with this QA Plan.
1.3.3 GNSI has delegated to CNSI, in Columbia, South Carolina, the responsibility for activities performed in North America.
CNSI shall perform all work in accordance with this QA Plan.
CNSI is also responsible for record retention and document distribution for GNSI.
{
1.3.4 The Bundesanstalt fur Materialforschung_und-prufung l
(BAM) or their agents monitor GNS and GNS supplier j
manufacturing activities in Europe as described in Section 6.0 of this QA Plan.
j 1.3.5'In addition to the activities performed by BAM for manufacturing by GNS, GNSI will assure that manufacturing activities conform to the requirements of the US NRC approved design and this QA Plan.
Specific GNSI activities are described in Section 5.2 1.3.6 The US NRC regulates and has the authority to inspect activities that are important to safety to assure that the US regulations are being complied with and this QA Plan is properly implemented.
Page 2 GNSI QA PLAN - REV. 4
1.3.7 Other specific interface control and responsibilities of organizations shown in the Functional Organization Chart (Figure 2) are defined and documented in the various j
sections of this QA Plan.
2.0 GLOSSARY OF TERMS 2.1 ACCEPTANCE CRITERIA Specified limits placed on characteristics of an item, i
l process, or service defined in codes, standards, or other l
requirement documents.
2.2 AUDIT l
A documented activity performed in accordance with written I
procedure or checklist to verify, by examination and l
evaluation of objective evidence, that selected elements of the quality program have been developed, documented, and implemented in accordance with specified requirements.
An audit does not include surveillance or inspection for the purpose of process control or acceptance of materials or items.
2.3 CERTIFICATE OF CONFORMANCE A document signed by an authorized individual certifying the degree to which items or services meet specified requirements.
2.4 CERTIFICATION The act of determining, verifying, and attesting in writing to the qualifications of personnel, processes, procedures, or items in accordance with specified requirements.
t 2.5 COMPETENT AUTHORITY Any national authority designated to inspect and enforce the applicable regulations.
2.6 CONDITION ADVERSE TO QUALITY An all-inclusive term used in reference to any of the following:
failures, malfunctions, deviations, deficiencies, defective items, and nonconformances.
A significant condition adverse to quality is one which, if uncorrected, could have a serious effect on safety or operability.
2.7 CORRECTIVE ACTION Action undertaken to identify the cause of a deficiency, discrepancy, or nonconformity, to correct a condition adverse to quality and prevent recurrence.
GNSI QA PLAN - REV. 4 Page 3
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2.8 DEVIATION A departure from specified requirements.
i 2.9 DOCUMENT Any written or pictorial information describing, defining, specifying, reporting, or certifying activities, requirements, procedures, or results.
A document is not considered to be a Quality Assurance Record until it satisfies the definition of a Quality Assurance Record as defined in this QA Plan.
2.10 INSPECTOR A qualified and authorized person wno performs inspection activities to verify conformance to specific requirements.
2.11 INSPECTION Examination or measurement to verify whether an item or activity conforms to specified requirements.
2.12 ITEM An all-inclusive term used in place of any of the following:
appurtenance, assembly, component, equipment, material, module, part, structure, subassembly, subsystem, system, or units.
2.13 NONCONFORMANCE A deficiency in characteristic, documentation, or procedure which renders the quality of an item or activity unacceptable or indeterminate.
2.14 OBJECTIVE EVIDENCE Any documented statement of fact, other information, or record, either quantitative or qualitative, pertaining to the quality of an item or activity, based on observations, measurements, or tests which can be verified.
2.15 PROCEDURE A step-by-step instruction for carrying out processes, inspection, control, examination, and test.
2.16 PURCHASER A responsible organization, party, or person authorized by the US NRC to use the GNSI Dry Storage and Transport Cask Systems.
Page 4 GNSI QA PLAN - REV. 4 i
2.17 QUALITY ASSURANCE (QA)
All those planned and systematic actions necessary to provide adequate confidence that all items designed and constructed are in accordance with the Design Specification and contract requirements.
Quality Assurance includes Quality Control.
2.18 QUALITY ASSURANCE OVERVIEW I
The combination of QA audits, surveillances, inspections and document reviews that provide assurance of compliance with established requirements.
2.19 QUALITY ASSURANCE RECORD A completed document that furnishes evidence of the quality of items and/or activities affecting quality.
2.20 REVIEW Examine in detail.
Reviewing of documents shall require l
signing or stamping and dating by the authorized reviewer, i
either on the document (s) or on records traceable to the document (s).
L 2.21 SUPPLIER 1
Any individual or organization who furnishes items or services in accordance with a procurement document.
An all-inclusive term used in place of any of the following:
vendor, seller, contractor, subcontractor, fabricator, consultant, and subtier i
levels.
I l
2.22 SURVEILLANCE The act of monitoring or observing to verify whether a manufacturing step or activity conforms to prescribed requirements.
2.23 TESTING An element of verification for the determination of the capability of an item to meet specified requirements by subjecting the item to a set of physical, chemical, environmental, or operating conditions.
2.24 VERIFICATION An act of confirming or assuring that an activity or condition has been satisfactorily performed or created in compliance with specified requirements.
As used herein, verificatica l
requires signing or sign-off.
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GNSI QA PLAN - REV. 4 Page 5 i
3.0 REFERENCED DOCUMENTS 3.1 CODE OF FEDERAL REGULATIONS AND GUIDES A.
Title 10, Part 2 (10 CFR 2)
Appendix C B.
Title 10, Part 21 (10 CFR 21)
C.
Title 10, Part 50 (10 CFR 50) Appendix B D.
Title 10, Part 71 (10 CFR 71) Subpart H E.
Title 10, Part 72 (10 CFR 72) Subpart G F.
3.2 TECHNICAL CODES AND STANDARDS 3.2.1 American National Standard Institute /American Society of Mechanical Engineers ANSI /ASME NQA-1-1989 Quality Assurance Requirements for Nuclear Power Plants.
3.2.2 Standards of Deutsches Institut fur Normung e.V.
(German Institute of Standardization) DIN - Applicable Technical Standards which are specified in the Topical Safety l
Analysis Report or any licensing documents reviewed and approved by the NRC for a particular design.
3.2.3 Applicable ANSI, ASTM, and ASME standards as specified in Topical Safety Analysis Report.
3.2.4 Applicable alternate standards to those specified in the Topical Safety Analysis Report or any licensing documents reviewed and approved by the NRC may be used if evaluated to show that such standards are equivalent standards.
This evaluation shall be documented and maintained as a record.
3.3 MATRIX OF QUALITY ASSURANCE REQUIREMENTS 3.3.1 Matrix of Quality Assurance Requirements (Attachment I) is developed to show the main elements of Quality Assurance Programs and the relationships between the above Federal Regulations, Technical Codes, and Standards.
i 4.0 GENERAL REQUIREMENTS AND PREREQUISITES 4.1 This QA Plan describes all quality assurance functions to be implemented to provide adequate confidence that manufacturing is performed in accordance with the applicable Code of Federal Regulations, technical codes, and engineering standards.
4.2 The basic responsibility for compliance and quality assurance rests with GNSI and its suppliers.
The management of all organizations involved shall foster a quality assurance and compliance awareness throughout their respective organization.
It is therefore essential that every individual in their j
Page 6 GNSI QA PLAN - REV. 4 l
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organizntion be aware of and trained in their duties and responsibilities within their Quality Assurance Program and I
this QA Plan at all stages of procurement, fabrication, handling, shipping, storage, cleaning, inspection, testing, documentation, and certification.
4.3 GNSI and its suppliers shall operace in accordance with this QA Plan, Purchaser's Procurement Documents, and applicable licensing requirements.
4.4 ADMINISTRATION AND DISTRIBUTION OF QA Plan 4.4.1 GNSI is responsible for the administration of this QA Plan.
GNSI shall cooperate with Purchasers, NRC, BAM, their designated agents, consultants, and representatives in the execution of the overall project.
Project relationships are established and shown in Figure 1 - Organizational Relationships.
4.4.2 A General Manager has been designated by GNSI who is responsible for ensuring the effective implementation of this QA Plan.
4.4.3 A Project Manager has been designated by GNSI for the project who will be responsible for coordinating the i
project and acts as liaison between GNSI, CNSI, GNS, Purchasers, and other organizations.
4.4.4 A Director of Quality Assurance has been designated by
{
GNSI who is responsible for ensuring effective
(
implementation of the quality assurance requirements imposed on GNSI and its suppliers.
4.4.5 The NRC QA Plan Acceptance Lrtter, master copy, and all previous revisions of the QA Plan and QA Topical Report shall be maintained and controlled by GNSI.
Controlled copies with assigned control numbers of the QA Plan will be issued to the following, as a minimum, and their issuance shall be recorded and maintained by the Director of QA:
l A. Purchaser B. GNS C.
BAM D. USNRC E. CNSI l
4.5 CHANGES TO QA Plan 4.5.1 Changes to this QA Plan may be initiated by the General Manager, Project Manager, Director of QA, or Purchasers.
Changes that do not reduce the commitments in the previous QA Plan revision shall be submitted to the NRC by GNSI at least annually.
QA Plan changes that reduce GNSI QA PLAN - REV. 4 Page 7
l l
previous commitments shall be submitted to the NRC and l
NRC approval received prior to implementation.
The Director of QA shall evaluate the QA Plan changes and determine whether the change is a reduction in commitment.
4.5.2 Approved QA Plan changes shall be controlled and distributed in the same manner as described in Paragraph 4.4.5.
5.0 QUALITY ASSURANCE 5.1 PURCHASER 5.1.1 The purchaser has the authority to perform, at their discretion, Inspections, Surveillance, and other Verification Programs (Witness Points and Hold Points) to assure quality.
5.1.2 The purchaser has the authority to review documentation and Quality Assurance Records supplied by GNSI prior to final acceptance.
5.2 GENERAL NUCLEAR SYSTEMS, INC. (GNSI) 5.2.1 GNSI has primary responsibility for providing Quality Assurance overview of the activities addressed in the QA Plan through audits, surveillances and reviews.
The Quality Assurance overview will be conducted by CNSI Personnel in accordance with the CNSI Quality Assurance Program (Appendix A).
5.2.2 GNSI will perform the following quality assurance activities:
A. Review and accept the GNS Quality Assurance Plan applicable to the USNRC Licensed Casks for GNSI.
B. Perform internal quality assurance audits of GNS and CNSI annually.
Internal audits shall be performed by personnel not directly responsible for the activity being audited.
C.
Establish and execute, at their discretion, surveillance points, witness points, and hold points during the manufacturing process of Dry Storage and Transportation Cask Systems.
Surveillance, hold and witness points will be established by review of manufacturing plans or other work controlling documents and shall be communicated to the supplier in writing.
D. Review all fabrication drawings prepared for or by GNS to assure conformance with the requirements of Pcge 8 GNSI QA PLAN - REV. 4
i the USNRC approved design and purchaser specifications.
E. Assure initiation of nonconformance reports for any l
deviations to Purchaser's specifications.
j F. Review and concur with dispositions of nonconformance reports prior to forwarding to Purchaser.
G.
Perform review of Quality Assurance records associated with the manufacturing of Dry Storage and Transportation Cask Systems.
H. Issue Certificates of Conformance.
I. Maintain record copies of lifetime records.
l 5.3 GESELLSCHAFT FOR NUKLEAR - SERVICE MBH (GNS), GERMANY l
5.3.1 All cask activities performed by'GNS for GNSI shall be in accordance with their established Quality Assurance Plan (Appendix B).
i l
5.3.2 GNS is responsible for selecting, qualifying,.and i
auditing their suppliers of subcontracted services and items.
Suppliers must.have an established and documented Quality Assurance System that satisfies the applicable requirements of References 3.1 C, D and E, i
and is consistent with the requirements of'the GNS Quality Assurance Plan.
GNS Suppliers' established Quality Assurance System shaS1 include the following criteria as applicable:
A. Organization I
B. Quality Assurance Program C. Design Control D. Procurement Document Control
)
i E. Instructions, Procedures, and Drawings
[
i F. Document Control G.
Control of Purchased Material, Equipment, and Services H. Identification and control of Materials, Parts, and Components l
I. Control of Special Processes J.
Inspection i
i GNSI QA PLAN - REV. 4 Page 9 i
i e.
,-a
~
l K. Test Control L.
Control of Measuring and Test Equipment M. Handling, Storage, and Shipping N. Inspection, Test, and Operating Status i
O. Nonconforming Materials, Parts, or Components j
P. Corrective Action Q. Quality Assurance Records R. Audits 5.3.3 GNSI, BAM, USNRC, and Purchasers may, at their discretion, audit GNS suppliers of subcontract services and items.
5.4 CHEM-NUCLEAR SYSTEMS, INC. (CNSI), USA 5.4.1 CNSI is responsible for activities performed in North America and shall perform all work in accordance with their established Quality Assurance Program
~
(Appendix A).
7 5.4.2 CNSI is responsible for selecting, qualifying, and r
auditing their suppliers of subcontracted services and-
[
items.
Suppliers must have an established and documented Quality Assurance System that satisfies the j
applicable requirements of References 3.1 C, D, and E, and is consistent with the requirements of the CNSI Quality Assurance Program.
CNSI Suppliers' established Quality Assurance System shall include the following criteria as applicable:
A. Organization l
B. Quality Assurance Program C. Design Control D. Procurement Document Control E. Instructions, Procedures, and Drawings F. Document Control G. Control of Purchased Material, Equipment, and i
Services l
H. Identification and control of Materials, Parts, and Components Page 10 GNSI QA PLAN - REV. 4 1
I.
Control of Special Processes J. Inspection K. Test Control L. Control of Measuring and Test Equipment M. Handling, Storage, and Shipping N. Inspection, Test, and Operating Status O. Nonconforming Materials, Parts, or Components P. Corrective Action Q. Quality Assurance Records R. Audits 5.4.3 GNSI, USNRC, and Purchasers may, at their discretion, audit CNSI suppliers of subcontract services and items.
6.0 BUNDESANSTALT FOR MATERIALPRUFUNG (BAM)
Due to the unique nature of fabricating USNRC licensed spent fuel storage and shipping components in Europe, GNSI enhances its overview through additional independent activities to assure quality.
GNSI, through GNS, employs the services of the BAM to assure that manufacturing activities performed in Europe conform to the requirements of this QA Plan.
BAM provides assurance that manufacturing activities in Europe conform to the requirements of the US NRC approved desi provide this assurance, gn and GNS Quality Assurance Program.
To BAM or their agent performs the following activities:
6.1 Inspections - The following inspection activities are performed:
t 6.1.1.
Inspection Planninu - Inspection planning is to assure that the stipulations of the authorization for manufacturing are maintained by means of suitable fabrication and inspection plans.
The plans should be documented using BAM Standard Form, Fertigungs -
u.PrQffolgeplan (FPP - Fabrication and Test Plan) and shall be reviewed by BAM or their agent prior to use.
The review will be based upon the latest revision of drawings and specifications as stated in the US NRC approved Cask Safety Analysis Report as well as any specifications required by the GNS procurement
(
documents.
The BAM shall assign their Witness and Hold Points in the FPP.
The following information must be included or referenced in this plan:
j GNSI QA PLAN - REV. 4 Page 11
Specification of work and inspection in the form of work and test instructions, including qualitative and quantitative acceptance criteria.
Specification of data to be maintained in the form of technical drawings, material specification, procedures, instructions, etc.
Person (s) responsible for performing, witnessing, or certifying the activity.
Type of verification and documentation required.
6.1.2.
In-Process Inspection - In-Process Inspections must be performed in accordance with the requirements stipulated in the FPP.
Inspections shall be determined by the importance of the item or feature influenced by the manufacturing process.
Test results must be verified against procedures, drawings, applicable European specifications, and i
recorded in the FPP.
The activities shown in Attachment II are typical Witness and Hold Points that may be inspected, witnessed, and verified by BAM or their agent during the manufacturing process.
6.1.3.
Final Inspection - After manufacturing, each completed item which is important to safety will be inspected prior to final acceptance and use.
This inspection may be performed by BAM or their agent.
Part of the final inspection shall be verification of documents as to completeness and accuracy.
6.2 Certificate of Conformance - After final inspection, documentation review, and evaluation of test results, BAM will issue a Certificate of Conformance.
This Certificate will confirm that the material, parts, or completed component or cask system was manufactured in accordance with the requirements of the FPP.
The Certificate of Conformance shall list all deviations to the drawings or European specifications.
The Certificate of Conformance will be a part of the Final Documentation / Quality Assurance Record.
6.3 Enforcement - BAM, acting as the Competent Authority in l
Germany, will inform the USNRC in writing of any information l
which could result in enforcement action under the German Federal Law for Transport of Dangerous Goods.
7.0 NON-COMPLIANCES AND DEFECTS (10 CFR PART 21) 7.1 GNSI and its suppliers shall comply with the requirements of
{
10 CFR Part 21 and shall advise the NRC immediately of any non-compliance or defects.
Any person employed by GNSI and its suppliers obtaining information which reasonably indicates Page 12 GNSI QA PLAN - REV. 4
that a product or activity or basic component supplied by them fails to comply with the Atomic Energy Act of 1954 as amended, or any applicable rule, regulation, order, or license of the NRC relating to substantial safety hazards, or contains defects which would create a substantial safety hazard as defined by regulations which the NRC shall promulgate, shall immediately notify their management of such failure or defect for proper evaluation and reporting to the NRC in accordance with 10 CFR Part 21.
7.2 The GNSI General Manager shall be the responsible official for reporting non-compliances or defects to the NRC.
8.0 QUALITY ASSURANCE RECORDS 8.1 Records providing documentary evidence of the quality of the item and activities affecting quality shall be maintained throughout the life of the item by GNSI.
GNSI may delegate the maintenance of Quality Assurance Records to the Purchaser provided that delegation is documented and approved by both organizations.
8.2 Quality Assurance Records will be submitted by suppliers to GNSI for proper distribution and maintenance.
8.2.1 The General Manager shall be responsible for the distribution of Quality Assurance Records.
8.2.2 The Director of Quality Assurance is responsible for the maintenance of Quality Assurance Records.
8.3 Quality Assurance Records shall be made available by GNSI and its suppliers to NRC, BAM, Purchasers, their designated agents, experts, and consultants.
8.4 The QA Records identified below, generated by GNS, CNSI, or their suppliers, shall be retained by GNSI.
8.4.1 The QA Records listed below are to be submitted to GNSI by GNS for European Fabricated Casks, and shall be retained as lifetime records:
A. Records to be provided to the customer and submitted to GNSI for retention upon Cask delivery:
1.
Fabrication and Test Sequence Plans (FPP) 2.
Dimensional Examination (Gauging) Reports 3.
Nondestructive Examination Reports (PT, MT, UT, Visual) 4.
Heat Treatment Records 5.
Material Test Reports and Certifications o Chemical GNSI QA PLAN - REV. 4 Page 13 i
o Mechanical (Tensile, Elongation, Fracture l
Toughness, NDTT) l o Weld Rod, Wire and Flux o Shielding Ma.terials o Poison Materials o Expendables Contacting Stainless Steel (not applicable if approved cleaning program is implemented) 6.
Test Reports o Painting (Film Thickness, Porosity Test) o Leak Test 7.
Pressure Switch Functional Test (Calibration) 8.
Repair Records j
9.
Supplier Nonconformance Reports / Internal l
Deviation Reports 10.
GNS Certificate of Conformance 11.
BAM Certificate of Conformance 12.
Design Verifications (Shielding, Poison) i 13.
As-Built Drawings B. Records to be submitted to GNSI for retention upon Cask delivery:
1.
Audit Records (GNS) o Internal o Supplier 2.
Procedures o NDE (UT, PT, MT, Visual / Dimensional) o Leak Test i
o Handling, Storage, Packaging and Shipping l
Cleaning, Surface Preparation and Painting o
o Shielding Design Verification o Poison Design Verification o Welding and Weld Qualification o Repair 3.
Fabrication and Material Specifications 4.
Parts Lists 5.
Statements of Personnel Qualification:
o Audit Personnel Personnel Reviewing / Approving FPP's (does not o
include BAM/TDV Personnel) o Leak Testing o Welding o Painting o NDE/ Visual 6.
Certificates of Calibration o UT Equipment o MT Equipment o Leak Test Equipment o Measuring Equipment Painting (Film Thickness Gauge) o 7.
Approved Vendors List 8.
Engineering and Fabrication Drawings 9.
Purchase Orders (Materials)
Page 14 GNSI QA PLAN - REV. 4
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8.4.2 The following Records, generated by GNSI, CNSI, or CNSI's suppliers, shall be retained by GNSI as QA Records in accordance with the CNSI QA Program.
1.
Certificates of Conformance/ Compliance-2.
Index to the QA Records 3.
As-Built Drawings 4.
Visual and Dimensional Examination Reports S.
Certified Material Test Reports-(CNTR), Physical and l
Chemical 6.
Welding Procedures and Qualification Records 7.
Heat Treatment Procedures and Reports 8.
Non-Destructive Examination Procedures and Reports 9.
Repair Procedures and Repair Records l
- 10. Test Procedures and Reports i
- 11. Nonconformances and Corrective Actions
- 12. Qualification Records for Inspection, Test (NDE),
and Audit Personnel 13.-Calibration Records
- 14. Audit Records (GNSI, CNSI)
- 15. Fabrication and Material Specifications
- 16. Topical Safety Analysis Report
- 17. Approved Vendors List
- 18. Parts Lists I
- 19. Purchase Orders (GNS and CNSI)
- 20. Repair Records'
- 21. Design Verification (Shielding / Poison) 8.5 Corrections to QA Records shall be annotated with initials (or stamp) and date by the individual (s) authorized to make the correction.
i
9.0 CONCLUSION
The quality assurance requirements specified in this QA Plan will provide adequate confidence that manufacturing activities conform to US NRC regulations.
t r
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ATTACHMENT I MATRIX OF QUALITY ASSURANCE REQUIREMENTS 10 CFR 50 QUALITY CRITERIA APPENDIX B 10 CFR 71 ANSI SUBPART H ASME I
10 CFR 72 NQA-1 1989 l
SUBPART G i
organization I
71.103 BR-1 S-IS-1
[
t Quality Assurance Program II 71.105 BR-2 I
S-2S-1,2,3 k
Design Control III
'71.107 BR-3 S-3S-1 t
Procurement Document Control IV 71.109 BR-4 S-4S-1 j
Instructions, Procedures, &
V 71.111 BR-5 Drawings Document control VI 71.113 BR-6 S-65-1 Control of Purchased VII 71.115 BR-7 Material, Equipment, &
S-7S-1 i
Services r
Identification & Control of VIII 71.117 BR-8 l
Materials, Parts, &
S-8S-1 k
Components i
i control of Special Processes IX 71.119 BR-9 6
S-9S-1 i
Inspection X
71.121 BR-10 S-10S-1 Test control XI 71.123 BR-11 S-11S-1 i
control of Measuring & Test XII 71.125 BR-12 Equipment S-12S-1 i
Handling, Storage,'& Shipping XIII 71.127 BR-13 S-135-1 Inspection, Test, & Operating XIV 71.129 BR-14 Status Non-Conforming Materials, XV 71.131 BR-15 Parts, or components S-15S-1 Corrective Action XVI 71.133 BR-16 Quality Assurance Records XVII
- 77. 135 BR-17 S-17S-1 Audits XVIII 71.137 BR-18 S-185 GNSI QA PLAN - REV. 4
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ATTACHMENT II TYPICAL WITNESS AND HOLD POINTS Activity Item
PV 11 Secondary Lid (S)
PV 11 P and S Bolts PV 13 Trunnion Bolts PV 13 Identification (Stamping Cask Body WB O2 or BS 04 and re-stamping during cutting / machining) of Trunnions WB 12 or BS 06 materials and test Radionox Plates for Fuel BS 05 specimens and Examination Baskets of Mechanical Properties including Spectroscopic and Primary Lid WB 20 or BS 06 Boron content Examination of Radionox Plates for Fuel Secondary Lid WB 20 or BS 06 Basket.
P & S Bolts WB 14 or BS 06 Trunnion Bolts WB 13 or BS 07 Dimensional Examination and Cask Body A500.11-02/3 Final Identification check.
Trunnions C 500.11-12 Primary Lid A 500.11-20 Secondary Lid A 500.11-55/2 P & S Bolts MUN 601.11/2 Trunnion Bolts MUN 601.11/2 Surface Cracks Examination Cask Body PV 20 Trunnions PV 22 Primary Lid PV 21 Secondary Lid PV 21 P & S Bolts PV 23 or PV 26 Trunnion Bolts PV 23 or PV 26 Leak Test Completed Cask (Primary PV 32 and Secondary Lids &
Procedures, Drawings, Material Specifications, etc.
GNSI QA PLAN - REV. 4
FIGURE 1 ORGANIZATIONAL RELATIONSIIIPS NRC PURCIIASER NOR17f AMERICAN FABRICATION gygg ggy ACT11rT11ES l
7_ a CNSI GNS EUROPEAN FABRICATION AC11VITIES SUPPLIERS SUPPLIERS L._.
L GNSI QA PLAN - REV. 4
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FIGURE 2 ORGANIZATIONAL CIIART GNSI PRESIDENT VICE PRESIDENT DIRECTOR ENGINEERING QUALITY ASSURANCE GENERAL MANAGER PROJECT MANAGER PROJECT MANAGER GNS CNSI I
FABRICATION QUALITY ASSURANCE FABRICATION QUALITY ASSURANCE l
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6._________________________________________2____________.,
GNSI QA PLAN - REV. 4
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i APPENDIX A P
CHEM-NUCLEAR SYSTEMS, INC (CNSI)
QUALITY ASSURANCE PROGRAM
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CHEM-NUCLEAR SYSTEMS, INC (CNSI) l QUALITY ASSURANCE PROGRAM i
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DESC7;tPTION DATE APPROVED
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IN ADDITION TO ALL APPLICABLE CNSI DOClhENT CONTROL CNSI SAFETY REVIEW REQUIRE 4ENTS, AW PROPOSED CHANGE 70 QA-AD-001 REQUIRES FORMAL US NRC APPROVAL IN ACCORDANCE WITH BOARD APP" VAL
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10 CFR 71 OR A SIGNED STATB4ENT BY THE DIRECTOR, BY.
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1 CNSI QA UPON THE CHANGE REQUEST (SUBSEQUEVT TO REVISION F) hMICH JUSTIFIES THAT SUCH APPROVAL IS DATE MJ Eft M ANTED.
REVIStON $TATUS
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5 6
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9 10 11 12-13 14 15 16 8
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SHEET REv.
1 PREPARED DATE gpg k,,,g, CHEM - NUCLEAR SYSTEMS, INC.
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TITLE ravMA- 'Vns ENGINEE 3,a QUALITY ASSURANCE PROGRAM IW6 h Ghlw
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REVIS10NS 1
Rev.
Description Revised Approved A
Revised per Change Request QA-AD-001-01
- d. M L.E.Reynolds Change Request approved by SRB 8/30/79 f/V/77 9/5/79 A-B Revised per Change Request QA-AD-001-02
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Change Request approved: by SRB 2/18/82 z.//1/8L
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C Revised per Change Request QA-AD-001-03 Change Request Approved by SRB 8/8/83 9-93-93 ppgg 6M'vD63Difb llQ
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Revised per Change Request QA-AD-001-04 Change Request approved by SRB 11/21/84 f/-ftf-gg y / 28 8t(
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Revised per Change Request QA-AD-001-05 Change Request approved by SRB 12/16/85 J-M q)f, f(u
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Revised per Change Request QA-AD-001-06 CMJh fu Chance Reouest approved by SRB 6/5/87 6 97 1
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TABLE OF CONTENTS PAGE NO.
FOREWORD...............................
5 1.0 ORGANIZATION 6
2.0 QUALITY ASSURANCE PROGRAM...................
7 2.1 Management.......................
7 2.2 Personnel Qualifications................
8 2.3 Quality Assurance Policies, Goals and Objectives....
8 2.4 Quality Assurance Manual Distribution..........
9.
2.5 CNSI Implementing Procedures..............
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3.0 DESIGN CONTROL 9
4.0 PROCUREMENT DOCUMENT CONTROL 11 i
5.0 INSTRUCTIONS, PROCEDURES AND DRAWINGS.............
12 6.0 DOCUMENT CONTROL 13 6.1 Document Types Controlled 13 6.2 Document Review 13 1
6.3 Document Control.................... 13 l
6.4 Document Change Control (Excluding Drawings)......
14 6.5 Drawing Control 14 6.6 Document Control for vendors..............
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l 6.7 Document Availability 15
- 7. 0 CONTROL OF PURCHASED MATERIAL, EQUIPMENT AND SERVICES.....
15 7.1 Vendor Evaluation 15
- 7. 2 Procurement Requi rements................
16 7.3 Vendor Surveillance 16 7.4 Receiving Inspection..................
17
- 7. 5 Vendor Audit......................
18 8.0 IDENTIFICATION AND CONTROL OF COMPONENTS AND MATERIALS 18 8.1 Components and Material s................
18 8.2 Bulk Raw Material 18 8.3 Identification......................
19 9.0 CONTROL OF SPECIAL PROCESSES 19 9.1 Personnel Certification 19 9.2 Subcontractor Control 19 9.3 Procedures....................... 20 oocmmt QA-AD-001 "F
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10.0 INSPECTION 20 11.0 TEST CONTROL 21 11.1 Test Procedures 21 11.2 Test Records...................... 22 11.3 Test Control for Procured Items 22 11.4 Modifications, Repairs and Replacements......... 22 12.0 CONTROL OF MEASURING AND TEST EQUIPMENT............ 22 12.1 CNSI's Equipment Calibration and Control........ 23 12.2 Measuring and Test Equipment at Subcontractors.....
23 12.3 Inspection Validity 23 13.0 HANDLING, STORAGE AND SHIPPING 23 13.1 Proc a red Items.....................
23 13.2 Transport Casks 24 14.0 INSPECTION, TEST AND OPERATING STATUS............. 24 14.1 Equipment Status....................
24 14.2 Establishment of Examinations and Tests 25 14.3 Hold Points 25 14.4 Check Lists of Examinations, Test and Inspections 25 14.5 Examination of Process Status 25 14.6 Inspection Status 25 14.7 Control of Inspection Stamps..............
25 15.0 NONCONFORMING MATERIALS, PARTS OR COMPONENTS 26 15.1 Internal Nonconformances................
26 15.2 Subcontractor Control 26 15.3 Verification of Rework or Repair Acceptability.....
26 15.4 Nonconformance Disposition............... 26 15.5 Assessment of Nonconformances 27 16.0 CORRECTIVE ACTION.......................
27 17.0 QUALITY ASSURANCE RECORDS...................
28 17.1 Maintenance and Access to Records............ 28 17.2 Contents of Record Files................
28 17.3 Permanent Records 28 17.4 Non-permanent Records 29 17.5 Record Storage Facilities
............... 29 pocuutwr QA-AD-001
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TABLE OF CONTENTS (cont'd) i PAGE NO.
18.0 AUDITS 29 18.1 Audi t Schedul e.....................
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18.2 Audit Personnel 29 18.3 Audit Reports 29 18.4 Audit Follow-Up 30 AP P END I X A - Fi g u re s......................... 31 i
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CNSO 1002/8-78 l
r-3 FOREWORD This program defines and describes the basic policies and procedures used by Chem-Nuclear Systems, Inc. (CNSI) to establish quality assurance requirements for all activities affecting safety related functions of CNSI systems and components, including transport casks.
The activities include designing, purchasing, fabricating, handling, shipping, storing, inspecting, testing, operating and using, maintaining, repairing and modifying. Chem-Nuclear Systems, Inc. top management has approved and fully supports adherence to the policies contained in this program.
It is intended that policies described in this program meet or exceed the appropriate requirements of ASME Boiler and Pressure Vessel Code Section VIII, ANSI N45.2-1977,10CFR50 Appendix B,10CFR71 Subpart H and MIL-Q-9858A.
This program, in full or in part, is subject to review and comment by customer representatives.
Revisions or additions to the program will be made as necessary to conform to the current needs of the company. All revisions will be dated and referenced on the revision page in front of the program.
Copies of the Quality Assurance Program will be issued to the customer and government representatives, as required.
Assigned copies of this program will be serialized and a record maintained showing the transmittal of each revision.
Information copies of the program may be distributed without serialization and they will not be updated with revisions.
This program is reviewed in total by CNSI's management at least once a year to assure conformance to current practices and requirements.
The Quality Assurance (QA) Program for CNSI was established and implemented by the President of CNSI.
The Q.A. Program has the full support of CNSI's management and all CNSI's employees shall adhere to its provisions.
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1.0 ORGANIZATION 1.1 The Quality Assurance organization within Chem-Nuclear Systems, 1
Inc., consists of a Quality Assurance Director with the overall l
responsibility for providing quality assurance of design, fabrication and operation.
He has a stcff of quality assurance personnel reporting to him, who are assigned to the following areas.
l 1.1.1 Vendor inspection 1.1.2 Engineering / Fabrication 1.1.3 Field operations 1.1.4 Barnwell operations 1.2 Personnel assigned to vendor inspection are responsible for l
quality assurance activities to assure CNSI that all vendor and/or subcontractor activities are conducted in accordance with a written program that addresses the applicable criteria of i
CNSI's Quality Assurance Program.
l 1.3 Quality assurance for engineering / fabrication is responsible for verifying that all equipment has been designed, fabricated and tested in accordance with established CNSI procedures and design documents.
1.4 Quality assurance for field operations has the responsibility 4
for audit performance of all CNSI field operations. Audits include verification of field unit operation in accordance with prescribed procedures and instructions.
1.5 Personnel assigned to the Barnwell site are responsible for monitoring all quality-related activities. Special emphasis is placed on assuring that the operation (use) and maintenance of casks licensed per 10CFR71 are conducted in accordance with written procedures. They also have the responsibility for monitoring the rolling stock maintenance and health physics activities performed at Barnwell.
1.6 Quality Assurance personnel shall have the responsibility and authority, specified in written procedures, to perfom the following functions effectively and without hindrance or i
reservation:
- 1. 6.1 Identify quality problems, stop unsatisfactory work, and control further processing, delivery or installation on nonconfoming material; 1.6.2 Recommend and/or approve solutions through proper channels; 1.6.3 Verify implementation of solutions.
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l 1.7 Position descriptions of the Quality Assurance. Director and all l
Quality Assurance personnel shall include prerequisite l
experience and/or required training, which assures that they are i
competent to perfom the assigned duties.
Qualifications for the position of Quality Assurance Director are as follows-1.7.1 A bachelor's degree in a technical field; or equivalent experience; 1.7.2 At least ten years of experience in engineering or manufacturing; 1.7.3 A working knowledge of applicable quality-related codes, standards, and regulatory requirements; 1.7.4 The ability to prescribe, apply and assess compliance
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with the applicable requirements.
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1.8 While other organizations may be delegated the tasks of' establishment and execution of a quality assurance program, it must be recognized that the responsibility for equipment owned and operated by CNSI is retained by CNSI. The Quality Assurance i
Director, upon notification of need for further direction or resolution of Q.A. problems, has the authority to communicate or direct communications with any contractor doing business with CNSI. Ordinarily, such communications will be through the branch of CNSI having responsibility for the function provided by the contractor.
2.0 QUALITY ASSURANCE PROGRAM L
The Quality Assurance Program is comprised of those planned and system-l atic actions necessary to assure adequate confidence that CNSI activi-ties will be conducted in a satisfactory manner and that equipment and t
material will perform satisfactorily in service.
It is the intent of this program to ensure that activities are conducted in a manner that has the degree of reliability on which safety and perfomance of these i
activities were evaluated. The CNSI Quality Assurance Program applies to the design, manufacture and operation of casks, liners, mobile solidification units, demineralization units, decontamination units and the operation of transportation trailers.
2.1 Management The President of CNSI has the responsibility to ensure effective implementation, assess the scope and status, and determine the effectiveness of the Q. A. Program.
Programmatically these functions are accomplished through the use of internal audits, field investigations (audits), customer / user service reports, and internal reporting procedures.
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1 2.2 Personnel Qualifications The QA personnel assigned to perform quality functions are indoc-trinated in accordance with ANSI N45.2.6, NRC Regulatory Guide 1.58, ANSI N45.2.12 and other applicable documents.
Indoctrina-tion and training is established such that:
2.2.1 CNSI personnel responsible for performing quality-related activities are instructed as to the purpose, scope and implementation of quality-related manuals, instructions and procedures; 2.2.2 CNSI personnel performing quality-affecting activities are trained in the principles and techniques of the activity being perfomed; 2.2.3 The scope, objective and the method implementing the indoctrination and training are documented; 2.2.4 Proficiency of persennel perfoming quality-affecting activities shall be monitored and documented on a periodic basis.
2.3 Ouality Assurance Policies, Goals and Objectives 2.3.1 It is the policy of CNSI that all activities which tre governed by the Code of Federal Regulations, licenses, Certificates of Compliance, Letters of Approval, or
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other regulatory requirements, be conducted in accordance with written approved procedures which incorporate the regulatory requirements in a manner which is easily understood by the user / operator.
Quality-related activities shall be performed with specified equipment under suitable environmental conditions and prerequisites shall be satisfied prior to inspection, operation or testing.
Adherence to the procedure requirements is mandatory for all CNSI employees.
Procedures affecting health and safety are required to 'e submitted to the Safety Review Board for approval prior to implementation.
2.3.2 It is the stated goal and objective of the CNSI Quality Assurance Program to provide those mechanisms and environments necessary to achieve a reliable Quality Assurance Program for all activities which affect health and safety or are specified by a regulatory i
requirement.
This goal and objective is achieved through the use of written procedures, management memoranda and management / staff meetings which are designed to evaluate the effectiveness of this program j
as applicable to each CNSI activity.
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7 2.3.3 Differences of opinion between QA personnel and other I
CNSI departments shall be risolved in a meeting of the Safety Review Board.
2.4 Quality Assurance Manual Distribution Measures to control the distribution of the Quality Assurance Manual and revisions thereto are described in Section 6 of this document.
2.5 CNSI Implementing procedures This program incorporates the 18 criteria addressed in 10CFR71, Subpart H and 10CFR50, Appendix B.
Implementation of this pro-gram is accomplished through written approved procedures.
3.0 DESIGN CONTROL 3.1 The Design Control Program at CNSI ensures that design charac-teristics, especially thnse related to safety, are controlled, inspected, and tested; that designs developed by the CNSI Engineering Department meet all applicable regulatory requirements; and that design activities a's carried out in a planned, controlled, and orderly manner.
3.2 A comprehensive system of established procedures and policies is used for developing and implementing design projects, as well as controlling design documents (drawings) and design document di stribution.
3.3 Yarious ine"viouals in the CNSI Engineering Department bear responsibi.ql for the selection and control of design parameters and for the development of design documents.
Their responsibilities are sumarized below:
3.3.1 The Cognizant Engineer is responsible for the initial interpretation of design requirements and for confiming that applicable regulatory requirements are correctly translated into specifications, drawings, procedures, and instructions. Design requirements are also reviewed by Quality Assurance to ens!'r.' that suitable design controls are applied in act." dance with applicable codes, standards and CNSI policies.
3.3.2 The Lead Designer coordinates with the Cognizant i
Engineer and serves as a liaison between drafting,~ the i
Cognizant Engineer, and Quality Assurance. The Lead Designer also supervises drafting and confims that design specifications are properly referenced on drawings and other design documents.
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r-3.2.3 The Draftsman produces accurate and precise drawings that confom to the design specifications and that properly list or reference those specifications.
3.3.4 The Checker reviews the drawings for technical accuracy and checks the design to ensure that the equipment can and will perfom the functions for which it was designed.
3.3.5 CNSI Quality Assurance Department reviews the design to confim that 111 quality assurance requirements have been identified and incorporated in the finished design.
3.3.6 The Project Manager reviews the design and confims that the total design package meets all regulatory requirements and is ready for release and fabrication.
3.4 The Design Control Program provides for design reviews at regular intervals to enstre that design characteristics can be controlled, inspected, r.ni tested, and that inspection and test criteria are identifie(. Formal design reviews may include the Cognizant Engineer, the: Lead Designer, and any other inoividuals or groups involved in the developmant of the design. Design reviews may be called at any time a problem is identified.
Records are kept of these design reviews, and measures are taken to ensure that design errors are corrected and not repeated.
Design controls also extend to other individuals or groups in interfacing design organizations.
3.5 Materials, parts, equipment, and processes are controlled as outlined in Section 7.0 of +.his document. The procurement documents specify all design base requirements including the applicable regulatory requirements, material and component requirements, drawings, specifications, codes and industry standards, test and inspection criteria, and special process instructions. No equipment is released to the requisitioning party until it meets the requirements specified in the purchase order. All materials, parts, and equipment are reviewed for i
suitability prior to selection.
- 3. 6 Drawing changes are accomplished as outlined in Section 6.5 of this document.
Engineering Change Orders (ECO's), Advanced Drawing Change Notices (ADCN's) and/or design documents (drmings) must be approved by the Cognizant Engineer, Quality Ass mance, and the Project Manager before a revised drawing can be released.
Drawing revisions are subject to the same reviews and approvals as the original drawing. CNSI drawing control procedures ensure that obsolete drawing copies are destroyed at the time a revised drawing is released except those necessary for controlled history files.
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4.0 PROCUREMENT DOCUMENT CONTROL l
4.1 The procurement of materials, components, or services affecting assemolies for use at customer sites or other licensed activities is accomplished with a written Purchase Order.
Purchase Order forms are controlled by the Purchasing 1
Department.
Only Purchasing is authorized to release Pun:hase Orders, and is responsible for conforming with established procurement and record keeping procedures. The sequence of events leading to Purchase Order issuance, and the associated record keeping activities comply with CNSI written procedures.
4.2 It is the. CNSI policy that procurement documents, except for administrative supplies, are reviewed by the cognizant department / site manager. Where the department / site manager or his designee detemines that the procurement action is governed by regulatory requirements, the procurement document is submitted to Quality Assurance for review and comment.
4.3 The Quality Assurance reviewer examines the procurement document to assure that complete infomation is provided to identify:
4.3.1 The applicable 10CFR Part 50, Appendix B and 10CFR71, Subpart li requirements which must be addressed; 4.3.2 The design basis technical requirements including the applicable regulatory requirements, material and component identification requirements, drawings, specifications, codes and industrial standards, tests and inspection requirements, and special process i
instructions; 4.3.3 The documentation to be prepared, maintained, and submitted to the purchaser for review and approval; 4.3.4 The records to be retained, controlled, and maintained by the vendor, and those delivered to the purchaser prior to use or installation of the materials or components; 4.3.5 The procuring agency's right of access to vendor's_.
facilities and records for source inspection and audit; 4.3.6 Inspection, witness and hold points as applicable.
4.4 The individual authorized to control and release Purchase Orders prepares the Purchase Order, incorporating all applicable infomation referenced in the preceding paragraph. One copy of all Purchase Orders is maintained in a control-file.
4.5 Procurement documents for spare or replacement parts shall be subject to the same controls that are applied to the original equipment. Changes and revisions to procurement documents are subject to the same review process as original documents.
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4.6 Original and revised procurement documents shall be clearly annotated to indicate the completion of the aforementioned review and approval sequence.
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5.0 INSTRUCTIONS, PROCEDURES AND DRAWINGS 5.1 Activities affecting quality in design, manufacturing, operation, and maintenance are prescribed by documented instructions, procedures or drawings of a type appropriate to the circumstances. They include quantitative and/or qualitative acceptance criteria for determination that the prescribed activities have been satisfactorily perfomed. The activities are accomplished in accordance with the instructions, proce-dures or drawings.
5.2 The purpose of the instructions, procedures and drawings as described herein is to provide and corraunicate standards for the quality determination within the company, to the vendors and co the customers and are directed at maintenance of an overall quality program.
These written instructions are available for review by customer representatives.
5.3 Procedures and instructions are prepared by the cognizant department. All instructions and procedures are maintained current with a documented method of revision.
Instructions, procedures and drawings are readily available t, personnel at locations requiring their use.
5.4 The drawings, instructions and procedures detail, where applicable, any equipment, environmental cinditions and the method to be used to determine the condition of the item under examination.
Prerequisite calibration of all special test equipment is clearly stated in detail. All acceptance criteria are clearly defined.
5.5 Tne CNSI Quality Assurance organization reviews and concurs with inspection plans; test, calibration and special process procedures; drawings, specifications and their changes; and verifies that methods for complying with applicable standards are specified in instructions, procedures and drawings requiring such verification.
5.6 CNSI's Q. A. organization shall review instructions, procedures and drawings to ensure that adequate quantitative and qualitative criteria are present.
1 5.7 CNSI's procedure for document preparation shall be followed in the course of preparation, review, approval and control of instructions and procedures.
Drawings shall be prepared, reviewed, approved and controlled in accordance with written procedures.
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m 6.0 DOCUMENT CONTROL CNSI implementing procedures control drawings, specifications, procedures, instructions and their respective changes.
i 6.1 Document Types Controlled i
Controlled Documents include all documents and their changes affecting the' quality program. These documents include, but are l
not limited to, design drawings and specifications, manufactur-ing, inspection, operating and testing instructions, test proce-dures and design change requests.
The control system provides
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adequate and timely-distribution of all documents to recipients i
listed on a document distribution list and prompt removal of all obsolete documentation.
i 6.2 Document Review l
6.2.1 All design drawings, design procedures and specifica-l tions are issued by the Engineering Department.
They are reviewed and approved by Quality Assurance for i
adequacy and compliance with applicable quality-standards and/or contractual requirements.
The review assures the availability of all infomation required to confom with design requirements.
The review process is the same for document changes.
j 6.2.2 Procedures and instructions are reviewed by CNSI's Quality Assurance.
Procedures which are not~
I safety-related are approved by the cognizant department or site manager. All safety-related procedures are reviewed and approved by CNSI's Safety Review Board.
6.3 Document Control 6.3.1 Execution of an effective document control system requires the following:
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6.3.1.1 Each document shall have an identifying i
number and a complete descriptive title.
- 6. 3.1. 2 Each document shall have means for I
identifying the revision status and the f
effective date of each revision.
6.3.2 The number of copies made and issued of a document is t
controlled by a document distribution list maintained 1
in the document file. The removal of obsolete documents l
and procedures, is accomplished immediately when such -
l material is made obsolete by a new or revised docunent.
Obsolete document copies are destroyed except for a history copy maintained in the document file, t
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6.3.3 Procedures and their changes are distributed on a fomal basis and are of standard format.
In cases of i
emergency, however, approved handwritten temporary procedures or procedures with marked-up changes can be considered satisfactory to reduce the situation from an emergency status.
Temporary Procedures have the same review as permanent procedures except for approval by the Safety Review Board.
They must be made pemanent within 60 days or be cancelled.
6.3.4 Drawings and/or documents sent to a customer ur subcontractor are accompanied by a document transmittal letter showing the drawing and/or document number, revision and date of transmittal. A copy of the transmittal letter is kept on file.
6.3.5 Purchase orders for manufacturing type projects are amended to indicate the effect of engineering changes.
On completed projects as-built drawings and documents are maintained in the project file.
6.4 Document Change Control (Excluding Drawings) 6.4.1 Proposed changes to existing documents shall be recorded on CNSI change request forms. These forms may also be used to submit proposed changes to CNSI customers when their approval is required prior to change incorporation.
6.4.2 All proposed changes are reviewed by Quality Assurance prior to their approval to determine the effect of the change on the quality of the article and the resultant changes in inspection procedures or operations.
Quality Assurance shall approve changes only after receipt of a completed Change Request with authorized approval signatures.
Departments approving the change (s) shall be the same as indicated on the approval page of the document to be changed.
6.4.3 Approved change requests are incorporated in the document.
The changed document is distributed to the individuals indicated in the document distribution log.
6.5 Drawing Control 6.5.1 Drawing changes are made using the Engineering Change Order (ECO) irorm or the Advanced Drawing Change Notice (ADCN) form.
Either form is a one-part reproducible form used to specifically delineate a proposed change.
i The ECO form is also used to submit proposed changes to customers when their approval is required prior to j
change incorporation.
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6.5.2 All proposed changes are reviewed by Engineering and Quality Assurance prior to their approval to detemine i
the effect of the change on the quality of the article and the resultant changes in inspection procedures or operations. Revisions, changes and modifications of 4
2 affected systems are made only after approval of the ECO. Approved changes are maintained in an ECO file by Document Control.
i 6.6 Document Control for Vendors i
6.6.1 Subcontractors and vendors are required to maintain an effective drawing control system when drawings are pro-vided to CNSI as part of the contractual requirements.
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6.6.2 Procurement of articles to CNSI's design requires a document control system that includes assurance of notification changes to the subcontractor or vendor, verification of change incorporation and appropriate. identification of those items on which the change is incorporated.
6.6.3 Procurement of articles of subcontractor's design i
requires a document control system that assures noti-fication of CNSI by the subcontractor of the proposed change, approval of the change by CNSI and appropriate notification of the items on which the change is incor-porated.
6.7 Document Availability
- l Documents shall be available prior to comencement of work at the locations where activities involving them are to be performed.
- 7. 0 CONTROL OF PURCHASED MATERIAL, EQUIPMENT AND SERVICES I
i The procurement control methods CNSI uses establish measures to ensure that procured items and/or services are clearly and adequately speci-fied in procurement documents and are supplied by vendors and subcon-tractors who are capable of producing items and furnishing services which conform to procurement document requirements.
These procurement methods are controlled by procedures anti /or instructions for vendor evaluation, review of procurement requirements and surveillance of ven-dor's facility.
7.1 Vendor Evaluation 7.1.1
- CNSI Engineering, Procurement, and Quality Assurance personne1' participate in evaluation of procurement sources.
Recomendations of procurement sources are based on these evaluations. Results of vendor evalua-tions performed prior to contract award are documented and filed. The evaluations cover review of capabilities and facilities for technical, manufacturing and quality i
perfomance, and include any or all of the following as appropriate:
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l 7.1.1.1 Historical performance data, particularly in product quality and delivery; 7.1.1. 2 Review and comment on vendor's quality l
assurance program; 7.1.1.3 Source audits to verify vendor's implementation of his quality assurance program, as required; 7.1.1. 4 Source qualification programs.
7.1. 2 The evaluation considerations include the elements of l
the Nuclear Regulatory Commission's Quality Assurance Criteria to the extent these criteria are applicable to the equipment being procured. Actions to correct l
deficiencies in the vendor's organization or quality program are resolved with the vendor's management prior to fabrication of ordered items.
7.2 Procurement Requirements Requirements to be met by the vendor are detailed in the pro-curement documents which may include procurement specifications.
Procurement specifications detail the aspects of vendor quality assurance, for example, inspection reports, provisions for in-spection, equipment calibration prior to use, and provisions for inspection after component repair.
The procurement specifica-tion may also require the successful bidder to submit the l
following for CNSI's review:
7.2.1 Special process procedures for performing welding, heat treatment, and nondestructive examination; 7.2.2 Recommended inspection point program; 7.2.3 Appropriate documentation as required by applicable codes, standards and procurement documents; 7.2.4 Notices of nonconformances, their disposition and deviations; 7.2.5 Test procedures in accordance with applicable codes and standards.
7.3 Vendor Surveillance l
7.3.1 CNSI's Quality Assurance is responsible for conducting and documenting vendor surveillance.
Surveillance activities typically include:
7.3.1.1 Witnessing test inspections, nondestructive examinations and various special process operations; DOCUMENT R EV.
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- 7. 3.1. 2 Monitoring heat treatment, welding, cleaning, preserving, and packaging activities;
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7.3.1.3 Verifying vendor confomance with established procedures such as:
- 7. 3.1. 3.1 Use of CNSI accepted drawings and procedures; j
- 7. 3.1. 3. 2 Use of accepted product and process quality planning-7.3.1.3.3 Document change control; j
- 7. 3.1. 3. 4 Material-identification and' traceability control,
- 7. 3.1. 3. 5 Control and calibration of I
measuring equipment; j
7.3.1.3.6 Control of major repair welding.
- 7. 3.1. 4 Reviewing completed product quality documentation and/or checklists prior to l
release of equipment for shipment.
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7.3.2 Documentation of nonconfomances shall be provided by i
vendors as prescribed by this program.
7.3.3 CNSI's quality assurance personnel perform a review to
[
ensure the validity of vendor documentation during in-process fabrication, testing and final inspection stages. The entire documentation package is reviewed prior to shipment of manufactured items. This j
documentation includes material test reports, inspection and test reports, NDE reports and applicable l
code data reports.
'l 7.3.4 The frequency and extent of the surveillance' are l
consistent with the complexity and quantity of the item-(
or service being furnished.
7.4 Receiving Inspection i
Receipt inspections shall be perfomed on purchased items (including spare or replacement parts) to ensure that:;
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7.4.1 Material, components or equipment are properly -
identified and correspond to the receiving documentation, i
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7.4.2 Inspection records or certificates of conformance attesting to the acceptance of material, components and i
equipment are available and are filed in the project
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file prior to use; 7.4.3 Items accepted and released are identified as to their inspection status prior to forwarding them to a controlled storage area or releasing them for installation or further work.
- 7. 5 Vendor Audit Measures for evaluation of vendors are described in the audit section of this document.
8.0 IDENTIFICATION AND CONTROL OF COMPONENTS AND MATERIALS The identification and control as described herein shall apply to com-ponents, production materials, bulk raw materials, parts and assemblies at all stages of fabrication and installation from receipt of compo-nents and material to completion of the system or componer.t.
These requirements shall be imposed on CNSI's subcontractors and vendors.
8.1 Components and Materials 8.1.1 The inspection status of components and materials shall be accomplished by marking, tagging or stamping components or materials at the appropriate stages of fabrication or installation. The inspection status is not changed witnout CNSI QA concurrence.
8.1. 2 Identification of components and materials shall be accomplished with a method that will provide legible l
identification without adverse effect on its life and utili ty.
8.1. 3 Components or materials not suitable for individual marking, shall be individually tagged or sna11 be placed in an identified container.
8.1. 4 The storage area shall contain only components or ma-terials which have been inspected and accepted.
Sur-veillance shall be maintained over the storage areas to j
assure that materials subject to certification control or age limit requirements are properly segregated, dated and controlled. This surveillance shall also include checking for confonmance to proper standards of i
packaging and storage of all components, materials, parts and assemblies.
8.2 Bulk Raw Material 8.2.1 Following the acceptance of bulk raw materials, a tag showing the purchase order, the material identification, DOCUMENT REV.
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3 mill heat number or heat code (if applicable) and the date of receipt shall accompany the material.
8.2.2 If during fabrication all identification has been removed from the part of the material being used, the remnant shall be marked before being returned to stock.
8.2.3 Material marking shall not be affected by contact incident to normal handling, exposure to the elements, shipment or storage. All markings shall offer ready readability and prompt identification of the material.
Physical marking of material shall be accomplished in a i
manner which will not adversely affect the machining, foming or fabrication of the material.
1 l
8.3 Identification Identification requirements shall be detemined during genera-tion of specifications and design drawings.
Identification of materials and parts for safety-related systems or components shall be traceable to the appropriate documentation, such as drawings, specifications, purchase orders, manufacturing and inspection documents, deviation reports and physical and chemi-cal mill test reports.
I 9.0 CONTROL OF SPECIAL PROCESSES l
All special fabrication, installation and inspection processes which r
I have an effect upon the quality of the component, system or fabrication i
operation shall be controlled by process procedures, I
l 9.1 Personnel Certification Personnel responsible for performance, inspection and control of special processes and operations which require special skills and have an effect upon quality shall be certified. Personnel for these processes or operations shall be trained and qualified in accordance with the codes and/or standards applicable to the process. The period of effectivity for all certifications shall l
be specified and each individual shall be re-certified at the l
end of such period as required by applicable standards.
Inspec-tion results and quality audits shall be used as indicators of the need for additional training and re-certification of fabrication, installation'and inspection personnel without regard for established re-certification periods. A record of the names of certified personnel, their skills and certification periods shall be maintained on file for review at the facility i
perfoming special processes.
9.2 Subcontractor Control Special processes perfomed by CNSI's subcontactors and vendors shall be specified in procurement documents and shall be moni-tored by Quality Assurance for confomance to CNSI requirements oocuuswr QA-AD-001 D
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9.3 Procedures Special process procedures shall be reviewed and approved by Quality Assurance to ensure their adequacy.
Process proce-dures shall include the method, qualification requirements, equipment and associated control parameters.
10.0 INSPECTION 10.1 The established inspection program at CNSI verifies the conformance of quality related activities with the applicable requirements. The verification is performed in accordance with written inspection procedures, instructions or drawings.
Personnel performing the inspection are independent from the individuals performing the activity being inspected.
10.2 Equipment modifications, repairs and replacement are inspected in accordance with the original design and inspection requirements unless an approved alternative exists.
Provisions for mandatory inspection hold point identification requiring witnessing by the inspector are incorporated in the appropriate documents, such as procurement specifications, test procedures, Etc.
10.3 The inspection program also provides for identification and documentation of deficiencies discovered during inspection.
10.4 Inspection Procedures 10.4.1 Inspection procedures and instructions are written documents which provide the following information:
10.4.1.1 Identification of characteristics and/or activities to be inspected; 10.4.1.2 Identification of the individual or group responsible for performing the inspection; 10.4.1.3 Acceptance and rejection criteria; 10.4.1.4 A description of the inspection method; 10.4.1.5 Recorded evidence of completing and verifying a manufacturing, inspection, or test operation; 10.4.1.6 Recording inspector or data recorder and the results of the inspection operation.
i 10.4.2 Inspection trocedures and/or instructions are used in conjunction with the applicable specifications or drawings when inspection operations are performed.
Inspection procedures are maintained current by established document control measures.
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10.5 Vendor Inspection CNSI identifies inspection requirements in procurement documents issued to subcontractors and vendors.
The subcontractors and vendors are responsible for inspection of their products, and CNSI Quality Assurance verifies their controls to assure ade-quacy of inspection. Vendor's inspection plans are required to recognize those CNSI notification or hold points specified by procurement documents.
10.6 Indirect Control I
In the event that direct inspection is not possible, indirect control of the inspection process shall be provided by monitor-ing processing methods, equipment and personnel where applicable.
11.0 TEST CONTROL A test control program established at CNSI assures that all required testin; is identified and perfonned in accordance with written test procedures, which incorporate the requirements and acceptance limits specified by the applicable design documents.
11.1 Test Procedures 11.1.1 Test procedures prepared by the responsible CNSI department are reviewed by Quality Assurance in accordance with standards, procedures or instructions that require inclusion of the following quality assurance requirements, as applicable:
11.1.1.1 Requirements and acceptance limits as l
contained in the applicable design documents; 11.1.1.2 Detailed instructions for performing the test; 11.1.1.3 Test prerequisites, including, but not limited to the following:
11.1.1.3.1 Calibrated instrumentation; 11.1.1.3.2 Adequate and appropriate equipment; 11.1.1.3.3 Trained, qualified, and as appropriate, licensed and/or t
certified personnel; l
11.1.1.3.4 Preparation, condition and completeness of the item to be tested; DOCUMENT REV.
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11.1.1.3.5 Suitable and, if required, controlled environmental conditions.
11.1.1.4 Mandatory inspectien hold points for witness by responsible individual; 11.1.1.5 Acceptarse and rejection criteria; 11.1.1.6 Method for documenting or recording test data and results; 11.1.1.7 Designation of the individual (s) or group (s) responsible for evaluating and making' dscisions based on test results.
i 11.1.2 Test procedures shall be subject to document control as outlined in this program.
They thall be maintained current by revisions issued upon changes in specifications, documentation, drawings or contracts.
11.2 Test Records 11.2.1 Records of tests performed shall be prepared, showing the applicable drawing or procedure revision, identification of test performed, date, test data and other essential test information.
11.2.2 The test record shall be signed by the individual performing the test and any test witness, if so requi red. Test records shall be retained.
11.3 Test Control for Procured Items 1
Test control requirements are imposed on vendors by procure-ment documents. They identify the tests to be performed and stipulate that vendors' test procedures be submitted for approval. Tests are conducted by groups within the vendor's organization, and test control systems are monitored during l
Quality Assurance surveillance.
Records of tests are reviewed l
for acceptability during surveillance.
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11.4 Modifications, Repairs and Replacements Modifications, repairs and replacements shall be tested in accordance with the original design and test requirements or acceptable alternatives approved in the same manner as the original.
12.0 CONTROL OF MEASURING AND TEST EQUIPMENT l
Measuring and test equipment with the necessary range and accuracy shall be provided to qualified personnel for the inspection, test and DOCUMENT REV.
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acceptance of material, parts, components and systems.
Equipment accuracy shall be ensured by calibration traceable to national stan-dards or a documented alternate basis for calibration.
l 12.1 CNSI's Equipment Calibration and Control 12.1.1 Inspection and test equipment shall be subjected to maintenance ar.d calibration at periodic intervals by qualified personnel or subcontractors.
Frequency of calibration shall be based on the equipment type, historical experience and operational requirements.
l 12.1.2 Each item of measuring and test equipment shall be l
serialized for record and identification purposes.
A sticker shall be attached to the equipment to indicate date of calibration, due date of next calibration and the stamp or signature of the person conducting the calibration.
A status file shall be maintained for all calibrated equipment.
12.1.3 Measuring and test equipment shall be issued to and l
retained between calibrations by those requiring its use.
Each user has the responsibility to ascertain, prior to use, that the measuring and test equipment calibration date has not expired and that damage or rework has not taken place since the last calibra-tion. Compliance with the above requirements is monitored by Quality Assurance.
12.2 Measuring and Test Equipment at Subcontractors Measuring and test equipment used by subcontractors and vendors engaged in fabricating and furnishing materials, parts and components to CNSI shall be under the surveillance of CNSI's Quality Assurance.
The surveillance shall cover production tooling, jigs, fixtures and other fabrication equipment which controls dimensions, contours, etc., and which is used for acceptance. Surveillance activities include checks to assure that inspection operations are or have been perfomed with appropriate measuring and test equipment.
12.3 Inspection Validity I
Equipment accuracy is nomally checked prior to each use. When measuring and test equipment is found to be out of calibration, measures shall be taken to ensure the validity of previous mea-surements and tests conducted during the period when the equip-ment is likely to have been operating in sucn a condition.
13.0 HANDLING, STORAGE AND SHIPPING 13.1 Procured Items 13.1.1 Measures used to control packaging, shipping, storage DOCUMENT REV.
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and handling of components and material to prevent damage or deterioration shall be documented to reflect contractual or CNSI specified requirements.
Procure-ment documents shall identify the required control measures to vendors.
13.1.2 The vendor must have adequate written work and inspection instructions for storage, preservation and packaging of shipment to protect the products from damage, loss, deterioration or substitution. As required by the equipment specifications and/or l
to approval by CNSI.
procurement documents, these procedures may be subject 13.2 Transport Casks 13.2.1 Transport cask handling and operation shall conform to the written handling and operating procedure for each licensed cask.
13.2.2 Prior to the shipment of a transport cask all conditions of the NRC's Certificate of Compliance (specifications, tests, inspections) shall be satisfied. All required shipping papers shall be prepared and shall accompany the shipment.
13.2.3 Quality Assurance located at Barnwell, S.C., is responsible for inspecting all critical cask handling, I
storage and shipping operations conducted by Barnwell Site Operations.
13.2.4 Established safety restrictions concerning handling, storage and shipping shall be included in the handling and operating procedures for transport casks.
14.0 INSPECTION, TEST AND OPERATING STATUS i
l 14.1 Equipment Status 14.1.1 The inspection, test and operating status of systems and components used for processing or transportation of radioactive material shall be known at all times during manufacturing and operation.
i 14.1.2 Transportation and operating procedures shall include reporting requirements which establish the equipment status at key events (after. unloading, prior to shipment, etc.).
14.1.2 Equipment status will be mainta'ined by operating per-sonnel who are responsible for critical inspection, test and operating activities.
Quality Assurance per-sonnel shall verify equipment status and compliance with i
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procedures.
Bypassing of required tests or other criti-cal operations shall be procedurally controlled under the cognizance of Quality Assurance personnel with the concurrence of the Q.A. Director or his designee.
14.2 Establishment of Examinations and Tests i
14.2.1 In-process and final examinations and tests shall be l
estcblished to ensure confonmance with documented instructions, procedures, drawings, rules and l
regulations.
l 14.3 Hold Points The procurement documents, drawings, quality plans and f
transportation and operating procedures shall establish any required mandatory hold points which shall be reflected in the fabrication or operation schedule.
Hold points shall be l
designated points in the fabrication or. operation schedule j
i beyond which the operations shall not proceed without the concurrence of Quality Assurance because of witnessing, t
examination or testing requirements.
14.4 Check Lists of Examinations, Tests and Inspections-Prepared check lists shall include the document number and revi-sion to which the examination, inspection or test shall be per-l formed. The check list shall have space provided for recording results of examination, test or inspection and for witness sig-natures, initials or stamp and date for activities witnessed.
14.5 Examination of Process Status Measures shall be established to indicate during receiving, fab-rication and equipment operation the status of examinations and tests performed on items, systems and components.
These measures shall provide identifications of those items which conform to i
examination and test requirements and those that do not conform.
14.6 Inspection Status 14.6.1 CNSI inspection stamps or authorized Quality Assurance signature shall be applied to documentation for materials, items, systems and components to indicate the inspection status and to provide traceability to the individual performing the inspection.
I 14.6.2 A tag indicating the inspection status shall normally be applied directly to the item which has been examined.
14.7 Control of Inspection Stamps Inspection stamps shall be serialized for traceability to the individual inspector. Quality Assurance shall control and issue DOCUMENT Rgv SHEET l
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inspection stamps, as required, to authorized personnel.
Stamps removed from service because of loss, employee termination, etc.,
shall be retired for a minimum of three months.
15.0 NONCONFORMING MATERIALS, PARTS OR COMPONENTS Procedures for control of nonconforming materials, parts or components ensure that such materials are adequately identified and segregated from acceptable nterials, if feasible, to preclude their inadvertent use.
15.1 Internal Nonconfomances CNSI materials, parts and components which are detemined to be discrepant shall be identified, reported, and, when feasible, physically separated from acceptable items. The method of identification shall clearly describe the nature of the defect.
Nonconfomance reports shall be forwarded to the designated department (s) for disposition.. A holding area with controlled access shall be provided when necessary for material and/or com-ponent segregation.
Nonconformance reports shall indicate the nature and enent of the discrepancy and the disposition.
Minor discrepancies that can be reworked shall be identified by an Inspection Tag and/or report of rejection until rework has been satisfactorily accomplished.
15.2 Subcontractor Control Subcontractors shall promptly notify CNSI of all deviations from the procurement requirements, such as deviations from the required codes or approved drawings. A nonconformance notice shall be initiated by the subcontractor in accordance with the subcontractor's quality assurance program. After detection of the deviation, further fabrication shall not be performed until the nonconfomance has been resolved. The subcontractor shall supply records of nonconfomance reports disposition " accept as i s" or " repair".
These reports shall be made part of tha inspection records and forwarded with the hardware to CNSI for review and assessment.
15.3 Verification of Rework or Repair Acceptability Acceptability of rework or repair of materials, parts, compo-nents, systems and structures shall be verified by reinspection and/or retesting the item to the original criteria, or by a method which is at least equal to the original inspection and testing method.
Inspection, testing, rework and repair records shall be documented and filed in CNSI quality records files.
15.4 Nonconfomance Disposition The individuals or groups identified on nonconfomance reports shall have the responsibility and authority for disposition of
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nonconfoming items. CNSI QJality Assurance is responsible for reviewing, approving and verifying the disposition of noncon-fomances.
15.5 Assessment of Nonconformances Nonconformance reports shall be analyzed periodically to show quality trends, and the results reported to CNSI management for review and assessment.
16.0 CORRECTIVE ACTION 16.1 Conditions adverse to quality (e.g., nonconfomances, failures, malfunctions, deficiencies, deviations, defective materials, etc.) shall be evaluated to detemine the need for corrective action in accordance with established procedures.
16.2 Corrective action shall be promptly initiated when it is determined that an existing nonconfomity in a material, a i
prccess or a product is due to an assignable cause and is repetitive in nature.
i 16.3 The corrective action shall include:
1(:.3.1 Investigation of discrepancy; 16.3.2 Detemination of cause; 16.3.3 Corrective action to be taken; 16.3.4 Evaluation of corrective action.
l 16.4 The appropriate departments shall be assigned the responsibility for corrective actions.
Corrective action includes, but is not limited to, procurement or manufacturing operations, design, construction and operation. The results of corrective actions shall be documented.
Quality Assurance shall review records.to verify proper implementation of corrective action.
Effectiveness of corrective actions shall be continuously monitored as a function of quality surveillance.
Significant conditions l
adverse to quality, the cause of such conditions, and the l
corrective action taken shall be reported to cognizant levels of CNSI management for review and assessment.
16.5 When corrective action requests affect a CNSI vendor, the vendor shall be required to provide the following infomation:-
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16.5.1 A description of factors contributing to the deficiency; 16.5.2 A description of corrective actions taken to prevent recurrence of the discrepancy in future production.
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17.
QUALITY ASSURANCE RECORDS 17.1 Maintenance and Access to Records The record system maintained by Chem-Nuclear Systems, Inc.
includes the retention of those design, fabrication, inspection and surveillance records essential to demonstrate product quality.
It provides for the identification of materials and their corresponding manufacturing, installation, test and inspection records and certificates. Operating records main-tained will include inspection, test and audit results. All records pertaining to a specific project shall be available for review by the appropriate inspection agencies and/or the customer and/or his representative. All records maintained according to established procedures will be identifiable and retrievable.
17.2 Contents of Record Files 17.2.1 It is the policy of CNSI that adequate records be I
maintained of all component and material inspections l
and tests.
Inspection and test records shall contain i
the following, as applicable:
17.2.1.1 A description of the type of observation; 17.2.1.2 Evidence of completing and verifying a manufacturing, inspection or test operation; 17.2.1.3 The date and results of the inspection or test; 17.2.1.4 Information related to conditions adverse to quality; 17.2.1.5 Inspector or data recorder identification; 17.2.1.6 Evidence as to the acceptability of the results; 17.2.1.7 Identification of the procedure (s) and revision (s) used.
17.2.2 Records shall also be maintained of vendor and subcontractor quality assurance reviews, surveillances and audits, and documents pertaining to CNSI internal quality assurance audits. The files shall also contain procedures and specifications written for a specific project.
17.3 Lifetime Records Lifetime file records shall contain as a minimum: desi pecifications, stress reports or stress calculations, "gn as built" DOCUMENT REV SHEET g
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i and interface control drawings, copies of material test reports, tabulation of materials for "as built" configuration, nondestructive examination reports, including examination results, and disposition reports.
17.4 Non-permanent Records All non-pemanent records required to verify compliance with the applicable codes and the vendor's or subcontractor's Quality Assurance Program shall be maintained until project completion, unless otherwise stipulated.
17.5 Record Storage Facilities Record storage facilities shall be constructed, located'and/or secured to prevent destruction of records by fire, flood, thef t, and deterioration. As an alternative duplicate sets of documen-tation may be maintained in separate locations.
18.0 AUDITS Planned audits shall be perfomed to provide comprehensive, independent verification and evaluation of the CNSI or vendor activity being audited. The audit scope shall encompass evaluation of quality system practices and/or procedures and the effectiveness of their implementa-tion, monitoring of operations and activities, and a review of perti-nent documents and their control and maintenance. Audit checklists shall be prepared prior to conducting an audit.
18.1 Audit Schedule Internal audits shall nomally be conducted once every 12 months.
However, unscheduled audits may be performed more fre-quently in specific areas, if deemed necessary by Quality Assur-ance and/or when the need is indicated by the existence of chronic problems.
Vendor audits shall be conducted at least once every 36 months.
18.2 Audit Personnel Audits shall be performed by CNSI personnel with no direct line responsibility for the function audited. The audit personnel shall have the required level of technical capability to accom-
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plish the audit functions. When required, representatives from various CNSI departments may be called upon for technical advice or assistance.
18.3 Audit Reports 18.3.1 A verbal presentation of the findings, conclusions and recommendations of the audit shall be made to management personnel affected by the audit.
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18.3.2 A written report containing the findings and i
recomendations (if any) presented in the verbal report is prepared and distributed to the responsible divisions and appropriate management.
18.3.3 Audits shall include an assessment as to how well the Quality Assurance Program meets regulatory or other requirements.
18.4 Audit Follow-Up t
18.4.1 The originator of an audit report or a designated alternate is required to follow an open finding urtil action is taken to satisfy the audit item.
Follow-up actions are taken to verify corrective actions are i
implemented and effective.
18.4.2 Responsible management personnel shall evaluate each audit report item and correct deficiencies as promptly as possible after they are revealed.
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Ctt501002/8-78
CHEM-NUCLEAR SYSTEMS, INC.
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PRESIDENT l
CNSI 1
i V.P. &
DIRECTOR CONTROLLER GOVERNMENT. AFFAIRS s
1 s
4 V.P., PROGRAMS V.P. UTILITY
.V.P.,
REGULATORY EXECUTIVE GENERAL MANAGER, j-
& ENVIRONMENTAL SERVICES AFFAIRS
- DIRECTOR, DISPOSAL i
SERVICES
& MARKETING ENGINEERING OPERATIONS t
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9 c:
f QA'-AD-001. Appendix A.
Page 2, Rev. 6-2-88
S 1
I APPENDIX B I
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GESELLSCIIAFT FOR NUKLEAR - SERVICE MBII (GNS)
I QUALITY ASSURANCE PLAN FOR GNSI CASTOR CASKS LICENSED BY TIIE l
UNITED STATES NUCLEAR REGULATORY COMMISSION (QAP) t t
t GNSI QA PLAN - REV. 4 I
h
GNS Gesellschaft fur Nuklear-Service mbH Lange Laube 7 3000 Hannover 1 l
i GNB Gesellschaft fur Nuklear-Behulter mbH ZweigertstraBe 28 - 30 l
l 4300 Essen 1 t
l l
t QUALITY ASSURANCE PLAN FOR GNSI CASTOR CASKS LICENSED BY THE UNITED STATES NUCLEAR REGULATORY COMMISSION l
(QAP) l i
i This copy, with the No.13, QAP, February 1993, Rev. 00 i
has been registered under the name of Doc.No. TQ1/RW/ak-933099 D. Langan, CNSI This copyis subject to revision.
Revision Page Revision Author /
Explanation Section/
Date Status Signature Page l
00 05.02.93 We, First edition 01 l
t 02 i
l 03 r
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i Page 2 QA PLAN - GNSI USNRC LICENSED CASKS i
?
I TABLE OF CONTENTS INTRO DUCTION...............................................
6 STATEMENT OF AUTHORITY AND POLICY 7
SECTION 1.0 OR G ANIZATION....................................
8 1.1 SCOPE...........................................
8
1.2 DESCRIPTION
OF DEPARTMENTS AND FUNCTIONS........... 11 i
SECTION 2.0 QUALITY ASSURANCE PROGRAM....................... 14 2.1 S C OPE..........................................
14 2.2 RESPONSIBILITIES..................................
15 2.3 CONTROL AND DISTRIBUTION OF THE QUALITY ASSURANCE PLAN...........................................
15 2.4 REVISIONS TO THE QUALITY ASSURANCE PLAN............. 15 l
i 2.5 INSTRUCTION, TRAINING, AND QUALIFICATION OF PERSONNEL 16 l
SECTION 3.0 DESIGN CONTROL.................................. 17 3.1 S CO PE..........................................
17 3.2 DEFINITION, INITIATION, AND COORDINATION OF ACTIVITIES...
18 3.3 REVIEW OF PURCHASE ORDER AND DESIGN SPECIFICATION.... 18 3.4 REVIEW OF PURCHASE CHANGE ORDER AND DESIGN SPECIFICATION REVISIONS 18 i
3.5 DEVELOPMENT OF DESIGN DOCUMENTS.................. 18
[
3.6 INDEPENDENT REVIEW (CHECKING) OF DESIGN DOCUMENTS 19 3.7 CUSTOMER APPROVAL OF DESIGN DOCUMENTS............. 19 3.8 REVISIONS TO DESIGN DOCUMENTS...................... 20 3.9 DISTRIBUTION OF DESIGN DOCUMENTS................... 20 i
SECTION 4.0 PROCUREMENT DOCUMENT CONTROL................... 20 t
4.1 S C O PE..........................................
20 l
l 4.2 SELECTION AND QUALIFICATION OF VENDORS AND SUBCONTRACTORS.................................
20 4.3 PURCHASING PROCEDURE............................
21 4.4 CHANGES AND REVISIONS TO PURCHASE DOCUMENTS........ 22 4.5 FOLLOW-UP DELIVERIES.............................
22 1
SECTION 5.0 INSTRUCTIONS, PROCEDURES, AND DRAWINGS............ 22 5.1 S CO PE...........................................
2 2 5.2 D RAWING S.......................................
22 5.3 PROCESS AND TEST PROCEDURES AND INSTRUCTIONS........ 22 5.4 INTERNAL OPERATING PPOCEDURES (IOP)................. 23 l
QA Plan - GNSI USNRC LICENSED CASKS Page 3 i
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I 4
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TABLE OF CONTENTS t
i 5.5 DISTRIBUTION AND CONTROL OF INSTRUCTIONS, PROCEDURES, l
AND DRAWINGS...................................
23 5.6 FABRICATION AND QUALITY CONTROL PLANS.............. 24 SECTION 6.0 DOCUMENT CONTROL...... -........................
24 i
6.1 S C OPE..........................................
2 4 6.2 LIST OF DOCUMENTS
...............................24
[
6.3 STORAGE AND DISTRIBUTION.........................
24 l
6.4 OBSOLETE DOCUMENTS
.............................25 SECTION 7.0_
CONTROL OF PURCIIASED MATERIAL, EQUIPMEN'I', AhD S ERVI CES..............................................
25 i
7.1 S C O PE..........................................
25 l
7.2 RESPONSIBILITIES..................................
25 r
SECTION 8.0 IDENTIFICATION AND CONTROL OF MATERIAL, PARTS, AND COMrONtNTS...................................
26 8.1 S C OPE..........................................
2 6 l
8.2 RESPONSIBILITIES..................................
26 SECTION 9.0 CONTROL OF SPECIAL PROCESSES.....................
26 9.2 PROCEDURES.....................................
26 9.3 PERSONNEL QUALIFICATION..........................
26 9.4 RESPONSIBILITIES..................................
27 SECTION 10.0 INSPECTION......................................
27 10.1 S CO PE..........................................
27 10.2 RESPONSIBILITIES..................................
27 I
10.3
%TI' NESS / HOLD POINT PROGRAM.......................
27 10.4 CONSTRUCTION SURVEILLANCE.......................
28 SECTION 11.0 TEST CONTROL...................
28 11.1 S C OP E..........................................
2 8 11.2 RESPONSIBILITIES..................................
28 11.3 TEST METHODS, PROCEDURES, AND EVALUATIONS 28 SECTION 12.0 CONTROL OF MEASURING AND TEST EQUIPMENT 29 12.1 S COPE..........................................
29 12.2 RESPONSIBILITIES..................................
29 SECTION 13.0 IIANDLING, STORAGE, AND SIIIPPING...................
29 13.1 S CO PE..........................................
2 9 Page 4 QA PLAN - GNSI USNRC LICENSED CASKS
TABLE OF CONTENTS 13.2 PROCEDURES.....................................
30 13.3 RESPONSIBILITIES..................................
30 i
SECTION 14.0 INSPECTION, TEST, AND OPERATING STATUS.............. 30 14.1 S C OPE..........................................
3 0 l
14.2 RESPONSIBILITIES..................................
30 r
SECTION 15.0 CONTROL OF NONCONFORMING ITEMS.................. 30 15.1 S COPE..........................................
30 15.2 RESPONSIBILITIES..................................
31 15.3 INTLRNAL NONCONFORMANCES (GNS).................... 31 l
15.4 GNS VENDOR NONCONFORMANCES.....................
32 SECTION 16.0 CORRECTIVE ACTION..............................
32 i
l 16.1 S COPE..........................................
3 2 l
16.2 PROCEDURE......................................
32 l
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SECTION 17.0 QUALITY ASSURANCE RECORDS.......................
33 17.1 S COPE..........................................
3 3 l
17.2 STORAGE FACILITY.................................
33 17.3 DOCUMENTATION...................................
33 1
SECTION 18.0 AUDITS.....
...................................35 18.1 S COPE..........................................
3 5 18.2 AUDIT PLANNING..................................
35 18.3 AUDIT PROCEDURES................................
36 18.4 AUDIT RESULTS...................................
36 L
18.5 MANAGEMENT REVIEW..............................
37 G LO SS ARY..................................................
3 8 i
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QA Plan - GNSI USNRC LICENSED CASKS Page 5 l
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INTRODUCTION i
The GNS/GNB Quality Assurance System descdbed by this Plan is established to meet the applicable requirements of the following regulations, engineering codes, and standards:
1)
DIN ISO 9001 (EN 29001) Qualittssicherungssysteme.
Modell zur Darlegung der Qualittssicherung in Design /Entwicklung, Produktion, Montage und Kundendienst l
2)
KTA 1401 - General Regoirements for Quality Assurance 3)
American National Standard Institute and American Society of Mechanical Engineers quality assurance program Requirements for Nuclear Power Plants (ANSI /ASME NQA 1 - 1979) 4)
Title 10, Part 50 (10 CFR 50) Appendix B - Quality Assurance Criteria for Nuclear Power Plants and Fuel Processing Plants 5)
Title 10, Part 71 (10 CFR 71) Subpart H - Quality Assurance Requirements for Packaging of Radioactive Material for Transport and Transportation of Radioactive Material under certain Ccnditions l
6)
Title 10, Part 72 (10 CFR 72) Subpart G - Quality Assurance Requirements for an Independent l
Spent Fuel Storage Installation (ISFI) 7)
Title 10, Part 21, (10 CFR 21) Reporting of Defects and Noncompliances l
l Implementation of this Quality Assurance System is accomplished through this Quality Assurance Plan and approved written procedures.
Reproduction of this manual is not authorized without the express written consent of GNS/GNB.
I Page 6 QA PLAN - GNSI USNRC LICENSED CASKS l
l STATEMENT OF AUTIIORITY AND POLICY It is the policy of GNS and GNB to perform all work in strict accordance with contract requirements and guidelines set forth by law. The Quality Assurance Depanment shall assure that the established i
quality assurance system as describd in this plaa is properly implemented and followed for the duration of all GNSI contracts for USNRC Licensed Casks by all permanel of GNS and GNB.
The authority and responsibility for the management of the GNS Quality Assurance (QA) System has been delegated to the Quality Assurance Manager. The Quality Assurance Manager has direct access i
to the higher management and shall have sufficient authority and organizational freedom to assure effective implementation of the quality assurance system requirements. The Quality Assurance Manager j
is also authorized to sign off Cenificates of Conformance and Compliance.
l l
All personnel involved in nuclear safety related construction of CASTOR casks for GNSI must opemte in accordance with this Plan. All personnel performing quality assurance functions shall have sufficient l
authority, access to work areas, and organizational freedom to:
s identify quality problems l
initiate, recommend, or provide solutions to quality problems through designated channels verify implementation of solutions, and assure that funher processing, delivery, installation or use is controlled until proper disposition of a nonconformance, deficiency, or unsatisfactory condition has occurred.
t l
The management shall review and resolve any nonconformance or corrective action as needed that cannot be resolved by the quality assurance personnel.
Any personnel obtaining information which reasonably indicates that a product or activity or basic component supplied by GNS fails to comply with the United States of America (US) Atomic Energy l
Act of 1954, as amended, or any applicable rule, regulation, order or license of the Nuclear Regulatory l
Commission (NRC) relating to substantial safety hazard, or, contains defect which would create a substantial safety hazard as defined by 10 CFR 21 shall immediately notify the management or the l
Quality Assurance Manager of such failure or such defect, for proper evaluation and reporting to the NRC in accordance with 10 CFR Part 21 or to the Customer / Owner in order for them to repon the failure or defect to the NRC.
GNS GESEL -
FF FOR NUKLEAR-SERVICE mbH
\\LW j.
Dr. Klaus Janbe Rudol
'eh Managing Dir or Quality Assurance Manager GNS and GNB GNS and GNB QA Plan - GNSI USNRC LICENSED CASKS Page 7
?
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SECTION 1.0 ORGANIZATION l
1.1 SCOPE i
l 1.1.1 The GNS and GNB Functional Organization Charts are shown in Fig. I and Fig. 2 of this section. Based on the Functional Chart, the organizational structure, levels of authority, and lines of communication for activities affecting quality are clearly established and delineated.
1.1.2 The authority and responsibility is vested with the QA organization to assure that the program is correctly and effectively executed and verified, and to assure a direct access to management at a level where appropriate action can be affected.
1.1.3 All Quality Assurance Department personnel shall have authority and organizational freedom, including sufficient independence from cost and schedule considerations to l
assure that all items are constructed in accordance with specification and contract requirements.
6 l
Page 8 QA PIAN - GNSI USNRC LICENSED CASKS
1 Fig.1 Organization Chart GNS I
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Fig. 2 Organization Chart GNB 1
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l Page 10 QA PLAN - GNSI USNRC LICENSED CASKS I
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1.2 DESCRIPTION
OF DEPARTMENTS AND FUNCTIONS The organization charts of GNS and GNB are given in Fig. I and Fig. 2.
The following description is limited to the main departments involved in the execution of this QAP.
1.2.1 Management GNS-GF, GNB-GF The management bears the overall responsibility for the company and formulates, in this capacity, quality policies. It will implement the quality system and carries out reviews at regular intervals to ensure its continuing suitability and effectiveness.
1.2.2 Quality Management GNS-TQ One particular feature of the quality policy shared by GNS and GNB is the focusing of the quality system of both companies in one department.
The quality management department (GNS-TQ) ensures the introduction and maintaining of the required quality in the planning, production, use, sale, maintenance and disposal of GNS and GNB products.
GNS-TQ deals systematically with two areas of work:
TQ1 - Quality assurance -
compiles, looks after and controls the quality system of GNS and GNB. This includes the compilation, review and looking after of the quality assurance manual and the relevant, alsb applicable, procedures and instructions.
These rule implementation of all quality assurance measures. The performance of audits and evaluation of suppliers, together with the relevant reports, the quality assurance documentation, the control of inspection, measuring and test equipment and the running of a central standards affice are specialized to deal with the requirements of nuclear waste management industry.
TQ2 - Quality control -
carries out, within the framework of clearly defined quality assurance programs, preliminary, production, commissioning and repeat tests as well as administering the test equipment, all in agreement wit the respective persons in charge of assignments and projects.
There are adequate means and well-trained staff to carry out quality assurance and quality control. Another area of quality management is the inspection and continuous follow-up of routines and their results.
The staff of the quality management department are independent of those responsible I
for the carrying out of the work to be inspected.
QA Plan - GNSI USNRC LICENSED CASKS Page 11
In addition, there is an obligation for all managerial staff mentioned in this manual to report immediately to the head of the quality management depanment and to the managing directors in case of fundamental incidents, in order to meet quality requirements.
Fundamentalincidents are, for example, the following:
recognizable deviation concerning adherence to the quality system, refusal of acceptance by customers, authorities or exper complaints from customers, authorities or experts, recognizable quality system deviations by suppliers in carrying out projects.
The quality management department is then set the special task of evaluating inv reports, propose corrective action and supervise their implementation. In serious cases, the quality management department may be obliged to cut short, in agreement with the managing directors, the carrying out of projects or handling of orders.
The managing diretors of GNS and GNB have awarded the head of the quality management department unlimited authority and the responsibility of ensuring and supervising adherence to the quality assurance measm cs. Within this area, he has the authority to issue direcdves.
1.2.3 High-Level Waste (GNS-TB)
The main functions of the department GNS-TB are the handling and the transport u, spent fuel, waste containing high active and other nuclear fuel,' and the disposition of systems. Furthermore TB is responsible for the coordination of activities concerning licensing procedures of GNS and its subsidiary companies.
The department is split in two sections:
GNS-TBH: Project Management and Transports, i
GNS-TBG: Licensing.
1.2.4 Production and Sales (GNB-TP)
Casks for the transport and storage of high-level radioactive waste are bemg manufactured by third parties by order of GNS and GNB. Such orders are managed in the form of projects with extensive specifications:
time schedules and cost plans, 1
compilation of design and fabrication documents, compilation of the technical parameters for the invitation of bids and the placing of orders, l
l Page 12 QA PLAN - GNSI USNRC LICENSED CASKS l
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follow-up of orders (schedules, deviations, corrections),
guarantee of the necessary inspections, tests and approval, production planning and the compilation and inspection of production documents, acquisition of production and installation capacities, control of the production steps and final inspection, production documentation.
The sales section (GNB-TP) analyzes and registers requirements of purchasers and potential purchasers and guarantees the translation into offers meeting quality and requirements standards.
The department adheras strictly to the market conditions and the capacity planning of GNS and GNB in.. rmulating contractual agreements.
The sales department is responsible for the entire management of orders, from acquisition and customer services to the follow-up of orders (schedules, deviations, corrections).
1.2.5 Development (GNB-TA)
The department GNB-TA is responsible for the development and fabrication of transport and stomge casks, handling, transport and storage equipment for fuel assemblies and high-level active
- residues, project definition, the compilation of design parameters and of the concept including licensing documents, a safety analysis report and the license in accordance with Road Traffic Legislation, the performance of burn-up, shielding and criticality calculations, thermal and mechanical calculations, compilation, acquisition and maintenance of program
- software, documentation, casi design and specifications.
1.2.6 Finance and Accounting (GNS-KR, GNB-KR)
The finance and accounting department is, like all the other technical and non-technical departments, subject to the requirements of quality management. The work includes:
invoicing including the business administration of projects and the reports
(
I business planning, the solution of business and tax-related questions, the ensuring of a consistent purchasing routine, the coordination and control of purchasing activities of goods and services for GNS and its subsidiaries.
1.2.7 Personnel and General Services (GNS-KP, GNB-KP)
The scope of responsibility of the personnel department has essentially been designed to meet quality requirements:
personnel planning with permanent analysis of potential and improvement of the staff structure, personnel deployment and service, development of personnel including performance and potential evaluation, junior staff planning, training measures.
4 SECTION 2.0 QUALITY ASSURANCE PROGRAM 2.1 SCOPE 2.1.1 This program is implemented through this plan and approved written procedures, instructions and drawings.
2.1.2 The Quality Assurance Program as described in this Plan is established to:
A.
Include consideration of the technical aspects of the activities affecting quality.
B.
Provide control over activities affecting quality to an extent consistent with their importance.
C.
Provide for the planning and accomplishment of activities affecting quality under suitably controlled conditions. Controlled conditions shall include the use of j
appropriate equipment, suitable environmental conditions for accomplishing the activity, and assurance that the prerequisites for given activity have been established.
D.
Provide for any special controls, processes, test equipment, tools, and skills to attain required quality and for necessary verification of quality such as by inspection or test.
Page 14 QA PLAN - GNSI USNRC LICENSED CASKS
1 E.
Provide indoctrination and training, as necessary, of personnel performing activities affecting quality to assure that suitable proficiency is achieved and maintained.
F.
Assure management personnel implementing the program, or portion thereof, assess regularly the adequacy of the program and assure its effective implementation.
2.2 RESPONSIBILITIES 2.2.1 GNS/GNB performs the functions of contracting with and supplying of materials to subcontractors for which GNS/GNB retains overall responsibility. GNS/GNB accepts overall responsibility for the construction of safety related items and services for which manufacturing and provision is subcontracted to GNS approved vendors.
2.3 CONTROL AND DISTRIBUTION OF THE QUALITY ASSURANCE PLAN 2.3.1 The master copy of this Quality Assurance Plan and all previous revisions shall be maintained and controlled by the Quality Assurance Manager. Issues of controlled copies have assigned control numbers and their issuance is recorded on the distribution list maintained by the Quality Assurance Manager. This list reflects the assignment of the QAP, the date issued, and the date acknowledged. Controlled -QAP shall be distributed only to GNS/GNB personnel, subcontractors, and customer when required. Transmittal letters and written confirmations shall be used for issuance for controlled QAP.
2.3.2 Non-controlled QAPs may be issued by the Quality Assurance Manager and shall be current when assigned, but will not be maintained or audited. A "QAP Distribution List" shall be kept for information purposes on the issuance of non-controlled QAPs.
2.4 REVISIONS TO THE QUALITY
- ASSURANCE PLAN 2.4.1 All QAP revisions shall be reviewed and approved in the same manner as the original issue.
2.4.2 Revisions to the QAP shall be made by section. The Table of Contents shall show the appropriate section revision level and date of revision. All revised sections shall be issued with the revised Table of Contents and cover page indicating Management approval of the Quality Assurance Manager. The QAP revision level shall be that shown on the Table of Contents and cover page.
2.4.3 Approved revisions shall be distributed to controlled QAP holders using the transmittal letter. The letter contains instructions to insert revised sections into the plan and is to be acknowledged. If this acknowledgement has not been received, the QA Plan - GNSI USNRC LICENSED CASKS Page 15
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Quality Assurance Manager shall perform a follow-up and corrective action may result. Records of distribution and acknowledgements shall be maintained by the i
Quality Assurance Manager on the QAP Distribution List.
l 2.5 INSTRUCTION, TRAINING, AND QUALIFICATION OF PERSONNEL 2.5.1 Instruction, training, and qualification of personnel shall be established to assure that suitable proficiency is achieved and maintained. GNS/GNB shall provide instruction, training, and qualification of personnel. All personnel performing activities that l
affect quality or are important to safety shall be properly trained and qualified prior to their performance of such activities.
l 2.5.2 The Quality Assurance Manager shall be responsible for carrying out the objective l
to the extent necessary to assure that all phases of implementation of the QAP are used for continued compliance to contract requirements.
Qualification for the l
position of Quality Assurance Manager shall be as follows:
1 A.
A bachelor's degree in a technical field or equivalent.
B.
At least six years of experience in engineering or manufacturing.
C.
A working knowledge of applicable quality-related codes and regulatory requirements.
D.
The ability to prescribe, apply, and assess compliance wi.th the applicable requirements.
E.
Effective in oral presentation and written communications.
2.5.3 All employees whose duties will affect quality assurance functions within the scope of this QAP shall be indoctrinated to the extent necessary by their respective Manager and/or Supervisor to assure full understanding as to the importance of this program.
2.5.4 Seminars and training courses offered by schools, professional organizations, manufacturers, and other educational institutes, may be utilized to train personnel to assure continued competence in their performance of duties.
2.5.5 Additional instruction and training shall be provided when:
A.
The QAP is extensively revised.
B.
Employees change their area of responsibility.
C.
New employees are hired.
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i 2.5.6 Written records documenting meetings, indoctrination, and training described in this section shall be prepared by the responsible Department and kept by the KP or TQ.
These records shall contain the following information as a minimum.
A.
Date B.
Subject C.
Attendees D.
Instmetor/ Trainer 2.5.7 QA auditing personnel shall be appointed and qualified by the QA Manager on the basis of their education, prior training, and background of work experience. If necessary, additional courses of instruction or training shall be performed to ensure a level of competence to evaluate the object presented for audits.
2.5.8 All personnel performing special processes such as welding, nondestructive examination, heat treating, shall be qualified and trained by GNS, GNB, or their subcontractors in accordance with specified requirements. Training and qualification records shall include test results and shall be kept in the GNS QA file or in the files of subcontractors concemed.
2.5.9 The Quality Assurance Manager shall schedule a meeting at least yearly to review the adequacy of the QAP. The meeting, at which the overall effectiveness of the QAP will be discussed, shall be attended by the Quality Assurance Manager and the Management of TP and TA as a minimum. The discussion and results of the meeting shall be documented.
SECTION 3.0 DESIGN CONTROL 3.1 SCOPE 3.1.1 This section describes methods and procedures to be used to accurately translate requirements of the purchase order and design specification into drawings, design reports, instruction, and procedures to be used for construction; to assure that all required quality standards are included in design documents; translation of requirements to design documents are verified by persons other than those who designed the item; changes to design documents are controlled in exactly the same manner at the original document was prepared.
QA Plan - GNSI USNRC LICENSED CASKS Page 17
3.2 DEFINITION, INITIATION, AND COORDINATION OF ACTIVITIES 3.2.1 Production and sales (GNS-TP) shall define and establish in writing what activities are to be carried out by the several technical areas and what documents are to be prepared. Design (GNB-TA) shall be responsible to see that the persons and offices involved have all the applicable design bases, regulatory requirements, limits, quality standards, and other contract requirements, during the performance of their work.
3.3 REVIEW OF PURCHASE ORDER AND DESIGN SPECIFICATION 3.3.1 The purchase order and design specification shall be reviewed for adequacy with respect to technical, quality, and regulatory requirements.
3.3.2 The Production and Sales (GNS-TP) shall be responsible for having the purchase order and design specification reviewed for technical requirements. The Quality Assurance (TQ) shall be responsible for the review of these documents for quality assurance requirements.
i The review shall be documented on the " Checking of Customer's Order Documents" and returned to GNB-TP.
3.3.3 The Engineering Development and Design (GNB-TA) shall be responsible for the selection of suitable materials, parts, equipment, and processes to be used for nuclear safety related items. (GNB-TA) shall also assure that material, parts, and equipment which are l
standard, commercial (off the shelf). ar which have been previously approved for a different application are reviewed and justified for suitability prior to selection or use.
3.3.4 GNB-TA shall inform the external bodies about conflicts or ambiguities of the Design Specification with respect to the applicable codes and contract found during the review of the specification and contract. documents.
3.4 REVIEW OF PURCHASE CHANGE ORDER AND DESIGN SPECIFICATION REVISIONS 3.4.1 Purchase change orders and revisions to the design specifications shall be reviewed for scope, technical, certification, and Quality Assurance in the same manner as the original issue.
Reviews shall be documented on the " Checking of Customer's Order Documents".
l 3.5 DEVELOPMENT OF DESIGN DOCUMENTS l
L l
3.5.1 All design documents shall be developed in accordance with the requirements defined by the purchase order, design specification, and revisions thereof. Design documents shall include j
required quality standards or reference appropriate quantitative and qualitative acceptance criteria for determining that the items have been satisfactorily accomplished.
l P&ge 18 QA PLAN - GNSI USNRC LICENSED CASKS l
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3.5.2 Design documents shall be developed and approved by GNB-TA as follows:
I A.
Applicable design inputs such as design bases, performance requirements, regulatory requirements, codes, and standards specified shall be identified in the Design Document.
l Appropriate quality standards shall be identified.
l B.
Design documents shall be sufficiently detailed as to purpose, method, assumptions, design input, references, and units such that a person technically qualified in the subject can review and understand the analyses and verify the adequacy of the results.
Calculations shall be identifiable by subject (including part, structure, system, or component to which the calculation applies), originator, reviewer, and date; or by other
~
data such that the calculations are retrievable.
C.
Documentation of design analyses shall include, as applicable, the following:
Definition of the objective of the analyses; Defmition of design inputs and their sources; Results ofliterature searches or other applicable background data; Identification of assumptions and indication of those that must be verified as the design proceeds-I Identification of computer calculations affecting safety or quality of the product, including computer type, code or programming, inputs, outputs, and code or program validation; t
Review and approval.
3.6 INDEPENDENT REVIEW (CHECKING) OF DESIGN DOCUMENTS 3.6.1 An independent review of the design documents shall be performed. The individual or group not responsible for the development of the original design shall be responsible for reviewm' g the documents for conformance with the design Specification, and applicable code. This independent review shall be documented e.g. in the " Document Routing Slip Form" by the reviewer's signeff.
3.7 CUSTOMER APPROVAL OF DESIGN DOCUMENTS 3.7.1 After the development and internal approval of design documents and revisions thereof, GNBTA through GNBTP shall submit the documents to the external bodies for approval, when required by the contract.
i t
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I 3.8 REVISIONS TO DESIGN DOCUMENTS 3.8.1 No design documents shall be revised without prior authorization of GNBTA. This authorization is defined as an approved
- Change Notice".
A'.. approved and completed
" Change Notice" forms shall be kept at the GNBTP of6ce after revision of design documents.
Each revision shall be made readily distinguishable on the documents.
3.8.2 Revisions to design documents shall require the same approval, independent review, and certi6 cation cycle as the original issue.
3.9 DISTRIBUTION OF DESIGN DOCUMENTS 3.9.1 All design documents shall be distributed and controlled in accordance with Section 6.0 DOCUMENT CONTROL.
SECTION 4.0 PROCUREMENT DOCUMENT CONTROL 4.1 SCOPE 4.1.1 This Section describes procurement of items, parts, and services and the manner in which vendors and subcontractors are qualified by GNS. The manner in which purchases are made is described and the responsibilities for each activity delineated.
4.2 SELECTION AND QUALIFICATIO,N OF VENDORS AND SUBCONTRACTORS 4.2.1 Vendors and subcontractors are selected, and if required, qualified by means of an onsite
.;urvey by a qualified quality assurance auditor using a Checklist developed and controlled by TQ for assurance that they have an acceptable quality assurance program or Procedure consistent to the applicable requirements and provisions for maintaining the program (according to the list of sets of regulations in the chapter
- Introduction" of this manual). TQ shall evaluate the acceptability of the vendor or subcontractor from the documented Survey Report and when accepted, place the vendor or subcontractor on the
- List of Approved Manufacturers and Vendors *.
4.2.2 All material, items, and services purchased for Nuclear Safety Related items shall be procured from suppliers listed in
- List of Approved Manufacturers and Vendors".
4.2.3 Vendors or subcontractors of safety related products shall be audited at least once every three (3) years during u e interval in which material or service is being controlled. Special audits may be performed when an area or activity of the vendor or subcontractor is suspected to be deficient or inadequate.
This audit shall be performed in accordance with Section 18.0 AUDITS.
l 4.2.4 The " List of Approved. Manufacturers and Vendors" shall be maintained by TQ and distributed to KR and GNBTP. The List shall be updated and redistributed any time a vendor or subcontractor is added or deleted by TQ.
l Page 20 QA PLAN - GNSI USNRC LICENSED CASKS
4.3 PURCHASING PROCEDURE
)
4.3.1 GNSTP shall be responsible for the preparation of purchase requisition. The purchase requisition shall specify technical and quality requirements and be prepared to include drawings, specification, and instruments that describe the item, parts, or services to be furnished.
4.3.2 The purchase requisition shall state the scope of work to be furnished and shall contain the following information as applicable:
A.
Project name B.
Quantity and description of each item C.
Codes and standards applicable to contract
{
l D.
Material requirements and additional requirements including those not referenced in material specification l
E.
Examination, testing, and inspection requirements i
F.
Submittal record and documentation requirements G.
Necessary design drawings to applicable revisions H.
Requirements for submittal of process procedures I.
Special handling, storage, or shipping requirements J.
Provisions for audit and inspection, right of access by the GNS and its external bodies if requested K.
Submittal of Construction Plan, when required L.
Whether the item is " Nuclear Safety Related" M.
Whether 10 CFR Part 21 applies N.
Requirements for reporting nonconformances with recommended dispositions of l
" repair", *use-as-is", or " scrap" (when materials have been furnished by GNS/GNB).
1 l
4.3.3 Upon completion of a quality related purchase requisition, Quality Assurance (TQ) shall review the requisition. This review shall determine that quality requirements are correctly stated, inspectable and controllable, and that acceptance and rejection criteria are adequate.
Approval shall be documented by sign-off on the purchase requisition prior to issue.
4.3.4 After revie a by (TQ), the Purchasing (KR) shall prepare the purchase order. The purchase order shall contain all information supplied on the (TQ) approved purchase requisition.
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4.3.5 The purchase order shall be reviewed by (GNBTP) and shall be approved by authorized personnel prior to issue by Purchasing (KR).
4.4 CHANGES AND REVISIONS TO PURCHASE DOCUMENTS 4.4.1 Changes and revisions to purchase documents shall be handled in the same manner as the original issue.
l 4.5 FOLLOW-UP DELIVERIES 4.5.1 Inquiries and purchase order for follow-up deliveries according to approved documents may be performed without any new test run by the processing department.
SECTION 5.0 INSTRUCTIONS, PROCEDURES, AND DRAWINGS 5.1 SCOPE 5,1.1
'Ihis section describes the manner in which instructions, procedures, and drawings to be used l
in constmetion are prepared, reviewed, and accepted or approved by GNS/GNB and external l
bodies. Instmetions, procedures, and drawings shall include or reference appropriate quantitative and qualitative acceptance criteria for determining that the prescribed activities have been satisfactorily accomplished.
5.2 DRAWINGS 5.2.1 Drawings are developed and approved in accordance with Section 3.0 DESIGN CONTROL.
5.3 PROCESS AND TEST PROCEDURES AND INSTRUCTIONS 4
5.3.1 GNBTA shall be responsible for the preparation and qualification (if necessary) of all required process and test procedures and instructions.
A.
Where a test program is used to verify the adequacy of a specific design feature in lieu of other verifying of checking processes, it shall include suitable qualification testing of a protype unit under the most adverse conditions.
B.
Design control measures shall be applied to items such as the following: criticality analysis, stress, thermal, and accident analysis; compatibility of materials; accessibility for maintenance and repair; and the delineation of acceptance criteria for inspections and test.
5.3.2 All procedures and instructions after preparation shall be reviewed and approved by GNBTA, GNBTP, and TQ. NDE procedures shall be reviewed and approved by a qualified Level III 1
NDE personnel.
5.3.3 GNS subcontractors may also prepare all necessary procedures and instructions which shall be submitted to GNS for acceptance. NDE procedures shall be approved by a subcontractor Page 22 QA PLAN - GNSI USNRC LICENSED CASKS l
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or GNS qualified level III NDE personnel. The GNBTA, GNBTP, and TQ shall be responsible for the review of subcontractor *s procedures and instructions.
5.3.4 Procedures and instructions approved by GNS shall be submitted to customer through GNBTP, if required by the contract.
5.3.5 Any revision to procedures and instructions shall be reviewed and approved in the same manner as the original issue.
Process procedures and instructions may include:
A.
Welding procedure specifications including procedure qualification records B.
Nondestructive examination procedures (NDE)
C.
Heat treatment procedures D.
Bending and forming procedures E.
Repair procedure F.
All other procedures for special process such as cleaning, sandblasting, painting, packaging, and shipping 5.3.6 Test procedures shall include, as applicable:
l A.
Final inspection (e.g. Pressure Test)
B.
Performance Test C.
Leak Test D.
Instrumentation Test E.
All other test procedures required under the contract t
5.4 INTERNAL OPERATING PROCEDURES (IOP) 5.4.1 Internal Operating Procedures, when required, shall be prepared, checked, approved, and i
issued, provided they do not negate any requirements of this manual.
5.4.2 All internal operating procedures or instructions shall be reviewed by the department issuing the procedure and TQ.
5.5 DISTRIBUTION AND CONTROL OF INSTRUCTIONS, PROCEDURES, AND DRAWINGS 5.5.1 All instructions, procedures, and drawings shall be distributed and controlled in accordance with Section 6.0 DOCUMENT CONTROL.
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5.6 FABRICATION AND QUALITY CONTROL PLANS 5.6.1 GNB-TP or subcontractors shall prepare a fabrication and quality control plan prior to manufacturing of the item. He fabrication and test sequence plan (Fertigungs und PrQffolgeplan, FPP) shall be reviewed by TQ prior to use. TQ shall also assign required witness point and hold point on the plan during the review.
SECTION 6.0 DOCUMENT CONTROL 6.1 SCOPE 6.1.1 nis section describes the issuance, approval, distribution, retention, and maintenance of drawings, reports, procedures, and QA related documents applicable to the construction of safety related items and services. All documents that specify quality requirements or prescribe activities affecting quality shall be controlled to assure that correct documents are being employed.
6.2 LIST OF DOCUMENTS 6.2.1 For each contract, GNB-TP prepares a " List of Documents" which enumerates all technical and quality documents applicable to a contract. The " List of Documents
- shall state the title, identification number, and revision level. He " List of Documents" shall also include distribution status of documents and approval status by customer.
6.2.2 The " List of Documents" shall be prepared after a contract or order is accepted by GNB-TP.
At this time, the order or contract include the customer-supplied documents on which the contract will be based. The customer-supplied documents are specifications, drawings, and other related requirements.
6.2.3 After completion and checking of the documents required for a contract in accordance with Section 3.0 DESIGN GNB-TP will include the " Checking of Customer's Order Documents" into the " List of Documents".
6.2.4 When documents included in the
- List of Documents" are revised, the " List of Documents" shall be revised to reflect the status of documents. The revised " List of Documents" shall indicate the new date of issue and new revision level.
6.2.5 GNB-TP shall distribute the
- List of Documents" and all revisions thereof to GNB-TA and TQ.
6.3 STORAGE AND DISTRIBUTION 6.3.1 GNB-TP shall receive and keep customer-supplied documents and shall distribute copies of the documents to GNB-TA if required, and TQ.
6.3.2 All master copies of documents prepared by GNS and GNB shall be kept by the department which prepares and revises the documents until the completion of the contract. He department which prepares and revises the documents shall assure that appmved changes are Page 24 QA PLAN - GNSI USNRC LICENSED CASKS
i included in documents before implementing the change and that documents are available where work is to be done before the work is initiated. 'Ihe office which prepares and revises the docutaent shall also be responsible for internal distribution of documents. TP shall be responsible for transmittal of GNS/GND documents to customer.
6.3.3 Documents shall be released by GNS to external offices by GNB-TP. The documents shall be properly stamped and transmitted. One of the following stamps shali be used.
A.
For Information Only
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Released for Quotation C.
Released for Construction In cases (b) and (c) authorized GNB-TP personnel sign off the documents in the stamped area.
l 6.3.4 After termination of the contract, all original documents shall be collected and properly stored by GNB-TP. Lifethne records will be sent to GNSI for retention.
6.4 OBSOLETE DOCUMENTS 6.4.1 Obsolete documents distributed to personnel and subcontractors shall be destroyed or marked l
" VOID *.
l SECTION 7.0 CONTROL OF PURCIIASED MATERIAL, EQUIPMENT, AND SERVICES 7.1 SCOPE 7.1.1 Control of purchased material, items, and services to assure conformance with specified requirements shall be accomplished by TQ or by the GNS/GNB subcontractor. GNS selection and qualification of subcontractor shall be in accordance with Subsection 4.2 of this Quality Assurance Manual. GNS/GNB shall review the documentary evidence that material and equipment conform to the procurement requirements. 'Ihe GNS/GNB subcontractor shall implement this control in accordance with his quality assurance program which has been evaluated and accepted by GNS.
7.2 RESPONSIBILITIES 7.2.1 TQ shall verify that control of purchased material, equipment, and services to assure conformance with specified requirements are performed in accordance with subcontractor's quality assurance program.
7.2.2 GNS/GNB may procure materials in accordance with Section 4.0 PROCUREMENT DOCUMENT CONTROL which are shipped direct to the subcontractor's facilities from the material manufacturer or material supplier. GNS/GNB will provide an unpriced copy of the QA Plan - GNSI USNRC LICENSED CASKS Page 25
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1 purchase order and referenced document to the subcontractor for his use in receiving inspection and acceptance of purchased item.
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i SECTION 8.0 IDENTIFICATION AND CONTROL OFMATERIAL, PARTS, AND COMPONENTS 8.1 SCOPE I
8.1.1 Identification and control of material, parts, and components to assure that only correct and
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accepted items are used or installed, shall be accomplished by the GNS/GNB subcontractor.
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"Ihe GNS/GNB subcontractor shall implement the required identification and control in accordance with his quality assurance program which has been accepted by GNS.
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Identification requirements shall be determined during generation of specifications and design drawings. Idendfication of materials and parts for safety-related systems or components shall
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be traceable to the appropriate docunsentation, such as drawings, specifications, purchase l
orders, manufacturing and inspection documents, deviation reports, and certified material test repons.
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8.2 RESPONSIBILITIES i
8.2.1 TQ shall verify that identification and control of material, pans, and components to assure l
that only corrected and accepted items are used or installed, are performed in accordance with the subcontractor's quality assurance program.
SECTION 9.0 CONTROL OF SPECIAL PROCESSES t
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9.1 SCOPE l
9.1.1 Special processes that control quality such as those used in welding and heat treating shall be performed by subcontractor's qualifial personnel, using qualified procedures.
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t 9.1.2 Special processes that verify quality such as those used in non-destructive examination (NDE)
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shall be performed by GNS/GNB or subcontractor's qualified personnel using approved procedures.
9.2 PROCEDURES I
9.2.1 All procedures and instructions used in controlling special processes shall be prepared,
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approved, and controlled in accordance with Section 5.0 INSTRUCTIONS, PROCEDURES, 1
AND DRAWINGS and Section 6.0 DOCUMENT CONTROL.
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l 9.3 PERSONNEL QUALIFICATION 9.3.1 All personnel performing special processes shall be qualified and trained by GNSIGNL or subcontractors in accordance with specified requirements.
Page 26 QA PLAN - GNSI USNRC LICENSED' CASKS l
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A.
NDE personnel shall be qualified in accordance with German Association for Nondestructive Testing (DZGfP or customer accepted equivalent) and/or American Society of Nondestructive Testing (ASNT) recommended practice SNT-TC-1 A.
B.
Welders shall be qualified in accordance with German Welding Code and Standards (DIN), American Society of Mechanical Engineers (ASME) Pressure and Vessels Code Section IX, or American Welding Society (AWS) Welding Code AWS DI.I or customer accepted equivalent.
9.4 RESPONSIBILITIES 9.4.1
'IQ shall verify that control of special processes are performed in accordance with the GNS and subcontractor's quality assurance program and procedures.
SECTION 10.0 INSPECTION I
10.1 SCOPE 10.1.1
' Ibis section describes the method used by GNS to assure and verify compliance by the subcontractor with his quality assurance program, contract specifications, purchase orders, and drawings. Inspection of construction by the GNS/GNB in no way relieves the subcontractor of his responsibilities for compliance with the above documents.
10.1.2 Ifinspection of process material or products is impossible or disadvantageous, indiren costsof by monitoring processing methods, equipment, and personnel shall be provided. Both inspection and process monitoring shall be provided when contro' is madequate without both.
10.2 RESPONSIBILITIES 10.2.1 The TQ shall be responsible for planning and establishing the quality assurance interface with the subcontractor.
10.2.2 The subcontractor through his approved quality assurance program shall be responsible for the execution of all inspections that are required by the contract specifications, purchase orders, and drawings. Inspection methods to be employed and characteristics to be inspected shall be specified. Inspection results shall be documented. Inspection for acceptance shall be performed by qualified persons other than those who performed or directly supervised the work being inspected.
10.2.3 GNS/GNB retains the responsibilityfor the completed item through construction surveillance, l
inspection, and the witness / hold point program described below.
i 10.3 WITNESS / HOLD POINT PROGRAM i
10.3.1 The subcontractor shall be required, by the purchase order, to submi' s fabrication and test sequence plan to GNS/GNB. The TQ shall determine witness / hold points for GNS/GNB.
A copy of the fabrication and test sequence plan shall be kept in the GNB-TP for i
QA Plan - GNSI USNRC LICENSED CASKS i
Page 27 l
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j coordinating purposes. When required, the GNB-TP shall submit the plan to the customer l
for his review and assignment of customer hold / witness points.
10.3.2 The fabrication and quality control plan with GNS assigned hold and/or witness points shall
. be transmitted to the subcontractor for incorporation into his planning. The GNS customer's hold and witness points shall also be incorporated when required.
10.3.3 Hold points designated by the GNS may be waived only by written consent of TQ.
10.4 CONSTRUCTION SURVEILLANCE 10.4.1 The TQ shall be responsible for surveillance of construction to assure compliance with the l
subcontractor's quality assurance program and purchase order requirements. He Quality l
Assurance Manager shall assign qualified personnel to perform the surveillance activity.
l 10.4.2 In-process and final inspection shall be documented by the designated person conducting the inspection by stamping or signing the appropriate space in fabrication and test sequence plan.
SECTION 11.0 TEST CONTROL 11.1 SCOPE 11.1.1 His section describes the test required to verify conformance of an item to specified requirements and to demonstrate that items will perform satisfactorily in service.
11.2 RESPONSIBILITIES i
11.2.1 GNS shall be responsible for specifying the tests required by the Design Specification to be i
performed on items and components.
11.2.2 GNS shall supervise all these tests being performed.
11.2.3 When required by the Contract, the Customer or his representative shall be offered the opportunity to witness all the required tests.
11.3 TEST METHODS, PROCEDURES,'AND EVALUATIONS 11.3.1 All tests such as structural integrity test, leak test, functional test, instrumentation test, etc.,
shall be performed by qualified personnel in accordance with applicable test procedures prepared and approved in a accordance with Section 5.0 INSTRUCTIONS, PROCEDURES, AND DRAWINGS.
Test procedures shall include provisions for assuring that all prerequisites for the given test have been met, that adequate test instrumentation is available and used, and that the test is performed under suitable environmental conditions.
11.3.2 All measuring and test equipment to be used for testing shall be properly maintained and calibrated in accordance with subcontractor's quality assurance program.
Page 2B QA PLAN - GNSI USNRC LICENSED CASKS
c 11.3.3 All testing shall be conducted by the subcontractor and shall be supervised by a representative of GNS designated by TQ. Results of test shall be documented and shall be evaluated by GNS, and when required, by customer for acceptance.
11.3.4 All inspection and test records shall contain the following information as applicable:
A.
A description of the type of observation B.
The data and results of the inspection or test C.
Information related to conditions adverse to quality D.
Inspector or data recorder identification E.
Evidence as to the acceptability of the results SECTION 12.0 CONTROL OF MEASURING AND TEST EQUIPMENT 12.1 SCOPE 12.1.1 Control of measuring and test equipment to maintain accuracy within necessary limits shall be accomplished by GNS/GNB subcontractors. GNS/GNB selection and qualification of subcontractors shall be in accordance with Subsection 4.2 of this QAP. He GNS/GNB subcontractor shall implement his control of measuring and test equipment in accordance with his quality assurance program which has been accepted by GNS.
12.1.2 GNS' own measuring and testing devices are, if not standardized elsewhere, calibrated at least once within a period of two years and checked and documented by *IQ.
12.2 RESPONSIBILITIES 12.2.1 He TQ shall verify that control of measuring and testing equipment is performed in accordance with the subcontractor's quality assurance program.
SECTION 13.0 IIANDLING, STORAGE, AND SIIIPPING 13.1 SCOPE 13.1.1 Control of handling, storage, cleaning, packaging, shipping, and preservation to prevent damage or loss and minimize deterioration of an item shall be accomplished by GNS/GNB or their subcontractors. The subcontractor shall implement his control in accordance with his quality assurance program which has been accepted by GNS. The handling, storage, packaging, shipping, and preservation of an item or equipment by the subcontractor shall be performed in accordance with procedures approved by GNS and when required by contract, approved by the customer.
QA Plan - GNSI USNRC LICENSED CASKS Page 29
i 13.2 PROCEDURES 13.2.1 GNS/GNB or the subcontractor shall be required to reference special handling, storage, cleaning, preservation, or protection procedures, including packaging and packing procedures, on the fabrication and quality control plan.
13.2.2 Handling, storage, cleaning, packaging, shipping, and preservation procedures shall be reviewed and accepted by TQ and customer, when required for compliance with design specification and the purchase order.
13.3 RESPONSIBILITIES 13.3.1 TQ shall verify that the handling, storage, and shipping procedures include, as required: any special environments, examination, test of special handling tools and equipment, marking provisions which are adequate to identify the items shipped, and precautions necessary for their preservation during shipment, and a permanent type of marking or identification when outdoor storage is a possibility.
13.3.3 In the case of GNS' own transport operation, the GNS Transport Department (TBH) is responsible for measures provided for in Sections 13.1,.2, and.3 and is also subject to the QA check.
SECTION 14.0 INSPECTION, TEST, AND OPERATING STATUS 14.1 SCOPE 14.1.1 Inspection, test, and operating status shall be accomplished by GNS/GNB and subcontractors.
GNS selection and qualifitation of subcontractors shall be in accordance with Subsection 4.2 l
of this QAP. The subcontractor shall control his inspection, test, and operating status in j
t accordance with his quality assurance program which has been accepted by GNS.
l 14.2 RESPONSIBILITIES 14.2.1 TQ shall verify that inspection, test, and operating status are controlled and performed in accordance with subcontractor's quality assurance program. The status of inspection and test shall be identified either on the item or in documentation traceable to the item where it is necessary to assure that required inspections and tests are performed and to assure that items which have not passed the required inspections and test are not inadvertently installed, used, or operated. The status shall be maintained through indicators such as tags, markings, shop travelers, stamps, inspection, or other suitable means. The authority for application and removal of tags, markings, labels, and stamps shall be specified.
SECTION IS.O CONTROL OF NONCONFORMING ITEMS 15.1 SCOPE l
15.1.1 This section describes how items that do not conform to specified requirements are controlled i
to prevent inadvertent installation or use.
The control shall include identification, I
Page 30 QA PLAN - GNSI USNRC LICENSED CASKS i
documentation. evalunion, segregation when practichi, disposition of nonconforming items, and notificatiw of organizations affected. Nonconforming items shall be reviewed and axyed, rejected, repaired, or reworked in accordance with documented procedures.
15.2 RESPONSItiii.1 TIES 15.2.1 Any employee of GNS shall be required to repon nonconformances detected during the performance of his duties.
15.2.2 All vendors and subcontractors shall be required to report nonconformances in aceJ.vm with the terms of the purchase order and his quality assurance program.
15.2.3 TQ shall be responsible for the control of all nonconformances and shall report nonconformauces to the ' external bodies, e.g., the customer, as required by the contract through TP.
15.2.4 TQ shall maintain the records of all nonconformances. TQ shall periodically analyze nonconformances to determine quality trends and shall provide the results to the appropriate management.
15.3 INTERNAL NONCONFORMANCES (GNS) 15.3.1 All nonconformances identified by GNS/GNB shall be documented in a repon by the W.
l The report shall include the follow *mg information as a minimum:
A.
Project B.
Manufacturer, GNS/GNB order no.
C.
Item Identification D.
Repon Number E.
Date F.
Description of Nonconformances G.
Disposition (repair, rework, use as is, or scrap)
H.
Cause of Nonconformance I.
Corrective Action to preclude recurrence 15.3.2 The responsible department shall review the reported nonconformance and shall recommend l
a disposition withjustification. He shall then forward the report to TQ. TQ, GhT-TP, and GNB-TA shall review the nonconformance report for approval and authorization of disposition. When.equired by contract, TQ shall submit nonconformance repon to external bodies, e.g., the customer, for approval through GNB-TP prior to authorization of disposition.
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15.4 GNS VENDOR NONCONFORMANCES i
15.4.1 Nonconformances discovered by the vendors shall be dispositioned in accordance with the vendor's quality assurance program and purchase order.
l 15.4.2 When the vendor proposa a disposicion of " repair" or
- rework", he shall submit the i
nonconformance report to GNS TQ for approval through TQ, GNB-TP, and GNB-TA.
l 15.4.3 Upon receipt of vendor's nonconformance repon, TQ shall initiate an internal report and identify the vendor's nonconformance. TQ sha:1 process the report in the manner described in Subsection 15.3. He vendor's nonconformance report can be attached to the GNS/GNB report or used in complete form as a substitute for a GNS/GNB report (e.g., in the case of minor faults).
15.4.4 After approval of disposition by TQ, GNB-TP, and customer, a copy of vendor's and/or l
GNS/GNB report shall be sent to vendor for authorization to proceed or replace the nonconforming item.
SECTION 16.0 CORRECTIVE ACTION 16.1 SCOPE 16.1.1 nis section describes how conditions adverse to quality are identified and corrected as soon as practical.
16.2 PROCEDURE 16.2.1 Corrective action shall be required for all reported nonconformances and audit findings.
16 2.2 TQ shall be responsible to initiate a corrective action request to the appropriate organization.
He TQ corrective action request shall include the fcilowing as applicable:
A.
Person or organization responsible for providing corrective action B.
Violated documents C.
Description of the discrepancy including reference documents as appficable D.
Date when response is required TP shall be responsible to provide the following:
A.
Action to correct the deficient condition l
B.
Action to be taken to prevent recurrence C.
Date when corrective action is completed or will be completed Page 32 QA PLAI; - GNSI USNRC LICENSED CASKS l
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l 16.2.3 The person or organization responsible for nonconformances or audit findings shall determine the cause of the condition adverse to quality and shall take corrective action to preclude recurrence, p
16.2.4 TQ shall review the proposed corrective action and if acceptable shall authorize its implementation by signing the corrective action request.
16.2.5 Follow-up action to verify corrective action implementation by TQ shall be performed by one of two methods:
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The appropriate organization will submit documentary evidence, as required, to verify completion of the indicated corrective action, or The indicated corrective action will be verified by TQ after the schedule implementation date or during the next scheduled audit. This verification shall be documented on the corrective action request.
16.2.6 Corrective action records shall be mamtained and distributed to GNB-TP and other cognizant GNS/GNB departments by the TQ.
SECTION 17.0 QUALITY ASSURANCE RECORDS 17.1 SCOPE l
17.1.1
'Ihis section describes how quality assurance records that furnish documentary evidence of quality are specified, prepared, and maintained as required by the contract. Records shall be legible, identifiable, retrievable, and protected against damage, deterioration, and loss.
17.1.2 Storage of permanent (life-time) records shall be the responsibility of GNS/GNB or GNSI respectively, or external bodies unless special contract arrangements are agreed upon at the time the contract is issued.
t 17.2 STORAGE FACILITY 17.2.1 All records pertaining to quality generated by GNS/GNB shall be properly stored, controlled, and maintained in accordance with the applicable sections of the QAP at GNS/GNB facilities.
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17.2.2 All quality assurance records generated by GNS/GNB subcontractors shall be properly stored, controlled, and maintained in accordance with their quality assurance program accepted by l
GNS at their respective facilities.
l 17.3 DOCUMENTATION 17.3.1 TQ r. hall be responsible for having all quality related documents generated by GNS/GNB and l
submitted by subcontractors reviewed for compliance with the contract requirements.
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17.3.2 Test records shall, as a minimum, identify the inspector or data recorder, the type of observation, the results, the acceptability, and the action taken in connection with any i
deficiencies noted.
17.3.3
'Ihe following documents applicable to Casks fabricated for GNSI shall be submitted to GNSI for retention as Lifetime QA Records:
A.
Records to be provided to the customer and submitted to GNSI for retention upon Cask delivery.
1.
Fabrication and Test Sequence Plans (FPP) 2.
Dimensional Examination (Gauging) Reports 3.
Nondestructive Examination Reports (PT, MT, UT, Visual) 4.
Heat Treatment Records 5.
Material Test Reports and Cenifications Chemical I
Mechanical (Tensile, Elongation, Fracture Toughness, NDTT)
Weld Rod, Wire and Flux Shielding Materials Poison Materials Expendables Contacting Stainless Steel (not applicable if approved cleaning program is implemented) 6.
Test Reports Painting (Film Thickness, Porosity Test)
Leak Test 7.
Pressure Switch Functional Test (Calibration) 8.
Repair Records 9.
Supplier Nonconformance Reports / Internal Deviation Reports 10.
GNS Certificate of Conformance 11.
BAM Certificate of Conformance 12.
Design Verifications (Shielding, Poison) 13.
As-Built Drawings B.
Records a be submitted to GNSI for retention upon Cask delivery:
1.
Audit Records (GNS)
Internal Supplier 2.
Procedures NDE (UT, PT, MT, Visual / Dimensional)
Leak Test Handling, Storage, Packaging and Shipping Cleaning, Surface Preparation and Painting Shielding Design Verification Poison Design Verification Welding and Weld Qualification Repair 3.
Fabrication and Material Specifications Page 34 QA PLAN - GNSI USNRC LICENSED CASKS l
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4.
Parts Lists 5.
Statements of Personnel Qualification Audit Personnel Personr.31 Reviewing / Approving FPP's (does not include BAM/r0v Personnel)
Leak Testing Welding Painting NDE/ Visual 6.
Certificates of Calibration UT Equipment MT Equipment Leak Test Equipment Measuring Equipment Painting (Film Dickness Gauge) 7.
Approved Vendors List 8.
Engineering and Fabrication Drawings 9.
Purchase Orders (Materials)
SECTION 18.0 AUDITS 18.1 SCOPE 18.1.1 This section describes how Quality Assurance Audits are planned, scheduled, and performed to verify compliance with all aspects of GNS/GNB and subcontractor's quality assurance program and to determine their effectiveness.
18.2 AUDIT PLANNING 18.2.1 Audits shall be conducted as planned by TQ. GNS/GNB QAP implementation shall be audited on a yearly basis. Subcontractor's quality assurance program shall be audited at least once within three (3) years during the interval in which material or services are being controlled.
18.2.2 Audits shall be performed in accordance with written procedures or checklist by personnel trained and qualified by TQ and who do not have direct responsibility for performing the activities being audited. Audit personnel shall have sufficient authority and organizational freedom to make the audit process meaningful and effective.
18.2.3 A Lead Auditor shall be appointed when the audit team is composed of two or more auditors.
The lead auditor's responsibilities include orientation of the audit team, coorc'inating the audit process, establishing the pace of the audit, assuring communications within the team and with the organization being audited, participation in the audit performance, and coordinating the preparation and issuance of reports. He audit team members, under the supervision of the lead auditor, shall perform the audit in accordance with Subsection 18.3.3.
QA Plan - GNSI USNRC LICENSED CASKS Page 35
1 18.2.4 Organizations to be audited shall be notified prior to audit. 'Ihe notification shall include information as to the scope and schedule of audits. Special audits may be performed when an area or activity is suspected to be deficient or ineffective.
18.3 AUDIT PROCEDURES 18.3.1 Audit Checklist - Audits shall be conducted using a checklist prepared by the Auditor and approved by the Quality Assurance Manager except tle checklist for TQ which shall be
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reviewed and approved by the management.
i 18.3.2 Entrance Meetinc - A brief meeting prior to audit shall be conducted with the cogmzant l
management ot the organization being audited. The purpose of the meeting is to outline the
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scope of the audit, present the audit plan, introduction of attendees, discuss todit sequence, i
and establish channels of communication as required.
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I 18.3.3 Audit Performance - Objective evidence shall be examined by auditor (s) to verify compliance with the quality assurance program and contract requirements.
Selected elements of the quality assurance program shall be audited to the depth necessary l
to determine whether or not they are being implemented effectively.
l When a nonconformance or program deficiency is found or identified as a result of an audit, further investigation shall be conducted by the audited organization in order to identify the cause and effect of the nonconformance, and to determine the extent of the corrective action required.
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Nonconformanca or program deficiencies shall be acknowledged by a member of the audited organization.
Conditions requiring immediate corrective action shall be reported at once to management of i
the audited organization.
Specific attention shall be given to corrective action on program deficiencies identified during previous audits.
18.3.4 Exit Meetine - At the conclusion of the audit, an exit meeting shall be held with the cognizant management of the audited organization to present and reach agreement on audit j
results.
18.4 AUDIT RESULTS l
18.4.1 The auditor shall prepare an audit report in which the audit results and findings are documented. The report will be submitted to Quality Assurance Manager for evaluation.
18.4.2 Corrective action shall be required for all reponed deficiencies in acco~ lance with Section 16.0 CORRECTIVE ACTION.
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18.4.3 Any nonconformance or corrective action that cannot be concluded by TQ and the organization being audited shall be resolved by the management.
18.4.4 Audit records shall be maintained by the TQ. TQ shall analyze Audit Data and Reports to determine quality trends and the effectiveness of the QAP.
I 18.5 MANAGEMENT REVIEW
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18.5.1 Copies of audit reports shall be distributed to cognizant organization and GNS/GNB management by TQ.
18.5.2 Audit data and reports, including identified trends adverse to quality, shall be reviewed with the management by TQ. This review shall be performed during the annual management review and assessment of the adequacy and effectiveness of the established quality assurance program as described in Section 2.0 QUALITY ASSURANCE PROGRAM.
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l GIDSSARY t
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WITNESS POINT: An operation which is to be witnessed by external bodies or GNS personnel.
Adequate notification shall be provided to the assignor but if he is not present to witness the operation, work shall continue.
I 2.
DISCREPANCY REPORT: A written document used to report and resolve nonconformities or deviations from contract requirements.
3.
ACCEPT: Agree to or concur with. As used herein, acceptance requires signing.
4.
AUDIT: A documented activity performed in accordance with written procedure or checklist to verify, by examination and evaluation of objective evidence, that selected elements of the quality program have been developed, documented, and implemented in accordance with specified requirements. An audit does
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not include surveillance or inspection for the purpose of process control or acceptance of material or items.
f 5.
AS-BUILT-DRAWING: Drawings reflecting as-constructed condition and has been reconciled with the design report.
6.
DESIGN REPORT: Design document which includes, if appropriate, stress r.nalysis or calculations or both to show that allowable limits are not exceeded for the loading specified in the Design Specification.
Drawings used for design and construction must be identified in the desia report.
7.
DESIGN DOCUMENTS: These documents include design specifications, design calculations, design drawings, and design reports.
8.
SCRAP: Nonconforming items which are unfit to be used as is, repaired, reworked, or returned to
[
vendor shall be identified as scrap and segregated from conforming material.
9.
VERIFICATION: An act of confirming, substantiating, or assuring that an activity er condition has been satisfactorily performed or created in compliance with specified requirements. As used herein, i
verification required signing or sing-off.
10.
EXTERNAL BODIES: Customers, authorities, experts, inspectors.
11.
APPROVAL: Official permission. As used herein, approval requires signing.
i 12.
GNS: Gesellschaft fQr Nuklear-Service e_b!!, West Germany GNB: Gesellschaft fiir Nuklear-Beh!ilter mbH, West Germany 13.
USE-AS-IS: A disposition to accept a deviation from the original requirement without repair.
14.
CORRECTIVE ACTION: Action undertaken to identify the cause of a deficiency, discrepancy, or l
nonconformity, to correct a condition adverse to quality and prevent recurrence.
l 15.
VENDOR: A material manufacturer, material supplier, supplier of services, or subcontractor.
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c>
16.
NONCONFORMITY: A deficiency in characteristic, documentation, or procedures which renders the quality of an item or activity unacceptable or indeterminate.
17.
REWORK: An activity undertaken with a previously used process or technique on the item to attempt to restore that item to the original condition and design requirement.
18.
ITEM: Any product material and safety related structures, systems, and components for technical installations.
19.
QUALITY ASSURANCE (QA): All those planned and systematic actions necessary to provide adequate confidence that all items designed and constructed are in accordance with the Detign Specification and contract reqairements. Quali y assurance includes quality control.
t 20.
QUALITY CONTROL (QC): The examination of the physical characteristics of a material or item to establish conformance to the acceptance standards associated with those examination.
21.
REPAIR: An activity to attempt to restore a nonconforming item or material to an acceptance condition although it does not meet the original requirements.
22.
REV: Revision 23.
REVIEW: Examine in detail. Reviewing of documents shall always require sig ling or stamping and dating by the authorized reviewer, either on the document (s) or on records traceable to the document (s).
When review is performed it is for acceptance or approval.
24.
SURVEY: A documented evaluation of an organization's ability to perform activities as verified by a determination of the adequacy of the organization's quality program and by a review of the implementation of that program at the location of the work.
25.
SUBCONTRACTOR An organization which designs, purchases material, fabricates, assembles, installs, and tests GNS/GNB designed items in accordance with the design documents and purchase order.
26.
SIGNING AND SIGN-OFF: When used herein, means signing, initialing, or stamping and always with the date.
27.
DISPOSITION: An action taken to resolve a nonconformance.
28.
PROCEDURE: A step-by-step instruction for carrying out processes, inspection, control, examination, and test.
29.
DRAWINGS: Design drawings used for fabrication of an iam. Design drawings are documents prepared by GNS/GNB, or others, in accordance with the Design Specification which depict the dimensional and material requirements of the item.
30.
HOLD POINT: Hold points at which witnessing is required by GNS/GNB and/or customer shall be indicated in the fabrication and test sequence plan. Work shall not proceed beyond mandatory witness / hold points without the consent of GNS/GNB and customer as appropriate.
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.o 31.
CERTIFICATE OF CALIBRATION: Written statement attesting to the calibration of equipment based on review of supporting documentation.
32.
STATEMENT OF PERSONNEL QUALIFICATION: Written statement attesting to the qualification of personnel based on review of supporting documentation.
9 I
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