ML20198M431
| ML20198M431 | |
| Person / Time | |
|---|---|
| Site: | 07100967 |
| Issue date: | 07/10/2020 |
| From: | Schatz U, Schroder J Gesellschaft fur Nuklear-Service mbH |
| To: | Document Control Desk, Office of Nuclear Material Safety and Safeguards |
| References | |
| T1213-CO-00002 GNS-QAPD-001, Rev 0 | |
| Download: ML20198M431 (36) | |
Text
GNS Gesellschafl fOr Nuklear-Service mbH
- Postfach 10 12 53
- 45012 Essen Document Control Desk Director, Division of Spent Fuel Management Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 Our reference:
T1213-CO-00002 Contact person:
Dominik Bussmann Phone:
+49 (0)201/ 109-1891 Fax:
+49 (0)201/ 109-1186 Email:
dominik.bussmann@gns.de Date:
10.07.2020 Request for NRC docket number and application for NRC approval of GNS's Quality Assurance Program
Dear Division of Spent Fuel Management:
Gesellschaft fOr Nuklear-Service mbH (GNS) applies for NRC approval of its Quality Assurance Program based on the enclosed Quality Assurance Program Description GNS-QAPD-001 Rev. 0 "Quality Assurance Program Description (QAPD)"
As GNS applies for the QAP approval in advance of the application for package approval acc. to 1 O CFR71 of the CASTOR geo69 cask design, GNS requests for a separate NRC docket number for this QAP application.
GNS's Quality Assurance Program is based on ASME NQA-1 Edition 2008 Add. 2009a and Edition 2015, and fully satisfies the quality assurance requirements of 10 CFR Part 71, Subpart H and 10 CFR Part 72, Subpart G.
Please don't hesitate to contact us if there are any questions or if additional information is required.
Sincerely, GNS Gesellschaft fOr Nuklear-Service mbH etJ Schroder, Managing Director (CTO)
E ure GNS-QAPD-001 Rev. 0 GNS Gesellschaft fur Nuklear-Service mbH Frohnhauser Strar!e 67 45127 Essen Telefon +49 201109-0 T elefax +49 201 109-1100 www.gns.de HRB Essen 11213 Commerzbank AG, Essen ISAN DE17 3604 0039 0124 3237 00, SIC COSADEFF Sayerische Landesbank OOsseldorf IBAN DE56 7005 0000 0004 3662 43, SIC BYLADEMM USt-ldNr. DE 171892160, Steuer-Nr. 111/571411234 Vorsitzender des Aufsichtsrates: Or. Guido Knott u.~
Ulrike Schatz, Quality Director
{J oD'-f rvf'.1SS20 GescMflsfOhrer:
Dr. Hannes Wimmer (Vorsltzender)
Georg Buth Dr.-!ng. Jens Schn:ldar
µ05 5
Quality Assurance Program Description (QAPD)
Headquarters:
GNS Gesellschaft fifr Nuklear~Service mbH (GNS),
Frohnhauser Strasse 67 45127 Essen, Germany 1 Shop:
Shop Millheim, Kranbahnallee 3 I
45473 Millheim an der Ruhr, Germany Document No.:
Revision:
Date of issue:
Responsible for Document:
Prepared by:
Quality System Manager Reviewed by:
Quality Director Approved by:
Managing Director GNS"7QAPD-001 0
Essen, 09.07.2020 Managing Director of GNS Name Date S. Wellnitz 09.07.2020 U. Schatz I
-09.07.2020 Dr. J. Schroder 10.07.2020 NS
Revision Date Author comment regarding changes; statement of page, if applicable 0
09.07.2020 S. Wellnitz First issue GNS-QAPD-001 Rev. 0 Page 2 of 35
s Table of Content Statement of Authority...................................................................................................... 4 0
1 2
3 4
5 6
7 8
9 10 11 12 13 14 15 16 17 18 19 Introduction.................. :.......................................................................... 5 Organization.................,.......................................................................... 6 Quality Assurance Program.................................................................... 9 Design Control............. '......................................................................... 11 Procurement Document: Control........................................................... *14 Instructions, Procedure$, and Drawings............................................... 15 Document Control........ *........................................................................ 16 Control of Purchased lt~ms and Services............................................. 17 Identification and Contrql of Items........................................................ 20 Control of Special Processes............................................................... 21 lnspection..................... 7....................................................................... 22 Test Control.................. :....................................................................... 24 Control of Measuring and Test Equipment........................................... 25 Handling, Storage, and Shipping.......................................................... 26 Inspection, Test, and Operation status................................................. 27 Control of Nonconforming Items........................................................... 28 Corrective Action........... *....................................................................... 29 Quality Assurance Records.................................................................. 30 Audits.................................................................................................... 32 Appendix.......................,....................................................................... 34 GNS-QAPD-001 Rev. 0 Page 3 of35
Statement of Authority I
The GNS Quality Assurance Program (QA~) described in this "Quality Assurance Program Descrip-tion" (QAPD) is applicable to packaging, equipment and service for processing, transportation, and storage of spent nuclear fuels and radioactive waste provided by GNS. This QAP meets the require-ments of ASME NQA-1 Edition 2008 Add. 2p09a and Edition 2015.
The Managing Board is responsible to establish overall expectations for the direction, development, the effective implementation, and support of the OAP. The Managing Board has assigned one Man-aging Director (MD) represented by the Chief Technical Officer (CTO).
i The assigned MD has delegated the responsibility for the establishment, training, administration, and enforcement of this QAP to the Quality Director (QD). The Quality Management Department acts as a staff position reporting to the MD and is :independent of all other organizations within GNS. The Quality Management Department assumes !ine responsibility for assuring compliance with this state-ment of authority.
The MD charges all personnel involved iri activities affecting quality with the responsibility of upholding I
and abiding by the Quality Assurance requirements in the OAP. The members of the Quality Man-1 agement Department are authorized sufficient freedom to identify quality problems; initiate, recom-1 mend or provide solutions; verify implementation of solutions; and control further processing of ser-vice(s) or delivery of a nonconforming item,ldeficiency or unsatisfactory condition until proper dispo-sition has been completed. They are indepe:ndent from production costs and schedules.*
I i
While it is the responsibility of everyone at '.GNS to assure that quality and reliability objectives are achieved, the overall responsibility for the ~evelopment, maintenance and assurance of the imple-mentation of the QAP has been assigned toi the QD, who reports directly to the MD of GNS.
I I
I All personnel assigned to operations subjeci to the requirements of this program shall be required to familiarize themselves with the policies and bbjectives set forth in this program. They shall be respon-sible for executing those policies, explicitly qr implied, pertinent to their assignments.
I Dr. Jens Schroder Managing Director I
GNS-QAPD-001 Rev. 0 Page 4 of 35
GNS 0
Introduction I
The company GNS Gesellschaft fur Nuklear-Services mbH (GNS) supplies packaging, equipment and services for processing, transportation, and storage of spent nuclear fuels and rad_ioactive waste.
This Quality Assurance Program Description (QAPD) addresses specifically the activities at its head-quarters in Essen and the fabrication at its Shop M0lheim and the GNS subsidiaries.
For more than 40 years, GNS with around 450 employees has been providing reliable and efficient solutions for nuclear waste management during operation and decommissioning of nuclear power plants and nuclear facilities. The GNS group is a specialist in the disposal of high-level radioactive waste and spent fuel elements from nuclear reactors as well as in the safe processing, packaging and storage of low-and intermediate-level radioactive waste and residual materials resulting from the I
operation of nuclear power plants. In addition, GNS offers comprehensive solutions for all phases of decommissioning and dismantling, from the creation of fuel-free conditions to the dismantling and packaging of large components such as the :reactor pressure vessels and their internals.
In Germany, as a subsidiary of the four major energy suppliers, GNS is entrusted with the complete disposal of residual materials and waste from the German nuclear power plants up to their delivery to the interim storage facilities of the Federal Government. Beyond this responsible task, GNS also suc-1 cessfully offers its products and services fo~ the disposal of nuclear power plants on an international scale.
For the transport and interim storage of fuel elements, GNS already developed a then novel type of container, the CASTOR, four decades agoi Today, the CASTOR family with its different, continuously developed series_ is an internationally re-nowned trademark and synonym.for nuclear safety, reliability and innovation.
GNS-QAPD-001 Rev. 0 Page 5 of 35
1-Organization 1.1 General This chapter defines and describes the GNS operational organization and assigns authority and gen-eral responsibility for the establishment and implementation of the Quality Assurance Program (OAP).
Representative Organization Charts are presented in the Appendix. The GNS Functional Organiza-tion Chart shows the levels of authority and distribution of responsibilities under the Managing Board.
The Quality Management Organization Chart shows the basic distribution of responsibilities under the Quality Director. Finally, a Generic Project Organization Chart is provided to show that, for any specific project undertaken by GNS, independence is maintained by the Quality Management function.
I The main positions that have QA responsibilities and authority are described below. Detailed func-tional descriptions are contained in the QAM 11.
1.2 Quality Assurance Responsibilities and Authorities GNS is managed by a Managing Board, which is responsible for establishing overall expectations for the direction, development, implementation, and support of the OAP. The Managing Board has assigned one Managing Director to enforce the OAP with his signature for approval on the cover sheets of the QAPD and QAM 11. The Manaiging Director has delegated the responsibility for the establishment, training, administration, and enforcement of the GNS OAP to the Quality Director.
The Quality Director, reporting directly to the Managing Director, is responsible for the establish-ment, preparation, indoctrination, maintenance, and implementation of the OAP. The Quality Direc-tor reviews the status, adequacy, and implementation of the OAP at least annually and reports this status to the Managing Director. The Quality Director is independent from the pressure of cost and scheduling considerations insofar as the QAP is concerned. He may delegate any of the functions assigned to him to another individual who is part of the Quality Management Departmen1!:, but he shall retain the responsibility for accomplishment of the function.
The Quality Management Department, which assumes line responsibility for assuring compliance with GNS' OAP, is independent of all other organizations within GNS. Hence, it is independent from the pressure of cost and scheduling considerations insofar as OAP matters are concerned.
The Quality System Manager is responsible for System related topics of the OAP. The Quality As-surance Manager is responsible for the assurance related topics of this OAP.
GNS-QAPD-001 Rev. O Page 6 of 35
s 1.3 Quality Assurance Responsibilities for Specific Projects l
Quality Assurance at GNS is an interdisciplinary function that involves all organizations. Furthermore, Quality Assurance_ encompasses many fundtions and activities within these organizations, including all executives and employees whose activities affect quality.
i Functional Divisions have been establishe'd in accordance with the distribution of tasks. Divisional I
Directors are responsible for their assigned domain, reporting directly to the Managing Board. The implementation of Quality Assurance throughout the various divisions for the design, procurement, I
fabrication, operation, and services at GNS must, therefore, be considered the direct responsibility of I
the organization performing the work and cannot be considered the sole domain of any single Quality Assurance group.
When a specific project is undertaken, a Project Organization is formed for that project, taking per-1 sonnel and disciplines from the functional organization. Per the QAM II, the quality requirements for the project are identified in the Quality Project Manual which is developed specifically for that project.
For projects affecting more than one functional division, a Project Director is assigned. In these cases, the Project Director has the overall responsibility for the quality aspects of his project and I
shall maintain in close liaison to the Quality'.IDirector on all matters that affect quality.
1.4 Delegation of work Individuals who are assigned specific respqnsibilities within the QAP may delegate performance of the activity to others reporting to them proyided they are qualified, certified, and/or authorized as applicable. The delegation of responsibility must be properly documented, and the responsipility shall remain with the assigned individual.
1.5 Authority to Stop Work Quality Management, Assurance, Inspection and Examination personnel have the authority and the responsibility to stop work in progress which is not being done in accordance with approved proce-dures or where safety or SSC integrity mayJbe jeopardized. This extends to off-site work performed by suppliers furnishing safety-related materials and services to GNS.
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- l.
I 1.6 Quality Assurance Organizational Independence I
I Persons or organizations charged with the development, enforcement, or measurement of the ade-GNS-QAPD-001 Rev. 0 Page 7 of 35
s quacy and effectiveness of the QAP have the authority and organizational freedom necessary to ef-fectively discharge those responsibilities. 81.Jch persons or organizations shall be independent of di-rect pressures of cost, schedule, or production. Their authority and organizational freedom shall be sufficient to:
- identify quality problems,
- initiate, recommend, or provide soltitions,
- verify implementation of solutions, and
- withhold and segregate nonconforming material or other action, including stopping work, to maintain program integrity.
Furthermore, they shall have direct access to responsible management at a level where appropriate action can be mandated.
Persons performing quality assurance functions such as checking, verifying or reviewing the work of others have authority and organizational freedom to a degree sufficient to properly discharge their I
assigned quality assurance responsibilities.,Such persons or organizations charged with verifying the conformance to established requirements shall not be directly responsible for performing the work.
However, when authority or organizational freedom are restricted for any person performing quality assurance functions, an established line of communication to responsible management must exist sufficient to prevent suppression of those qyality assurance functions and/or to resolve any disputes.
1.7 Interface Control Where more than one organization is involv~d in the execution of activities, the responsibilities, inter-faces, and authority of each organization sh~II be clearly defined and documented in the Quality Pro-ject Manual (QPM), which is described in Section 2.1. Further, external interfaces between organiza-tions, and changes there-to, shall be defined and documented within the QPM.
GNS-QAPD-001 Rev. 0 Page 8 of 35
s 2
Quality Assurance Program 2.1 General GNS's Quality Assurance Program is basec;l on ASME NQA-1 Edition 2008 Add. 2009a and Edition 2015, and fully satisfies the quality assuraMce requirements of 10 CFR Part 71, Subpart H and 10 CFR Part 72, Subpart G. The Quality Assurance Program consists of, but is not limited to, the following elements:
- Quality Assurance Program Description (QAPD)
- Quality Assurance Manual (QAM 11)
- Quality Assurance Procedures (referenced in the QAM II)
- Quality Project Manuals (QPM), which are developed for each specific project Items or services that are designed, manufactured, or procured under the QAP are classified using the "Graded approach to classify items and services" according to procedures identified in the QAM
- 11.
The QAP includes monitoring activities like internal and external audits and surveys against ac-ceptance criteria specified in the QAM II, Quality Assurance Procedures, and QPM, to ensure that the activities affecting the quality of produced Items and supplied services are performed satisfactorily.
The QAP provides for indoctrination, training, and qualification/certification of personnel as necessary to perform and manage activities affecting the quality of an Item or service.
As mentioned above, quality requirements for a specific project are identified in the Quality Project Manual (QPM) which is developed for that project. The QPM does not establish new quality require-ments. Rather, it provides a roadmap to show how the quality requirements in the QAP will be imple-mented in that particular project.
2.2 Indoctrination and Tr~ining of' Personnel involved in activities affecting Quality I
Personnel involved in performing or managing activities affecting quality of items and services and/or the construction of packaging and equipment for processing, transportation and storage of spent nu-clear fuels and radioactive are identified an9 given indoctrination and training, in accordance with the QAM II. Likewise, training records are maintained in accordance with the QAM II.
2.3 Training, Qualification and Certification of Inspection and Test Personnel I
The Quality Assurance Manager is responsible for performing documenting the indoctrination and GNS-QAPD-001 Rev. 0 Page 9 of 35
NS training of GNS's Inspection and Test Personnel. Inspection and Test Personnel shall be re-certified at periodic intervals not to exceed 3 years.,f\\ny person who has not performed Inspection or Testing activities in his qualified area for a period of 1 year shall be reevaluated by a re-determination of his required capability. The qualification of personnel shall be certified in writing in accordance with the QAM II.
2.4 Training and Qualification of Nondestructive Examination Personnel GNS's NOE personnel performing NOE activities on Items are trained, qualified and certified in ac-1 cordance with QAM II, which describes the requirements for education, training, examination and certification. Qualification is based on SNT-TC-1A.
2.5 Training and Qualification of Audit Personnel Audit Personnel are formally qualified and certified in accordance with the QAM II. The Quality Di-rector is responsible for the training, qualifibation, and certification of audit personnel. Per the QAM I
II, a list of qualified and certified audit personnel shall be maintained by the Quality System Manager.
2.6 Management Review The Quality Director shall evaluate the adequacy and effectiveness of the QAP at least annually prior to the end of the year, and document this evaluation in a report to the Managing Director for review and assessment. The Managing Director shall document this review including his overall I
expectations for the effective implementation of the QAP for the next evaluation period by signature and date on the annual Management Review Report. The Managing Director shall also recommend additional corrective actions if required.
GNS-QAPD-001 Rev. 0 Page 10of 35
3 Design Control 3.1 General Design activities to be defined, controlled, and verified cover both (1) packaging for the transport and storage of spent nuclear fuel and radioactive waste, and (2) equipment for nuclear application. The I
respective design activities are prescribed in procedures that are referenced in the QAM 11. All design activities are under the responsibility of the Design Manager or Engineering Manager, respectively.
This chapter addresses the overall require~ents applicable to both kinds of design activities, which include the following:
- Design Input,
- Design Process,
- Design Analysis,
- Design Verification,
- Change Control,
- Interface Control,
- Software Design Control, and
- Documentation and Records.
The qualifications of the specialists on the design team are described in the QAM II.
3.2 Design Input The design input shall comprise all relevant :technical requirements and boundary conditions, includ-ing all pertinent design parameters, such as shielding, criticality, thermal and hydraulic. The design input will also identify requirements for mai~tenance and repair, inspection, cleaning, handling, and storage.
Design input shall consider all affected parties and relevant interfaces, such as customers, regula-tions, environment, and regulatory authoriti~s, and shall be documented as specified in the QAM II.
After satisfactory coordination, review and approval of all design inputs from the various sources, a i
design specification shall be prepared as the central internal document for subsequent design activi-ties.
GNS-QAPD-001 Rev. 0 Page 11 of 35
3.3 Design Process The design methods, as well as applicable materials, parts, computer codes, equipment and pro-cesses that are essential to the functions of :the components and systems being designed are speci-fied in the QAM II. Further, applicaQle documents to be generated during the design process, including the following, are specified in the QAM II:
- Technical reports
- Parts lists
- Drawings
- Material and test specifications
- Fabrication specification 3.4 Design Analyses The design analyses shall be coordinated, ircluding engagement of the preparation of the respective documentation in a planned and controlled manner according to the QAM 11.
3.5 Design Verification The QAM II includes provisions for determining the preferred design verification method. Design ver-ification shall be completed before release of the final design for licensing or serial manufacturing.
The adequacy of the design shall be verified by personnel who were not involved in the design activ-ities.
3.6 Change Control Design changes, whether during the design phase or after final design, are prescribed and controlled in accordance with the QAM II. This includes field changes, temporary or permanent modifications.
Key provisions of design change control are:
- Changes shall be reviewed and approved by the same specialists or organizations that re-viewed and approved the original documents, I
- Correct "as-built" drawings and documentation will be maintained, and
- Any changes in the design that CC>Uld impact the Certificate of Compliance for a packaging will be approved by the NRC prior to implementation.
GNS-QAPD-001 Rev. 0 Page 12 of 35
NS
- 3. 7 Interface Control Design team members are selected on a project-related basis according to procedures referenced in the QAM II. The Project Manager is responsible for overall project coordination. Internal and external design interfaces are established and maintained according to the QAM II.
I 3.8 Software design control The design activities do not include the design of computer software for nuclear facility applications.
The requirements for the application of computer programs used for the design analyses, including code verification and validation, and the management of electronic records, are prescribed in QAM II.
3.9 Documentation and Records In addition to the design output documents prescribed in the QAM 11, design documentation shall also comprise less formal documented design input. Such design input may be gained, for example, ac-cording to the list of technical requirements and boundary conditions, records or memos from kick-off or other steering meetings. Further documentation or records may comprise design specification, rel-evant conceptual documents, drafts, or reco~d/memo of conceptual or design reviews.
Prescriptions regarding the management of design documents beyond the preparation process are addressed in Chapters 5 and 6 of this QAPD.
GNS-QAPD-001 Rev. 0 Page 13 of 35
NS 4
Procurement Document Control 4.1 General This chapter describes in general how material, items, and services, such as calculation, destructive-or non-destructive testing, and calibration, shall be purchased and controlled. The procurement in-cludes requisition, quotation, and order processes.
The QAM II specifies who shall be responsible for maintaining the above mentioned procurement processes. Adequate quality is assured by implementing applicable design basics and other require-ments according to the QAM II. Suppliers identified shall be controlled as described in chapter 7 of this QAPD.
4.2 Content of the Procurement Documents Procurement documents issued at all tiers of procurement include provisions for the following:
- Scope of Work,
- Technical Requirements,
- Quality Assurance Program Requirements,
- Right of Access,
- Documentation Requirements,
- Nonconformances, and
- Spare and Replacement Parts.
4.3 Procurement Document Review Procurement documents issued at all tiers shall be reviewed as specified in the QAM II.
4.4 Document Changes Procurement document changes affecting the technical or quality assurance program requirements shall be subject to the same degree of control as utilized in the preparation of the original documents.
The originator is responsible for the follow-up.
GNS-QAPD-001 Rev. 0 Page 14 of 35
@GNS 5
Instructions, Procedures, and Drawings 5.1 General All activities affecting the quality of services provided, or items and systems constructed and delivered to-or by GNS, are performed in accordanc~ with approved documented instructions, procedures, or drawings. Each is prepared to the level of detail needed according to the safety significance of the item, complexity of the task or activity, work environment. and worker proficiency. Documents either include or reference quantitative and qualitative acceptance criteria to assure that the prescribed ac-tivities have been satisfactorily accomplished.
5.2 Processing Approval of these documents, and revisions thereto, is performed by the appropriate levels of man-agement. The process for the preparation, review and approval of these documents is described in the Document Control Matrix in the QAM 11. 'Issuing of said documents, as well as the utilization of the Document Control Matrix, is described in the QAM II. Approved procedures pertaining the QAM II are listed and maintained by the Quality System Manager.
Issuing procedures/specifications for Special Processes is described in chapter 9 of this QAPD.
5.3 Changes Changes to instructions, procedures, and drawings shall be handled, reviewed, and approved as the original documents.
GNS-QAPD-001 Rev. 0 Page 15 of 35
s 6
Document Control 6.1 General This chapter describes how documents specifying quality requirements or prescribing activities affect-ing quality are prepared, revised, reviewed,, approved, and distributed by qualified and authorized personnel, who are listed in the Document Control Matrix, contained in the QAM II. All controlled documents can be identified throughout GNS and GNS subsidiaries as outlined in the QAM II.
6.2 Controlled documents and their distribution Controlled.documents and revisions theret~ are identified by a unique identification prescribed in the QAM II. GNS and its subsidiaries use differ~nt methods to manage the flow of documents prescribing quality requirements or activities affecting quality. However, all authorized personnel at GNS and its subsidiaries have access to the GNS document system. The system only provides access to the current versions of said documents.
Further, the List of Applicable Documents,: prescribed in the QAM II, ensures that only the current valid documents are being employed by GNS and subsidiaries. The Document Control Manager prepares and maintains the List of Applicable Documents. All documents prescribing quality require-ments or activities affecting quality shall be identified with title, document no. and revision. Quality personnel and project/team personnel identified in the Quality Project Manual shall automatically be informed in case of issuance and/or revision.
Documents that are printed out shall be considered as uncontrolled. Controlled documents shall be handled in regard to a revision service. However, controlled documents that are distributed externally with the flag "For information only" are regarded as uncontrolled and will not be handled in regard to a revision service.
6.3 Document changes Changes to controlled documents may be initiated by the Project Manager or Quality Director, who may delegate to the authorized personnel the requested change to be implemented in the controlled document. Changes to controlled documents are marked as prescribed in the QAM II.
Revisions shall be handled as described above with respect to distribution of the original controlled documents.
GNS-QAPD-001 Rev. O Page 16 of 35
NS 7
Control of Purchased Items and Services 7.1 General This chapter describes how purchased items and services are controlled and the requirements for selection of suppliers and control of supplier';s nonconformances. Items or services that are designed, manufactured, or procured under the QAM :11 are classified using the "Graded approach to classify items and services," as described in the QAM II.
7.2 Supplier Evaluation and Selec.tion Suppliers are selected from the Approved S,uppliers List (ASL) based on an evaluation of their capa-bility to provide items or services that conform to procurement document requirements. If there are no suppliers on the ASL able to provide the item or service, a new supplier will be qualified and added.
The supplier qualification process consists of several steps. Suppliers are evaluated based on the following:
- History of providing identical or similar material or items or services, including commercial grade items or services,
- Current quality records supported by information that can be evaluated,
- Quality System/Assurance Manual; procedures, process-sheets, and all necessary support-ing documents, and
- Ability to meet Part 71 and Part 72requirements.
Suppliers that satisfy the qualification process are added to the ASL. The Approved Suppliers List shall be verified by the Quality Director. It shall be reviewed and revised as necessary in case of changes to a supplier's information.
7.3 Bid evaluation Bid evaluation includes determination of the supplier's capability to conform to the technical and qual-ity assurance requirements.
7.4 Control of Supplier generated Documents The documents prepared or provided by th'3 supplier shall be submitted to GNS, controlled, and dis.:.
tributed per the QAM II. A supplier's gener~ted documents would include:
- Certified Material Test Reports, GNS-QAPD-001 Rev. 0 Page 17 of 35
NS
- Certificate of Compliance,
- Certificate of Conformance,
- Calibration Records,
- Fabrication/Casting plans, and/or
- Drawings.
7.5 Acceptance of Items or Services The method of acceptance for items and services received shall be specified by GNS. The QAM II contains provisions for determining the extent to which supplier surveillance will be performed during fabrication, assembly, modification, repair, a~d shipment, to ensure conformance with purchase order requirements. A source surveillance shall be planned and performed in accordance with the QAM II.
The Receiving Inspection process is determ.ined and described in the QAM II.
7.6 Control of Suppliers Nonconformances Nonconformances may be identified by GNS or the supplier.
Per the QAM 11, rionconformances. identified by the supplier must always be handled by the supplier's Quality Management System. The supplier shall notify GNS about any Nonconformance occurring during the construction of an item or providing of a service. The supplier's notification shall be in writing and shall include the following:
- description of the nonconformnce;with respect to the requirements of the Purchase Order and related documents, and
- the supplier's recommendation for disposition of the Nonconformance (e.g. use-as-is, repair, or scrap, including a technical justification).
The nonconforming items or service will not be released or allowed to continue until GNS has evalu-ated the supplier's report, including recommendations, and made a determination. The supplier shall follow up on the approved disposition according to his Quality Management System and shall prepare quality documents/records describing the implementation of the disposition.
7.7 Commercial Grade Items and Services When Commercial grade items and servic~s need to be procured, the control of such purchased items and services shall performed as describe~ in the QAM II.
GNS-QAPD-001 Rev. 0 Page 18 of 35
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s 7.8 Counterfeit, Fraudulent, and Suspect Items (CFSI)
Per the QAM II, inspection activities shall be performed in accordance with procurement documents and process control documents. If these activities disclose counterfeit and/or fraudulent items, or items which are suspect, they shall be considered as nonconforming until conformance to specified requirements can be established.
7.9 Records As stated above, documents that are prepared or provided by the supplier shall be submitted to GNS and controlled and distributed per the QAM IL GNS-QAPD-001 Rev. 0 Page 19of 35
8 Identification and Control of Items 8.1 General Items shall be identified and controlled for traceability during manufacturing to ensure that only correct and accepted items are used or installed.
8.2 Identification methods The QAM II contains provisions describing the method of marking, the content of markings, and other marking specifics for items to be received during fabrication and assembly, and if applicable, installa-tion and use. Specific controls shall be used to document their identification.
8.2.1 Limited Life Items Items with limited shelf life requirements are specified by the supplier of the Item. These requirements shall be transferred into GNS internal instructions. Operating life requirements of items shall be es-tablished by GNS.
8.2.2 Maintaining identification of ~tored items In case GNS or GNS subsidiaries procure more items than requested in the customer's purchase order as spare parts, the QAM II details t~e requirements for maintaining the identification of these items.
GNS-QAPD-001 Rev. 0 Page 20 of 35
9 Control of Special Processes 9.1 General All special processes that control or verify quality are performed by qualified personnel using qualified procedures in accordance with specified requirements.
9.2 Process Control As specified in the QAM II, special processes shall be controlled by written instructions, which includes procedures, drawings, checklists, or other appropriate means. These instructions shall contain or ref-erence qualification requirements, in accordance with applicable codes and standards, for personnel and equipment, as well as conditions necessary for accomplishment of the process. The instructions shall also include acceptance criteria.
9.3 Records Records shall be appropriately maintained for the qualified personnel, processes, and equipment of each special process.
GNS-QAPD-001 Rev. 0 Page 21 of 35
@G S 10 Inspection 10.1 General The QAM II specifies how inspection activities (i.e., pre-process, in-process, final, and receipt) are planned, executed, and documented to vedfy conformance of items with specified requirements and acceptance criteria. The inspection requirements and acceptance criteria shall be contained in the applicable design documents or other pertinent technical documents.
Inspections shall be performed by qualified individuals who were not involved in the performing or I
direct supervision of the work to be inspect,ed.
10.2 Hold Points Hold points shall be identified and handled in accordance with the QAM II. For Hold Points, work shall only proceed after the authorized individual has completed an inspection and signed and dated where required. In no case shall work progress beyond a Hold Point until approved in writing by the author-ized inspector.
10.3 Inspection Planning The responsible design function shall specify the characteristics of the inspection, including the I
method of inspection and the applicable acceptance criteria as specified in the codes or standards, procurement documentation, design documents, or other pertinent technical documents.
Sampling that is applied during inspectior;i processes shall be based on standard statistical methods with engineering approval.
10.4 In-Process Inspection Inspections of items under construction ~r otherwise in process are defined by the QAM II. If direct inspection of processed items is not performed, indirect control shall be maintained by monitoring processing methods, equipment, and personnel.
Surveillance at suppliers shall be performed in accordance with the QAM 11.
i 10.5 Final Inspection The QAM II contains provisions for the; Final Inspection of assembled Items. This inspection shall ensure that all nonconformances identified in earlier inspections are resolved, that full traceability of GNS-QAPD-001 Rev. 0 Page 22 of 35
s the item is possible, that the marking is correct, and that all examinations and tests are completed satisfactorily.
10.6 Receiving Inspection Receiving inspections are to be performed in accordance with provisions in the QAM II, to ensure that the item received at GNS meet all requirements. Included in the receiving inspection are actions to be taken in case of nonconformances.
10.7 Inspection during operations Once accepted and placed in operation, periodic inspections (e.g. in-service inspections) or surveil-lances of structures, systems, or components are determined and specified in accordance with the QAM II.
10.8 Inspection Records Per the QAM II, Inspection Records shall as a minimum, identify the following:
- Items inspected,
- date of Inspection,
- Inspector,
- type of observation,
- results of acceptability,
- reference to information on actio~ taken in connection with Nonconformances, and
- document no. and revision used in performance of the activity.
All Inspection documentation shall be properly maintained.
GNS-QAPD-001 Rev. 0 Page23 of 35
11 Test Control 11.1 General This chapter describes the requirements for tests required to collect data such as for siting or design input, to verify conformance of an item to specified requirements, or to demonstrate satisfactory per-formance for service. Tests shall be planned and executed on a project-specific basis. Characteristics to be tested and test methods to be employed shall be specified as per the QAM II. Test results shall be documented and evaluated against the test requirements and acceptance criteria.
11.2 Test Requirements Test requirements and acceptance criteria are specified by the responsible design function based on applicable design documents and other pertinent technical documents. Required tests shall be con-trolled under appropriate environmental conditions using the tools and equipment necessary to con-duct the test in a manner to fulfill test requirements and acceptance criteria within a test program/spec-ification. The tests performed shall obtain the necessary data with sufficient accuracy for evaluation and acceptance.
Tests are surveilled by qualified and certified Inspection and test personnel and witnessed by person-nel not having performed the activity themselves.
11.3 Test Procedures For each test a program/specification shall be prepared and approved by competent personnel in accordance with the QAM 11. A test program/specification shall include or reference such things as test objectives, required records, prerequisites, acceptance criteria, and monitoring requirements.
11.4 Test Results Test results shall be documented and evaluated to ensure that test requirements have been satisfied.
They shall be properly maintained as QA records, per the QAM II.
11.5 Test Records Test records shall include such information as items tested, evaluating personnel, type of observation, results and acceptability, and action taken in connection with any deviations noted.
GNS-QAPD-001 Rev. 0 Page 24 of 35
G S 12 Control of Measuring and Tes1 Equipment 12.1 General This chapter describes how measuring and test equipment (MTE) used in verification of code and specification requirements are calibrated and controlled. Personal measuring and test equipment is not permitted.
12.2 Selection To verify Code and specification requirements MTE shall be selected based on the type, range, ac-curacy, and tolerance specified in design documents as per the QAM II. The MTE must be listed in the "List of Measuring and Test Equipment," which ensures that measurement and testing is per-formed with adequate accuracy.
12.3 Calibration and Control Calibration of MTE shall be traceable to national standards or international standards known to be equivalent to national standards. If there are no national standard identifiable, the manufacturer's recommendations shall be used and listed in the "List of Measuring and Test Equipment!'.
Calibration may be subcontracted to approved suppliers on the Approved Suppliers List. In case MTE needs to be purchased, GNS shall provide necessary specifications.
12.3.1 Nonconformances in MTE i
When MTE is lost, damaged, found to be. out of calibration, or without a calibration sticker, the non-conformance will be documented. In the case where the equipment is damaged, out of calibration, or without a proper sticker, it shall be remo~ed from service immediately. All Items measured or tested with the discrepant device since its last acceptable calibration shall be evaluated. These Items shall be listed as nonconformances and will be. handled accordingly.
12.4 Records i
. The QAM II describes the process for reviewing the results of subcontracted calibration for ac-1 ceptance. The acceptance of the calibration is certified by GNS. Calibration records shall be identified, traceable, and maintained as QA records.
GNS-QAPD-001 Rev. 0 Page 25 of 35
NS 13 Handling, Storage, and Shipping 13.1 General Handling, cleaning, storage, packaging, shipping, and preservation of Items shall be performed in accordance with the QAM II.
13.2 Special requirements Special equipment (such as containers, shock absorbers, and accelerometers) and special protective environments (such as inert gas atmosphere, specific moisture content levels, and temperature lev-els} shall be specified, and their existence :verified by design documents or project-specific require-ments.
13.3 Procedures, Tools, Equipmer:,t, Operators and Marking or Labeling The QAM II contains directions for ensuring that no damages or mix-ups occur during handling or storage and transport of materials or Items; inside GNS.
Handling methods and tools are to be carefully selected to avoid damage during handling.
Finished Items may only be transferred to storage when they have been verified free of any damage, and have been marked according to the requirements as indicated.
Special handling tools and equipment, su~h as cranes, shall be specified in instructions per the QAM 11, and used and controlled as necessary to ensure safe and adequate handling. They shall be in-spected and tested in accordance with th~ work safety requirements at annual intervals and properly documented. All operators shall be experienced and trained in the use of the equipment.
GNS-QAPD-001 Rev. 0 Page 26 of 35
NS 14 Inspection, Test, and Operation status 14.1 General The QAM II contains guidance for properly identifying the status of inspections, tests, and operating conditions of Items. The identification is performed by the individual responsible for the specified ex-amination. Status indicators are controlled in accordance with. the QAM 11, to ensure that all organiza-tions responsible for ensuring quality are aware of the current status.
GNS-QAPD-001 Rev. 0 Page 27 of 35
GNS 15 Control of Nonconforming Items 15.1 General This chapter describes how nonconforming Items are controlled. A Nonconformance is defined as not conforming to specified requirements. Nonconformances shall be handled in accordance with the QAM II. This pertains also to nonconformances that fall under 10CFR21.
15.2 Identification Nonconforming Items, material, and services shall be clearly identified. Nonconforming measurement and test equipment (MTE) is discussed in chapter 12.
15.3 Segregation A nonconforming Item shall be segregated either by physically moving it to a segregated area (Quar-antine Area) if possible, or by clearly identifying it as a nonconforming item. Processes stopped for a nonconformance shall be communicated to the involved personnel.
15.4 Disposition Nonconforming Items shall be evaluated, and recommended dispositions shall be proposed by au-thorized personnel for further processing, delivery, installation, or use. These authorized personnel shall be qualified in the area they are evaluating and have an adequate understanding of the require-ments. Items that are reworked and/or repaired shall be reexamined in accordance with applicable procedures and with the original acceptance criteria to be determined per the QAM II.
GNS-QAPD-001 Rev. 0 Page 28 of 35
s 16 Corrective Action 16.1 General This chapter describes the controls for the corrective action system which is defined as those measures taken to rectify conditions adverse to quality and to preclude recurrence of Nonconform-ances. This corrective action system is also extended to the Suppliers.
16.2 Documentation Per the QAM 11, anyone at GNS who suspects significant conditions adverse to quality shall inform the Quality System Manager promptly. The Quality System Manager is responsible for verifying con-ditions adverse to quality and documenting these conditions. Further, he shall initiate a Corrective Action Report whenever a Nonconformance Report is issued that indicate$ a significant condition adverse to quality. Significant conditions adverse to quality require a determination of the cause and corrective action to preclude recurrence.
Nonconformances and Corrective actions based on Audits are documented by the Lead Auditor on an audit nonconformance report according to the QAM 11.
16.1 Follow up Follow up of Corrective Actions at GNS (except for Audits) is performed by the Quality System Man-ager and all others identified in the Corrective Action Report.
16.2 Evaluation for Management Review Per the QAM 11, the Quality System Manager shall review the Nonconformance Reports and Correc-tive Action Reports, internal and external audit reports, customer audits and other areas for evaluation at least annually to determine if there are any conditions or trends adverse to quality. This review shall be documented in the Management Review Report. A summary of Corrective Actions shall be sub-mitted to the Managing Director at least once per year for his review.
GNS-QAPD-001 Rev. 0 Page 29 of 35
NS 17 Quality Assurance Records 17.1 General This chapter describes how Quality Assurance records for Items and Services, complying with the requirements of the NQA-1, are generated, identified, controlled, and filed. Both electronic and hard-copies are retained. The QAM II contains additional provisions.
17.2 Generation of Records Generation of records is described in the QAM II. The records to be generated are specified and identified. Depending on the type of records produced, they are classified as either lifetime records or nonpermanent records.
All records shall be legible, accurate and completed as appropriate to the work accomplished.
Records (lifetime records and nonpermanent records) generated and identified by a unique ID-No.
shall provide information to permit traceability to the Items or activities to which they apply.
17.3 Authentication of records Documents in either electronic or hard copy form shall be considered valid records only if either stamped, initialed, or signed and dated by authorized personnel. Records which are completed and completely signed may only be corrected by the individual department responsible for preparation, review, approval, and acceptance.
17.4 Classification Records are classified as lifetime or nonpermanent in accordance with the QAM II. This classification also takes into account the requirements of the NQA-1 req. 17 and Owner/Customer requirements.
17.5 Receipt, storage, retention, and maintenance of records Per the QAM II, each organization is responsible for organizing and implementing receipt controls for temporary and permanent storage. Records received from suppliers shall be reviewed for complete-ness, correctness, and legibility. All records shall be maintained for their retention periods according to the QAM II.
In case customer, jurisdictional, or regulatory requirements define a different record retention period than described within the QAM II, such deviated retention periods shall be described in the Quality GNS-QAPD-001 Rev. 0 Page 30 of 35
s Project Manual. In no case will a document's retention time be shorter than specified in the QAM II.
17.6 Maintenance of records Records are maintained and protected from degradation, damage, or loss.
Filed records can be retrieved from storage or GNS databases by qualified personnel in a controlled manner.
Each individual having original records is responsible for its protection against damage or lost from the time of receipt until the transfer to storage.
GNS-QAPD-001 Rev. O Page 31 of 35
GNS 18 Audits 18.1 Scope This chapter describes how internal and external audits are planned, scheduled, prepared, performed, documented, and followed up in accordance with the QAM II, to comply with the requirements of the NQA-1.
18.2 Scheduling Internal Audits are scheduled in a manner to provide coverage and coordination with ongoing QA program activities by using the "Audit Schedule" found in the QAM II. Each ongoing activity shall be audited at least once every 12 months or at least once within the life of the activity, whichever is shorter.
External Audits are also scheduled on the "Audit Schedule" and may be included for information on the "Approved Suppliers List." The schedules shall ensure that all elements of a major supplier's QA program are audited at least once every three years.
Both audit schedules shall be reviewed periodically to ensure that coverage is maintained. current.
Audits scheduled as described before may be supplemented by additional Audits as deemed neces-sary per the QAM 11.
18.3 Preparation 18.3.1 Audit Plan The Lead Auditor shall prepare and document an "Audit Plan" for each audit. This plan shall identify the audit scope, requirements, audit personnel, activities to be audited, organization to be notified, applicable documents, schedule, and checklists.
18.3.2 Audit Personnel Audit personnel shall be trained, examined, and certified in accordance with the QAM II. Lead Auditors shall be qualified, certified, and independent of any direct responsibility for performance of the activi-ties w.hich they s;hall audit._ C3NS a_udit personnel shall have authority and organizational freedom to make the Audit meaningful and effective.
The audit of the Quality Management department shall be conducted by a qualified Lead Auditor, appointed by the Managing Director, who has no direct responsibility in that area.
GNS-QAPD-001 Rev. 0 Page 32 of 35
18.4 Performance Audits are performed using checklists prepared in accordance with the QAM II. All activities of the scope of an audit shall be evaluated carefully against the requirements referenced in the checklists.
Objective evidence shall be examined and documented by the auditors to verify whether the require-ments referenced in the checklists are implemented.
18.5 Reporting Results of Audits shall be documented in the "Audit Report" in accordance with the QAM II. The audit reports shall include as a minimum:
- description of the audit scope,
- identificatjon of the audit personnel and persons contacted during the audit,
- _summary of audit results, including a statement of the effectiveness of the QA program ele-ments audited, and
- description of each reported adverse audit finding to enable corrective action to be taken by the audited organization.
The content of the Audit Reports shall be made available to the individuals responsible for the organ-ization audited if findings are identified. Audit findings are documented in an "Audit Nonconformance Report" per the QAM 11.
18.6
Response
The individual responsible for the organization or activity audited shall investigate audit findings, es-tablish corrective actions, including measures to prevent recurrence, and notify the Lead Auditor of Corrective Action taken or planned. The Lead Auditor shall evaluate the proposed measures in re-spect of effectiveness, suitability and implementation of corrective action.
18.7 Follow-up Actions Corrective actions are followed up by the Quality System Manager or Lead Auditor to ensure they are accomplished as scheduled.
18.8 Records Audit records shall include Audit Plans, Audit Checklists, Audit Reports, copies of applicable Audit Nonconformance Reports and written replies.
GNS-QAPD-001 Rev. 0 Page 33 of 35
19 Appendix II Chief Executive Officer (CEO)
Strategy Communications and Sales Managing Board Chief Technical Officer (CTO)
Quality Management Chief Financial Officer (CFO)
Finance IT Systems GNS Furctional Organization Quality Direcror I.
I Quality Assurance Quality System Manager Manager I
I II I
[:] I lrap"m' I Document Callbration @]
Control r
Quality Managemeri Organization G S GNS-QAPD-001 Rev. 0 Page 34 of 35
Managing Board Quality Director I
I I
Quality Assurance Quality 9(stem Project Manager Manager Director I
Project Technical Discipli~s Disciplines Generic Project Organization G S I
Commercial Disciplines GNS-QAPD-001 Rev. 0 Page 35 of 35