ML24192A182

GNS-QAPD-001, Rev. 2, Quality Assurance Program Description (QAPD)

ML24192A182
Person / Time
Site:	07100967, 07109383
Issue date:	06/27/2024
From:	Wellnitz S GNS Gesellschaft fur Nuklear-Service mbH
To:	Office of Nuclear Material Safety and Safeguards
References
EPID L-2021-NEW-0002, T-1213-CO-00021 GNS-QAPD-001, Rev 2
Download: ML24192A182 (1)

Text

@GNS Quality Assurance Program Description (QAPD)

Headquarters:

GNS Gesellschaft fur Nuklear-Service mbH (GNS),

Frohnhauser Strasse 67 45127 Essen, Germany Shop:

Shop Mulheim, Kranbahnallee 3 45473 Mulheim an der Ruhr, Germany Document No.:

Revision:

Date of issue:

Responsible for Document:

Prepared by:

Quality System Manager Reviewed by:

Quality Director Reviewed and approved by:

Licensing Manager Approved by:

Managing Director GNS-QAPD-001

, 2 Essen, 20.06.2024 Managing Director of GNS Name Date S. Wellnitz 20.06.2024 U. Schatz Z.tt,, CG.2.4 D. Bussmann

J6. 06 2'1 Dr. J. Schroder 27.a.24 Signature

~~~

GNS-QAPD-001 Rev. 2 Page 1 of 53

@GNS Revision Date Author comment regarding changes; statement of page, if applicable 0

09.07.2020 S. Wellnitz First issue 1

15.05.2023 S. Wellnitz

• Consideration of NUREG-2215 (in particular chapter 15) and partly NEI 11-04A [Revision O]

• Implementation of "Non-Proprietary Request for Additional Infor-mation Docket No. 71-9383; Certificate of Compliance No. 9383; Model No. CASTOR geo69" Remarks by NRC (March. 16th,

2023)

• Supplements/editorial changes in all chapters of the QAPD

• Chapter "Regulatory commitment" added in chapter 1 to 18

• Project Manager tasks added ( corresponding to Project Director) in chapter1.3

• Appendix moved to Part 2, chapter 1 (Generic Project Organiza-tion, Quality Management Organization), or deleted (GNS Func-tional Organization) 2 20.06.2024

• Implementation of "Request for Additional Information; Docket No. 71 -9383; Model No. Castor Geo-69 Package; Certificate of Compliance No. 9383; Revision No. 3"

• Amendment of chapter 17.5 with regulation for applicable codes and standards used in the storage, retention, and maintenance of both electronic and hardcopy quality assurance records.

• Regulation removed in chapter 18.2 that: "All applicable Quality Assurance Program elements shall be audited at least once each year or at least once during the life of the activity, whichever is shorter."

• Amendment of chapter 18.3.2 with regulations for prospective Lead Auditors qualification GNS-QAPD-001 Rev. 2 Page 2 of 53

@GNS Table of Content Statement of Authority......................................................................................... 4 0

Introduction.......................................................................................................... 5 1

Organization........................................................................................................ 8 2

Quality Assurance Program............................................................................... 13 3

Design Control................................................................................................... 16 4

Procurement Document Control........................................................................ 20 5

Instructions, Procedures, and Drawings............................................................. 22 6

Document Control.............................................................................................. 24 7

Control of Purchased Items, Material, Equipment, and Services........................ 26 8

Identification and Control of Items, Materials, Parts, and Components.............. 31 9

Control of Special Processes............................................................................. 33 10 Inspection.......................................................................................................... 34 11 Test Control....................................................................................................... 37 12 Control of Measuring and Test Equipment......................................................... 39 13 Handling, Storage, and Shipping....................................................................... 41 14 Inspection, Test, and Operation status.............................................................. 42 15 Nonconforming Items, Materials, Parts, or Components.................................... 43 16 Corrective Action............................................................................................... 45 17 Quality Assurance Records............................................................................... 46 18 Audits................................................................................................................ 50 GNS-QAPD-001 Rev. 2 Page 3 of 53

@GNS Statement of Authority The GNS Quality Assurance Program (QAP) described in this "Quality Assurance Program Descrip-tion" (QAPD) is applicable to design, procurement, and construction of packaging, equipment and service for processing, transportation, and storage of spent nuclear fuels and radioactive waste pro-vided by GNS.

The QAPD is the top-level policy document that establishes the manner in which quality is to be achieved and presents GNS's overall philosophy regarding achievement and assurance of quality.

Implementing documents assign more detailed responsibilities and requirements and define the or-ganizational interfaces involved in conducting activities within the scope of the QAP.

The Managing Board is responsible to establish overall expectations for the direction, development, the effective implementation, and for support of the QAP.

The Managing Board assigns one Managing Director (MD) represented by the Chief Technical Officer (CTO). The MD establishes overall expectations for effective implementation of the quality assurance program and is responsible for obtaining the desired end result. Compliance with the QAPD and im-plementing documents is mandatory for personnel directly or indirectly associated with implementa-tion of the QAP. The assigned MD delegates the responsibility for the establishment, training, admin-istration, and enforcement of the 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 line responsi-bility for assuring compliance with this statement of authority.

The MD charges all personnel involved in activities affecting quality with the responsibility of upholding and abiding by the Quality Assurance requirements.

The members of the Quality Management Department are authorized sufficient freedom to identify quality problems; initiate, recommend or provide solutions; verify implementation of solutions; and control further processing of service(s) or delivery of a nonconforming item, deficiency or unsatisfac-tory condition until proper disposition has been completed. They are independent from production costs and schedules.

While it is the responsibility of everyone at GNS to assure that quality and reliability objectives are achieved, the overall responsibility for the development, maintenance and assurance of the imple-mentation of the QAP has been assigned to the QD, who reports directly to the MD of GNS.

All personnel assigned to operations subject to the requirements of this program shall be required to familiarize themselves with the policies and objectives set forth in that program. They shall be respon-sible for executing those policies, explicitly or implied, pertinent to their assignments.

Date GNS-QAPD-001 Rev. 2 Page 4 of 53

{g2)GNS O

Introduction The company GNS Gesellschaft fur Nuklear-Services mbH (GNS) supplies packaging, equipment and services for processing, transportation, and storage of spent nuclear fuels and radioactive waste.

This Quality Assurance Program Description (QAPD) addresses specifically the activities at its head-quarters in Essen and the fabrication at its Shop Mulheim 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 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-cessfully offers its products and services for 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 ago.

Today, the CASTOR family with its different, continuously developed series is an internationally re-nowned trademark and synonym for nuclear safety, reliability and innovation.

The Quality Assurance Program Description (QAPD) is the top-level policy document that establishes the quality assurance policy and assigns major functional responsibilities for activities conducted by or for GNS. The QAPD describes the methods and establishes quality assurance (QA) and adminis-trative controls". The QAPD is based on the requirements and guidance of ASME NQA-1-2008, NQA-1 a-2009 Addenda, and NQA-1-2015 "Quality Assurance Requirements for Nuclear Facility Applica-tions," Parts I and II as identified in this document. It complies with the requirements of the Code of Federal Regulations (10 CFR) Part 71 "Packaging and Transportation of radioactive Material", Sub-part H "Quality Assurance" and Part 72 "Licensing Requirements for the independent Storage of Spent Nuclear Fuel, High-Level radioactive Waste, and reactor-related greater than Class C Waste", Sub-part G "Quality Assurance".

Procedures and instructions that control activities will be developed prior to commencement of those activities. Procedures establish practices for certain activities which are common to all GNS organi-zations performing those activities so that the activity is controlled and carried out in a manner that meets QAPD requirements. Procedures specific to a site, organization, or group establish detailed implementation requirements and methods, and may be used to implement policies or be unique to particular functions or work activities.

GNS-QAPD-001 Rev. 2 Page 5 of 53

@GNS The requirements of Standard Review Plans (SRPs) NUREG-2215 (for applications for storage under 10 CFR 72) and NUREG-2216 (for applications for transportation under 10 CFR 71 ) are satisfied by the application and submission of the SAR as well as by the preparation of this QAPD.

0.1 Scope / Applicability:

The QAPD applies to activities affecting the quality and performance of safety-related structures, sys-tems, and components, including, but not limited to:

Design Purchase Fabrication Handling Shipping Storage Cleaning Assembly Inspection Testing Operation Maintenance Repair Modification of components of packaging / sec Safety-related structures, systems, and components (SSCs) are identified by GNS' design docu-ments. The technical aspects of these items are considered when determining program applicability, including, as appropriate, the item's design safety function.

The policy of GNS is to assure a high degree of availability and reliability of the nuclear plant while ensuring the health and safety of its workers and the public. To this end, selected elements of the QAPD are also applied to certain equipment and activities that are not safety-related, but support safe, economic, and reliable plant operations, or where other NRC guidance establishes quality as-surance requirements. Implementing documents establish program element applicability.

The definitions provided in ASME NQA-1-2008, NQA-1 a-2009 Addenda, and NQA-1-2015 Part I, Section 400, apply to select terms as used in this document.

GNS-QAPD-001 Rev. 2 Page 6 of 53

@)GNS 0.2 Definitions and Abbreviations CGD CGDI DSS GNS IEC ISO QAP QAPD QAPS SAR SSC Commercial Grade Dedication Commercial Grade Dedication Item Dry Storage System GNS Gesellschaft fur Nuklear-Service mbH International Electrotechnical Commission International Organization for Standardization Quality Assurance Program Quality Assurance Program Description Quality Assurance Program Supplement Safety Analysis Report Structures, systems, and components that are important to safety. See 10 CFR 72.3.:

Structures, systems, and components important to safety means those features of the independent spent fuel storage installation (ISFSI), monitored retrievable storage installation (MRS), and spent fuel storage cask whose functions are:

( 1)

(2)

(3) to maintain the conditions required to store spent fuel, high-level radioactive waste, or reactor-related greater than Class C (GTCC) waste safely; to prevent damage to the spent fuel, the high-level radioactive waste, or re-actor-related GTCC waste container during handling and storage; or to provide reasonable assurance that spent fuel, high-level radioactive waste, or reactor-related GTCC waste can be received, handled, packaged, stored, and retrieved without undue risk to the health and safety of the public.

GNS-QAPD-001 Rev. 2 Page 7 of 53

@GNS 1

Organization 1.1 General This chapter describes the structure, interrelationships, and areas of functional responsibility and au-thority for all organizational elements that will perform activities related to quality and safety.

The assignment of responsibility for the overall QAP in no degree relieves line management of its responsibility for the achievement of quality. GNS ensures that high-level management is responsible for documenting and promulgating the QA policies, goals, and objectives, and that this management level maintains a continuing involvement in QA matters.

Representative Organization Charts are presented in Figures 1-1, and 1-2. A Generic Project Organ-ization Chart is provided to show that, for any specific project undertaken by GNS, independence is maintained by the Quality Management function (see figure 1-1 ).

The Quality Management Organization Chart shows the basic distribution of responsibilities under the Quality Director (see figure 1-2).

The main positions that have QA responsibilities and authority are described below. Detailed func-tional descriptions are (to be) determined in the GNS ' QAP.

Qualification requirements for the principal QA management positions are described so as to demon-strate management and technical competence commensurate with the responsibilities of these posi-tions.

The following chapters describe the reporting relationships, functional responsibilities, and authorities for all functions.

Managing Director 1 ************************~~~:i~********ll-** -** -** -** -*** _ ** _ ** _. ~ ____

--i Director I

Quality Assura nee Manager I

I Quality System Manager I

Project Disciplines Project Director/ Manager Technical Disciplines Generic Project Organization Figure 1-1:

Generic Project Organization I

Commercial Disciplines GNS-QAPD-001 Rev. 2 Page 8 of 53

surance

===I Quality As Man ager

[:] I,~,~oo, I Quality Director I

Quality System Manager I

Document Cali brat ion Control Quality Management Organization Figure 1-2:

Quality Management Organization 1.2 Quality Assurance Responsibilities and Authorities

(@)GNS I=

Le ad itor Aud GNS is managed by a Managing Board, which is responsible for establishing overall expectations for the direction, development, implementation, and support of the QAP.

The Managing Board assigns one Managing Director to enforce the QAP. The Managing Director delegates the responsibility for the establishment, training, administration, and enforcement of the GNS QAP 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 QAP and can direct and control the organization's QAP, effectively ensure conformance to quality requirements, and remain sufficiently independent of undue influences and responsibilities of schedules and costs.

Individuals or groups responsible for defining and controlling the content of the QAP and related man-uals have appropriate organizational position and authority, as well as the management level respon-sible for final review and approval.

The Quality Director reviews the status, adequacy, and implementation of the QAP at least annually and reports this status to the Managing Director. He may delegate any of the functions assigned to him to another individual who is part of the Quality Management Department, but he shall retain the responsibility for accomplishment of the function.

QA functions performed by GNS, QA organization or delegated to other organizations that will provide controls to ensure implementation of the applicable elements of the QA criteria are identified and GNS-QAPD-001 Rev. 2 Page 9 of 53

@GNS described.

The Quality Management Department, which assumes line responsibility is independent to all other organizations within GNS.

Hence, it is independent from the pressure of cost and scheduling considerations insofar as QAP matters are concerned.

The Quality System Manager is responsible for the Quality System related topics. The Quality As-surance Manager is responsible for the Quality Assurance related topics.

The extent of QA controls to be identified by the QA staff in combination with the line staff and to depend on the specific activity or item complexity and level of importance to safety shall be deter-mined.

1.3 Quality Assurance Responsibilities for Specific Projects GNS provides clear management controls and effective lines of communication between GNS

• QA organization and suppliers to ensure proper direction of the QAP and resolution of QA-related prob-lems.

Functional Divisions are to be established in accordance with the distribution of tasks.

Divisional Directors are responsible for their assigned domain, reporting directly to the Managing Director.

The implementation of Quality Assurance throughout the various divisions for the design, procure-ment, fabrication, operation, and services at GNS must, therefore, be considered the direct responsi-bility of the organization performing the work and cannot be considered the sole domain of any single Quality Assurance group.

The operational organization of a specific project or task is based on the functional organization of GNS and the specific project organization. The requirements on the management of the projects is determined within the QAP.

The organizational structure of a

project may vary depending upon the nature, scale, and complexity of the work, and assigned personnel may be formed by employees from a single or different organizations, depending on the extent of the project or task.

For accomplishment of a specific project or task, functional management may assign an individual to be responsible for all aspects of the job and to manage the efforts of personnel working on the project, whether they report directly to or through a functional organization. For projects affecting more than one technical division, a Project Director (PD)/ Project Manager (PM) is assigned by the MD. The PD/PM, whoever is assigned, has the overall responsibility for the quality, technical and commercial aspects of projects throughout planning, direction, compliance with technical require-ments, procurement, and fabrication activities for its project. The PD/PM may assign managers that are matrixed from their respective functional organizations.

When a specific project is planned, a Project Organization is formed for that project, taking personnel and disciplines from the functional organization. The quality requirements for the project are identified within a Quality Project Manual which is developed specifically for that project.

GNS-QAPD-001 Rev. 2 Page 10 of 53

@GNS 1.4 Delegation of work Individuals who are assigned specific responsibilities may delegate performance of the activity tooth-ers reporting to them provided they are qualified, certified, and/or authorized as applicable.

The delegation of responsibility must be properly documented, and the responsibility shall remain with the assigned individual.

1.5 Authority to Stop Work Designated QA individuals or organizations have the responsibility and authority, delineated in writing, to stop unsatisfactory work and control further processing, delivery, or installation of nonconforming material.

This extends to off-site work performed by suppliers furnishing safety-related materials and services to GNS.

1.6 Quality Assurance Organizational Independence Persons and organizations performing QA functions have direct access to management levels that will ensure accomplishment of quality-affecting activities.

Persons or organizations charged with the development, enforcement, or measurement of the ade-quacy and effectiveness of the QAP have the authority and organizational freedom necessary to ef-fectively discharge those responsibilities. Such 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 solutions,

• 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.

Conformance to established requirements shall be verified by individuals or groups who do not have direct responsibility for performing the work being verified.

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 quality assurance functions and/or to resolve any dis-putes.

GNS-QAPD-001 Rev. 2 Page 11 of 53

@GNS

1. 7 Interface Control GNS identifies onsite and offsite organizational elements that will function under the purview of the QAP and the lines of responsibility.

Where more than one organization is involved in the execution of activities, the responsibilities, inter-faces, and authority of each organization shall 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.

1.8 Regulatory Commitment In establishing its organizational structure, GNS commits to compliance with NQA-1-2008, NQA-1a-2009 Addenda, and NQA-1-2015, Requirement 1 as well as 10 CFR 71, Subpart H, 71.103, and 10 CFR 72, Subpart G, 72.142.

GNS-QAPD-001 Rev. 2 Page 12 of 53

@)GNS 2

Quality Assurance Program 2.1 General This chapter describes the documentation, planning, implementation, and maintenance of GNS, OAP to provide the appropriate level of control over activities and SSCs consistent with their relative im-portance to safety.

The OAP is based on the requirements and guidance of ASME NQA-1-2008, NQA-1a-2009 Addenda, and NQA-1-2015 "Quality Assurance Requirements for Nuclear Facility Applications," Parts I and II as identified in this document. It complies with the requirements of the Code of Federal Regulations (10 CFR) Part 71 "Packaging and Transportation of radioactive Material", Subpart H "Quality Assur-ance" and Part 72 "Licensing Requirements for the independent Storage of Spent Nuclear Fuel, High-Level radioactive Waste, and reactor-related greater than Class C Waste", Subpart G "Quality Assur-ance".

SSCs, items, and attributes important to safety are identified. For establishing the appropriate level of quality assurance related to items and services a proper classification shall be applied. Assigning accurate quality assurance requirements to items and services involves classifying each item or service as "important to safety" (S) or "not important to safety" (NS),

grouping the items and services into categories (A, B, C or D), and specifying the applicable level of QA effort for each category.

For the evaluation and documentation of the safety classification of each item or service a Safety Classification Form shall be used. Procedure is provided for this process of graded approach.

Items or services that are designed, manufactured, or procured under the OAP are classified using the "Graded approach to classify items and services" according to NUREG/CR-6407.

Supplier documents for agreement with OAP provisions and ensure implementation of a program meeting the QA criteria shall be reviewed by GNS.

As mentioned above, quality requirements for a specific project are identified in a Quality Project Manual (QPM) which is developed for that project. A QPM does not establish new quality require-ments. Rather, it provides a roadmap to show how the quality requirements in the OAP will be imple-mented in that particular project.

Activities important to safety are accomplished using appropriate production and test equipment, suit-able environmental conditions, applicable codes and standards, and proper work instructions.

2.2 Indoctrination and Training of Personnel involved in activities affecting Quality Responsibilities for implementing the major activities addressed in the QA manuals are designated.

Trained, qualified personnel within the organization is assigned to determine that functions delegated to contractors are properly accomplished.

GNS-QAPD-.001 Rev. 2 Page 13 of 53

@GNS Indoctrination, training, and qualification programs fulfill the following criteria:

• instruction of personnel responsible for performing activities affecting quality as to the purpose, scope, and implementation of the quality-related manuals, instructions, and procedures

• training and qualification in the principles and techniques of the activities being performed for per-sonnel performing activities affecting quality

• maintenance of the proficiency of personnel performing quality-affecting activities by retraining, reexamining, and recertifying

• preparation and maintenance of documentation of completed training and qualification

• qualification of personnel in accordance with accepted codes and standards.

2.3 Training, Qualification and Certification of Inspection and Test Personnel The Quality Assurance Manager is responsible for performing documenting the indoctrination and training of GNS's Inspection and Test Personnel. Provision is established for the Qualification of In-spection and Test Personnel. Inspection and Test Personnel shall be re-certified at periodic inteNals not to exceed 3 years. Any person who has not performed Inspection or Testing activities in his qual-ified area for a period of 1 year shall be reevaluated by a re-determination of his required capability.

2.4 Training and Qualification of Nondestructive Examination Personnel GNS's NOE personnel performing NOE activities on Items is trained, qualified and certified. Provisions are made, which describes the requirements for education, training, examination and certification.

Qualification is based on SNT-TC-1 A.

2.5 Training and Qualification of Audit Personnel Audit Personnel is formally qualified and certified.

The Quality Director is responsible for the training, qualification, and certification of audit personnel.

Provisions are established. A list of qualified and certified audit personnel is maintained by the Quality System Manager.

2.6 Management Review The effectiveness of the QAP shall be assessed regularly. The management (above and beyond the QA organization) regularly assesses the scope, status, adequacy, and compliance of the QAP to the requirements of 10 CFR Part 71 and 72.

A frequent appraisal of program status by the management through reports, meetings, and audits is GNS-QAPD-001 Rev. 2 Page 14 of 53

@GNS performed as well as performance of a periodic assessment that is planned and documented with corrective actions identified and tracked.

The Quality Director shall evaluate the adequacy and effectiveness of the program 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 documents this review including his overall expec-tations 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 ad-ditional corrective actions if required.

2.7 Regulatory Commitment In establishing qualification and training programs, GNS commits to compliance with NQA-1-2008, NQA-1a-2009 Addenda, and NQA-1-2015, Requirement 2 as well as 10 CFR 71, Subpart H, 71.105, and 10 CFR 72, Subpart G, 72.144.

GNS-QAPD-001 Rev. 2 Page15of53

@GNS 3

Design Control 3.1 General This chapter describes the approach GNS will use to define, control, and verify the design and devel-opment of transport packages, DSS, and related equipment.

Design measures to be selected and reviewed for suitability of application of materials, parts, equip-ment, and process that are important to safety, are described in this chapter.

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.

All design activities are under the responsibility of the Design Manager or Equipment Manager, respectively.

This chapter addresses the overall requirements 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 determined.

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 maintenance 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 authorities, and shall be documented.

After satisfactory coordination, review and approval of all design inputs from the various sources, a design specification shall be prepared as the central internal document for subsequent design activi-ties.

The applicable regulatory requirements and design bases into specifications, drawings, written pro-cedures, and instructions shall be correctly translated. GNS specifies quality standards in the design documents and control deviations and changes from these quality standards.

GNS-QAPD-001 Rev. 2 Page 16 of 53

(@)GNS 3.3 Design Process Written procedures are established to identify and control the authority and responsibilities of all indi-viduals or groups responsible for design reviews and other design verification activities.

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. Further, applicable documents to be generated during the design process, including the follow-ing, are specified as:

• Technical reports

• Parts lists

• Drawings

• Material and test specifications

• Fabrication specification For the selection of suitable materials, parts, equipment, and processes for SSCs important to safety valid industry standards and specifications are used.

In parallel to the above mentioned design process the qualification and/or identification of the appli-cable supply chain (e. g. NQA-1 qualified supplier, CGDI, QAPS) on basis of the graded approach chosen, is taking part.

3.4 Design Analyses The design analyses shall be coordinated, including engagement of the preparation of the respective documentation in a planned and controlled manner.

GNS shall review designs to ensure that design characteristics can be controlled, inspected, and tested and that inspection and test criteria are identified.

GNS establishes both internal and external design interface controls. These controls include review, approval, release, distribution, and revision of documents involving design interfaces with participating design organizations.

Prior the application of computer programs used for the design analyses shall be verified and vali-dated according to the respective construction code.

Design review can be performed by a less experienced person (as an example, confirmation that the correct computer code has been used is part of design verification). Design review includes confirma-tion of the numerical accuracy of computations and the accuracy of data input to computer codes.

GNS-QAPD-001 Rev. 2 Page 17 of 53

@GNS 3.5 Design Verification GNS shall properly select and perform design verification processes such as design reviews, alterna-tive calculations, or qualification testing. When a test program is used to verify the adequacy of a design, GNS shall use a qualification test of a prototype unit under adverse design conditions.

Design verifications (i.e., confirmation that the design of the SSC is suitable for its intended purpose) are completed by an individual with a level of skill at least equal to that of the original designer.

Design verification shall be performed by persons other than those performing design review. Individ-uals or groups responsible for design verification must not include the original designer.

The suitability of any materials, parts, and equipment for the intended application shall be reviewed before selecting such items that are standard, commercial (off-the-shelf), or have been previously approved for a different application.

All errors and deficiencies in the design or the design process that could adversely affect SSCs, items, and attributes important to safety shall be documented. Adequate corrective actions shall be imple-mented, including root cause evaluation of significant errors and deficiencies, to preclude repetition.

3.6 Change Control Design and specification changes are subject to the same design controls and the same or equivalent approvals that were applicable to the original design.

Design changes, whether during the design phase or after final design, are prescribed and controlled.

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,

• Correct "as-built" drawings and documentation will be maintained, and

• Any changes in the design that could impact the Certificate of Compliance for a packaging will be submitted for approval by the NRC prior to implementation.

3.7 Interface Control Design team members are selected on a project-related basis. The Project Manager is responsible for overall project coordination. Internal and external design interfaces are established and main-tained.

GNS-QAPD-001 Rev. 2 Page 18 of 53

@GNS 3.8 Documentation and Records In addition to design output documents, design documentation shall also comprise less formal docu-mented design input.

Such design input may be gained, for example, according to the list of technical requirements and boundary conditions, records or memos from kick-off or other steering meetings. Further documenta-tion or records may comprise design specification, relevant conceptual documents, drafts, or rec-ord/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.

3.9 Regulatory Commitment In establishing its program for design control and verification, GNS commits to compliance with NQA-1-2008, NQA-1a-2009 Addenda, and NQA-1-2015, Requirement 3 as well as 10 CFR 71, Subpart H, 71.107, and 10 CFR 72, Subpart G, 72.146.

GNS-QAPD-001 Rev. 2 Page 19 of 53

{82)GNS 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.

Documents used to procure SSCs or services shall include or reference applicable design bases and other requirements necessary to ensure adequate quality.

Suppliers identified shall be controlled as described in chapter 7 of this QAPD.

Procedures are established that clearly delineate the sequence of actions to be accomplished in the preparation, review, approval, and control of procurement documents.

4.2 Content of the Procurement Documents Procurement documents in regard to the Construction Code chosen or by implementation of a QAPS or procurement by CGD 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 Qualified personnel shall review and concur with the adequacy of quality requirements stated in pro-curement documents and ensure that the quality requirements are correctly stated, inspectable, and controllable.

The review shall include:

there are adequate acceptance and rejection criteria, and the procurement document has been prepared, reviewed, and approved in accordance with QAP requirements.

Procurement documents shall identify the applicable QA requirements that should be compiled and described in the supplier's QAP and to ensure that the applicant reviews and concurs with the suppli-er's QAP. If subtier suppliers are also used, the supplier's QAP shall apply to the subtier suppliers.

GNS-QAPD-001 Rev. 2 Page 20 of 53

@GNS Procurement documents shall contain or reference the regulatory requirements, design bases, and other technical requirements.

Procurement documents shall identify the documentation (e.g., drawings, specifications, procedures, inspection and fabrication plans, inspection and test records, personnel and procedure qualifications, and chemical and physical test results of material) to be prepared, maintained, and submitted to GNS for review and approval.

Procurement documents shall identify records to be retained, controlled, and maintained by the sup-plier and those records to be delivered to GNS before use or installation of the hardware.

Procurement documents shall specify the procuring agency's right of access to the supplier's facilities and records for source inspection and audit.

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.

Changes and revisions to procurement documents shall be subject to the same or equivalent review and approval as the original documents.

4.5 Regulatory Commitment In establishing controls for procurement, GNS commits to compliance with NQA-1-2008, NQA-1a-2009 Addenda, and NQA-1-2015, Requirement 4 as well as 10 CFR 71, Subpart H, 71.109, and 10 CFR 72, Subpart G, 72.148.

GNS-QAPD-001 Rev. 2 Page 21 of 53

@) GNS 5

Instructions, Procedures, and Drawings 5.1 General This chapter defines GNS, procedures for ensuring that activities affecting quality will be prescribed by, and performed in accordance with, documented instructions, procedures, or drawings of a type appropriate for the circumstances.

All activities affecting the quality of services provided, or items and systems constructed and delivered to-or by GNS, are performed in accordance 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.

Activities affecting quality are prescribed and accomplished in accordance with documented instruc-tions, procedures, or drawings.

5.2 Processing Approval of these documents, and revisions thereto, is performed and maintained by the appropriate levels of management. In regard to the OAP the Quality System Manager is responsible.

The document control matrix shall be applied.

Provisions shall be established that clearly delineate the sequence of actions to be accomplished in the preparation, review, approval, and control of instructions, procedures, and drawings.

Instructions, procedures, and drawings specify the methods for complying with each of the applicable QA criteria.

Instructions, procedures, and drawings shall include quantitative acceptance criteria (such as dimen-sions, tolerances, and operating limits) as well as qualitative acceptance criteria (such as workman-ship samples) as verification that activities important to safety have been satisfactorily accomplished.

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.

The QA organization shall review and concur with the procedures, drawings, and specifications re-lated to inspection plans, tests, calibrations, and special processes, as well as any subsequent changes to these documents.

GNS-QAPD-001 Rev. 2 Page 22 of 53

@GNS 5.4 Regulatory Commitment In establishing procedural controls, GNS commits to compliance with NQA-1-2008, NQA-1a-2009 Addenda, and NQA-1-2015, Requirement 5 as well as 10 CFR 71, Subpart H, 71.111, and 10 CFR 72, Subpart G, 72.150.

GNS-QAPD-001 Rev. 2 Page 23 of 53

(@)GNS 6

Document Control 6.1 General This chapter describes GNS ' procedures for preparing, issuing, and revising documents that specify quality requirements or prescribe activities affecting quality.

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.

All controlled documents can be identified throughout GNS and GNS subsidiaries.

6.2 Controlled documents and their distribution All documents to be controlled under this subsection are identified, including, as a minimum:

design specifications design and fabrication drawings and parts lists procurement documents QPM 's design criteria documents fabrication, inspection, and testing instructions and test procedures.

Procedures are established to control the review, approval, and issuance of documents, and any subsequent changes, before release to ensure that the documents are adequate and applicable qual-ity requirements are stated.

The identification of individuals or groups responsible for reviewing, approving, and issuing docu-ments and subsequent revisions to the documents are determined.

Documents shall be available at the location where the activity is performed.

Controlled documents and revisions thereto are identified by a unique identification.

GNS and its subsidiaries use different methods to manage the flow of documents prescribing quality requirements or activities affecting quality. However, all authorized personnel at GNS and its subsid-iaries 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, 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 doc-uments prescribing quality requirements or activities affecting quality shall be identified with title, doc-ument no. and revision. Quality personnel and projecUteam personnel identified in the Quality Project GNS-QAPD-001 Rev. 2 Page 24 of 53

@GNS 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.

Revisions shall be handled as described above with respect to distribution of the original controlled documents.

Document revisions shall receive review and approval by the same organizations that performed the original review and approval or by other qualified responsible organizations designated by GNS.

Approved changes shall be included in instructions, procedures, drawings, and other documents be-fore the change is implemented.

Obsolete or superseded documents shall be controlled to prevent inadvertent use.

A master list (or equivalent) shall be established to identify the current revision number of instructions, procedures, specifications, drawings, and procurement documents, to avoid the use of superseded documents the list shall be updated and distributed to predetermined, responsible personnel.

6.4 Regulatory Commitment In establishing provisions for document control, GNS commits to compliance with NQA-1-2008, NQA-1 a-2009 Addenda, and NQA-1-2015, Requirement 6 as well as 10 CFR 71, Subpart H, 71.113, and 10 CFR 72, Subpart G, 72.152.

GNS-QAPD-001 Rev. 2 Page 25 of 53

{82)GNS 7

Control of Purchased Items, Material, Equipment, and Services 7.1 General This chapter describes GNS ' procedures for controlling purchased items, material, equipment, and services to ensure conformance with specified requirements.

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 going to be designed, manufactured, or procured are classified using the "Graded approach to classify items and services".

7.2 Supplier Evaluation and Selection Qualified personnel shall evaluate the supplier's capability to provide services and products of ac-ceptable quality before the award of the procurement order or contract. QA and engineering groups shall participate in the evaluation of those suppliers providing critical items and services important to safety, including a definition of the responsibilities for each participating group.

Evaluation of suppliers shall consider establishing the following provisions (if applicable):

• the supplier's capability to comply with the elements of the QA criteria that are applicable to the type of items, material, equipment, or service being procured

• review of previous records and performance of suppliers that have provided similar articles or ser-vices of the type being procured

• a survey of the supplier's facilities and QAP to assess the capability to supply a product that meets applicable design, manufacturing, and quality requirements.

Results of supplier evaluations shall be documented and filed.

Adequate surveillance of suppliers during fabrication, inspection, testing, and shipment of items, ma-terials, equipment, and components shall be planned and performed in accordance with written pro-cedures to ensure conformance to the purchase order requirements. The procedures provide the following information:

• instructions that specify the characteristics or processes to be witnessed, inspected or verified, and accepted; the method of surveillance and the extent of documentation required ; and those respon-sible for implementing these instructions

• procedures for audits and surveillance to ensure that the supplier complies with the quality require-ments (surveillance should be performed for SSCs for which verification of procurement require-ments cannot be determined upon receipt).

Suppliers are selected from the Approved Suppliers 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.

GNS-QAPD-001 Rev. 2 Page 26 of 53

@GNS 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 72 requirements.

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.

Periodic audits, independent inspections, or tests are performed to ensure the validity of the suppliers' certificates of conformance.

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 Supplier shall furnish the following records to GNS:

• documentation that identifies the purchased items, material, equipment and services and the spe-cific procurement requirements (e.g., codes, standards, and specifications)

• documentation that identifies any procurement requirements that have not been met and a de-scription of any non conformances designated "accept as is" or "repair".

The documents prepared or provided by the supplier shall be submitted to GNS and distributed in a controlled manner. A supplier's generated set of documents includes i.e.:

• Certified Material Test Reports,

• Certificate of Compliance,

• Certificate of Conformance,

• Calibration Records,

• Fabrication/Casting plans, and/or

• Drawings.

Review and acceptance of these documents are established and, as a minimum, and will be under-taken by a responsible QA individual.

GNS-QAPD-001 Rev. 2 Page 27 of 53

@)GNS 7.5 Acceptance of Items or Services The method of acceptance for items and services received shall be specified by GNS.

The QAP contains provisions for determining the extent to which supplier surveillance will be per-formed during fabrication, assembly, modification, repair, and shipment, to ensure conformance with purchase order requirements.

A receiving inspection of supplier-furnished items, material, equipment, and services shall be per-formed to ensure fulfillment of the following criteria:

• proper identification of the items, material, component, or equipment in a manner that corresponds with the identification on the purchasing and receiving documentation

• inspection of items, material, components, equipment, and acceptance records and judgment of their acceptability in accordance with inspection instructions before installation or use

• availability of inspection records or certificates of conformance attesting to the acceptance of items, material, components, and equipment before installation or use

• identification of the inspection status for accepted items and ensuring associated markings are attached before the accepted items are forwarded to a controlled storage area or released for installation or further work.

The effectiveness of suppliers' quality controls shall be assessed at intervals consistent with the im-portance to safety, complexity, and quantity of the SSCs procured.

7.6 Control of Suppliers Nonconformances Nonconformances shall be identified by GNS or the supplier.

Nonconformances identified by the supplier shall 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.

GNS-QAPD-001 Rev. 2 Page 28 of 53

@GNS 7.7 Commercial Grade Items and Services In the QAP Procedures are established to be able to perform under Commercial grade requirements for items and services.

The dedication is an acceptance process to provide reasonable assurance that a commercial grade item or service will successfully perform its intended safety function and, in this respect, is deemed equivalent to an item or service provided under the requirements of NQA-1. This assurance is achieved by identifying the appropriate critical characteristics of the item or service and verifying their acceptability.

The basis of the dedication (Commercial Grade Dedication - CGD) is a technical evaluation which includes:

Identification of Item or service for procurement as a Commercial Grade and determine if the item or service is eligible for Commercial-Grade Dedication Determination of safety functions and performance requirements of the item I service Identification of critical characteristics and acceptance criteria Definition of dedication methods

- Special Tests, Inspections, or Analyses

- Commercial Grade Survey

- Source Verification

- Acceptable Performance Record.

Dedication plans may be developed for a specific item, service, or for a generic group of items or services. Dedication requirements shall be included in applicable procurement and technical docu-ments as necessary to support the dedication.

The documentation of the commercial grade dedication process shall be traceable to the items or services and shall include the following documents, depending on the applicable dedication methods:

1. Procurement documents

2. Technical evaluation

3. Dedication plan

4. Test, inspection or analysis reports including results

5. Commercial Grade Survey reports

6. Source verification reports

7. Performance records.

The equivalence of the methods choosen to the requirements of NQA-1 shall be confirmed.

GNS-QAPD-001 Rev. 2 Page 29 of 53

@GNS 7.8 Counterfeit, Fraudulent, and Suspect Items (CFSI)

Inspection activities shall be performed in accordance with procurement documents and process con-trol documents. If these activities disclose counterfeit and/or fraudulent items, or items which are sus-pect, they shall be considered as nonconforming until the conformance to specified requirements can be verified.

7.9 Records Records are established and maintained to indicate the performance of the following functions:

a) supplier evaluation and selection b) acceptance of items and services c) supplier nonconformances to procurement document requirements, including their evaluation and disposition.

Documents that are prepared or provided by the supplier shall be submitted to GNS and distributed in a controlled manner.

7.10 Regulatory Commitment In establishing controls for purchased items and services, GNS commits to compliance with NQA 2008, NQA-1a-2009 Addenda, and NQA-1-2015, Requirement 7, as well as 10 CFR 71, Subpart H, 71.115, and 10 CFR 72, Subpart G, 72.154.

GNS-QAPD-001 Rev. 2 Page 30 of 53

{82)GNS 8

Identification and Control of Items, Materials, Parts, and Components 8.1 General This chapter describes GNS ' provisions for identifying and controlling items, materials, parts, and components to ensure that incorrect or defective SSCs are not used.

Procedures are established to identify and control items, materials, parts, and components.

8.2 Identification methods The method of marking, the content of marking, and other marking specifics for items to be received during fabrication and assembly, and if applicable, installation and use are described in provisions.

Specific controls shall be used to document their identification.

The location and method of identification must not affect the fit, function, or quality of the item being identified.

Identification requirements shall be determined during the generation of specifications and design drawings.

The identification of materials and parts for items important to safety shall be traceable to the appro-priate documentation (such as drawings, specifications, purchase orders, manufacturing and inspec-tion documents, deviation reports, and physical and chemical mill test reports)

The correct identification of all items, materials, parts, and components before releasing them for fabrication, assembly, shipping, and installation shall be verified and documented.

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 stored items Identification shall be maintained either on the item or on records traceable to the item to preclude the use of incorrect or defective items.

In case GNS or GNS subsidiaries procure more items than requested in the customer's purchase order as spare parts, the QAP details the requirements for maintaining the identification of these items.

GNS-QAPD-001 Rev. 2 Page 31 of 53

@GNS 8.3 Regulatory Commitment In establishing provisions for identification and control of items, GNS commits to compliance with NQA-1-2008, NQA-1 a-2009 Addenda, and NQA-1-2015, Requirement 8 as well as 10 CFR 71, Subpart H, 71.117, and 10 CFR 72, Subpart G, 72.156.

GNS-QAPD-001 Rev. 2 Page 32 of 53

@GNS 9

Control of Special Processes 9.1 General This chapter describes the controls established by GNS to ensure the acceptability of special pro-cesses for which direct inspection is generally impossible or disadvantageous and that the proposed controls are performed by qualified personnel using qualified procedures and equipment in accord-ance with specified requirements.

The following are examples of areas and items that may be addressed to support implementation of the quality criteria: welding, heat treatment, nondestructive testing.

9.2 Process Control Special processes shall be controlled by qualified procedures, instructions, drawings, checklists, trav-ellers, or other appropriate means of GNS or respective suppliers. These documents shall contain or reference qualification requirements, in accordance with applicable codes and standards and specifi-cations. They shall include acceptance criteria, and other special requirements for personnel and equipment, as well as conditions necessary for accomplishment of the process (e.g. proper equip-ment, controlled parameters of the process, specified environment, calibration requirements).

Only qualified personnel shall perform responsibly special processes in accordance with qualified procedures, instructions (or the equivalent) with recorded evidence of verification.

9.3 Records Records shall be appropriately maintained for the qualified personnel, processes, and equipment of each special process.

Current qualification records of procedures, equipment, and personnel associated with special pro-cesses are established, filed, and kept.

9.4 Regulatory Commitment In establishing measures for the control of special processes, GNS commits to compliance with NQA-1 -2008, NQA-1 a-2009 Addenda, and NQA-1-2015, Requirement 9 as well as 10 CFR 71,

Subpart H, 71.119, and 10 CFR 72, Subpart G, 72.156.

GNS-QAPD-001 Rev. 2 Page 33 of 53

@GNS 10 Inspection 10.1 General The Licensee, the Certificate Holder, and as GNS the applicant for CoC shall establish and execute a program for inspection of activities affecting quality by or for the organization performing the activity, to verify conformance with the documented instructions, procedures, and drawings for accomplishing the activity.

Inspections are performed by qualified individuals who were not involved in the performing or direct supervision of the work to be inspected.

An inspection program is established, documented, and conducted that effectively verifies the con-formance of quality-affecting activities with requirements in accordance with written, controlled proce-dures.

Inspection procedures, instructions, and checklists provide the following details:

• identification of characteristics and activities to be inspected

• identification of the individuals or groups responsible for performing the inspection operation

• acceptance and rejection criteria

• a description of the method of inspection

• procedures for recording evidence of completing and verifying a manufacturing, inspection, or test operation

• identification of the recording inspector or data recorder and the results of the inspection operation.

Inspection procedures or instructions shall be used with the necessary drawings and specifications when performing inspection operations.

10.2 Hold Points Hold points for witnessing or inspecting by a designated GNS inspector shall be identified and handled within the traveller/lTP. For Hold Points, work shall only proceed after the designated inspector has completed an the respective inspection step.

10.3 Inspection Planning The responsible design function shall specify the characteristics of the inspection, including the 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 inspection processes shall be based on standard statistical methods with engineering approval.

GNS-QAPD-001 Rev. 2 Page 34 of 53

@GNS 10.4 In-Process Inspection Inspections of items under construction or otherwise in process shall be performed as necessary to verify quality. If inspection of processed items is impossible or disadvantageous, indirect control by monitoring of processing methods, equipment, and personnel shall be provided.

10.5 Final Inspection Final inspections include a records review of the results and resolution of nonconformances identified by prior inspections.

Modifications, repairs, and replacements shall be inspected in accordance with the original design and inspection requirements or acceptable alternatives.

Individuals or groups who will perform receiving and process verification inspections are identified.

Demonstration that these individuals or groups have sufficient independence and qualifications is required.

Inspectors are qualified in accordance with applicable codes, standards, and company training pro-grams. Inspector qualifications and certifications are kept current.

10.6 Receiving Inspection When receiving inspection is used, purchased items shall be inspected as necessary to verify con-formance to specified requirements, taking into account source verification and audit activities and the demonstrated quality performance of the Supplier.

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 shall be planned and executed to ensure the continued performance of their required functions.

10.8 Inspection Records Inspection Records shall identify the following as a minimum:

• Items inspected,

• date of Inspection,

• Inspector,

• type of observation, GNS-QAPD-001 Rev. 2 Page 35 of 53

@GNS

• results of acceptability,

• reference to information on action taken in connection with Nonconformances, and

• document no. and revision used in performance of the activity.

All Inspection documentation shall be properly maintained.

10.9 Regulatory Commitment In establishing inspection requirements, GNS commits to compliance with NQA-1-2008, NQA-1a-2009 Addenda, and NQA-1-2015, Requirement 10 as well as 10 CFR 71, Subpart H, 71.121, and 10 CFR 72, Subpart G, 72.160.

GNS-QAPD-001 Rev. 2 Page 36 of 53

@)GNS 11 Test Control 11.1 General This chapter describes GNS, provisions for tests to verify that SSCs conform to specified require-ments and will perform satisfactorily in 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.

Test results shall be documented and evaluated against the test requirements and acceptance crite-ria.

11.2 Test Requirements Test programs to demonstrate that the item will perform satisfactorily in service in accordance with written, controlled procedures are established, documented and conducted.

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.

A test program/specification shall include or reference such things as test objectives, required records, prerequisites, acceptance criteria, and monitoring requirements.

Written test procedures incorporate or reference the following information:

• requirements and acceptance limits contained in applicable design and procurement documents

• instructions for performing the test

• test prerequisites

• mandatory inspection hold points

• acceptance and rejection criteria

• methods of documenting or recording test data results.

GNS-QAPD-001 Rev. 2 Page 37 of 53

@GNS 11.4 Test Results Test results are documented by a qualified, responsible individual or group and their acceptability is evaluated. The measures should ensure that testing of the SSC occurs under conditions that will be present during normal and anticipated off-normal operations.

Test results shall be documented, evaluated, and maintained as a QA record to ensure that test re-quirements have been satisfied.

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.

11.6 Regulatory Commitment In establishing provisions for testing, GNS commits to compliance with NQA-1 -2008, NQA-1a-2009 Addenda, and NQA-1-2015, Requirement 11 as well as 10 CFR 71, Subpart H, 71.123, and 10 CFR 72, Subpart G, 72.162.

GNS-QAPD-001 Rev. 2 Page 38 of 53

@GNS 12 Control of Measuring and Test Equipment 12.1 General This Chapter describes GNS

• provisions to ensure that tools, gauges, instruments, and other meas-uring and testing devices used in activities affecting quality are properly identified, controlled, cali-brated, and adjusted at specified intervals to maintain accuracy within necessary limits.

GNS uses accredited calibration services and laboratories in accordance to ISO/IEC 17025, ILAC or MRA.

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.

The MTE must be listed in the "List of Measuring and Test Equipment," which ensures that measure-ment and testing is performed with adequate accuracy.

12.3 Calibration and Control Documented procedures describe the calibration technique and frequency, maintenance, and control of all measuring and test equipment (instruments, tools, gauges, fixtures, reference and transfer standards, and nondestructive test equipment) that will be used in the measurement, inspection, and monitoring of SSCs important to safety.

Measuring and test equipment are identified and traceable to the calibration test data and are listed in the list of MTE's.

Labels, tags, or documents are used for measuring and test equipment to indicate the date of the next scheduled calibration and to provide traceability to calibration test data.

Measuring and test instruments are calibrated at specified intervals on the basis of the required ac-curacy, precision, purpose, degree of usage, stability characteristics, and other conditions that could affect the accuracy of the measurements.

Reference and transfer standards shall be traceable to nationally recognized standards. Otherwise the basis for calibration shall be documented where national standards do not exist, e. g. manufac-turer's recommendation.

Calibration is subcontracted to approved suppliers as mentioned in chapter 12.1. In case MTE needs to be purchased, GNS shall provide necessary specifications.

GNS-QAPD-001 Rev. 2 Page 39 of 53

@)GNS 12.3.1 Nonconformances in MTE 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 removed 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 Records shall be established and maintained to indicate calibration status and the capability of meas-uring and test equipment to satisfactorily perform its intended function.

The results of subcontracted calibration shall be reviewed for acceptance.

Calibration records shall be identified, traceable, and maintained as QA records.

The complete status of all items under the calibration system shall be documented and maintained.

12.5 Regulatory Commitment In establishing provisions for control of measuring and test equipment, GNS commits to compliance with NQA-1-2008, NQA-1a-2009 Addenda, and NQA-1-2015, Requirement 12 as well as 10 CFR 71,

Subpart H, 71.115, 10 CFR 71, Subpart H, 71.125, and 10 CFR 72, Subpart G, 72.164.

GNS-QAPD-001 Rev. 2 Page 40 of 53

@GNS 13 Handling, Storage, and Shipping 13.1 General This chapter describes GNS

• provisions to control the handling, storage, shipping, cleaning, and preservation of SSCs in accordance with work and inspection instructions to prevent damage, loss, and deterioration.

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, Equipment, Operators and Marking or Labeling Measures to establish and accomplish special handling, preservation, storage, cleaning, packaging, and shipping requirements are defined in the QAP which contains measures in accordance with de-sign and specification requirements to preclude damage, loss, or deterioration by environmental con-ditions (such as temperature or humidity).

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, such as cranes, shall be specified in instructions, and used and controlled as necessary to ensure safe and adequate handling.

They shall be inspected and tested in accordance with the work safety requirements at annual inter-vals and properly documented. All operators shall be experienced and trained in the use of the equip-ment.

13.4 Regulatory Commitment In establishing provisions for handling, storage, and shipping, GNS commits to compliance with NQA-1-2008, NQA-1a-2009 Addenda, and NQA-1-2015, Requirement 13 as well as 10 CFR 71, Subpart H, 71.127, and 10 CFR 72, Subpart G, 72.166.

GNS-QAPD-001 Rev. 2 Page 41 of 53

@GNS 14 Inspection, Test, and Operation status 14.1 General This chapter describes GNS

• provisions to control the inspection, test, and operating status of SSCs to prevent the inadvertent use of SSCs or bypassing of inspections and tests.

The QA organization is responsible for the following as a minimum:

• the inspection and test status of items shall be recognizable throughout fabrication

• procedures shall be established to control the application and removal of inspection and welding stamps and operating status indicators (such as tags, markings, labels, and stamps)

• procedures which control the bypassing of required inspections, tests, and other critical operations are under the cognizance of the QA organization

• the organization responsible for documenting the status of nonconforming, inoperative, or malfunc-tioning SSCs and for identifying the item to prevent inadvertent use are specified.

14.2 Regulatory Commitment In establishing measures for control of inspection, test and operating status, GNS commits to compliance with NQA-1-2008, NQA-1a-2009 Addenda, and NQA-1-2015, Requirement 14 as well as 10 CFR 71, Subpart H, 71.129, and 10 CFR 72, Subpart G, 72.168.

GNS-QAPD-001 Rev. 2 Page 42 of 53

15 Nonconforming Items, Materials, Parts, or Components 15.1 General This chapter describes GNS ' provisions to control the use or disposition of nonconforming items, materials, parts, or components that do not conform to GNS

• requirements to prevent their inadvertent use or installation.

Nonconformances are handled in accordance within the QAP and if contractually requested under the regulation of 1 0CFR21.

Procedures to control the identification, documentation, tracking, segregation, review, disposition, and notification of affected organizations regarding nonconforming items, materials, parts, components, services, or activities are established.

An adequate documentation to identify nonconforming items shall be prepared. It shall describe the nonconformance, its disposition, and the related inspection requirements. Such measures also pro-vide for adequate documentation and include signature approval of the disposition.

15.2 Identification Nonconforming items, materials, parts, or components shall be clearly identified.

Nonconforming measurement and test equipment (MTE) is determined in chapter 12.

Personnel with the responsibility and authority for a disposition and closeout of nonconformance is designated.

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.

Nonconforming items are identified as discrepant until properly dispositioned and closed out.

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.

The acceptability of reworked or repaired items, materials, parts, and SSCs shall be verified by rein-specting and retesting the item as originally inspected and tested or by using a method that is at least GNS-QAPD-001 Rev. 2 Page 43 of 53

@GNS equal to the original inspection and testing method. The relevant inspection, testing, rework, and re-pair procedures shall be documented.

Nonconformance reports designated "use as is", "repair" or "others" are made part of the inspection records and forwarded to the PM for a technical justification and after that to the customer.

Nonconformance reports are periodically analyzed to show quality trends and help identify root causes of nonconformances. Significant results shall be reported to responsible management for re-view and assessment.

15.5 Regulatory Commitment In establishing measures for nonconforming materials, parts, or components, GNS commits to compliance with NQA-1-2008, NQA-1a-2009 Addenda, and NQA-1-2015, Requirement 15 as well as 10 CFR 71, Subpart H, 71.131, and 10 CFR 72, Subpart G, 72.170.

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@GNS 16 Corrective Action 16.1 General This chapter describes GNS' provisions to ensure that conditions adverse to quality such as failures, malfunctions, deficiencies, deviations, defective material and equipment, and nonconformances, are promptly identified and corrected, and that measures are taken to preclude recurrence.

Significant conditions adverse to quality shall be evaluated in accordance with established procedures to assess the need for corrective action.

This corrective action system is also extended to the Suppliers.

16.2 Documentation Significant conditions adverse to quality, as well as the root causes of the conditions, and the correc-tive actions taken to remedy and preclude recurrence of the conditions shall be documented. This information shall be reported to the MD as the cognizant level of management for review and assess-ment.

Nonconformances and Corrective actions based on Audits are documented by the Lead Auditor on an audit nonconformance report.

16.3 Follow up Follow-up activities to verify proper implementation of corrective actions and close out the corrective action documentation in a timely manner shall be conducted.

16.4 Evaluation for Management Review The Quality System Manager shall review the Nonconformance Reports and Corrective Action Re-ports, internal and external audit reports, customer audits and other areas for evaluation at least an-nually to determine if there are any conditions or trends adverse to quality.

This review is documented in the Management Review Report. A summary of Corrective Actions is submitted to the Managing Director at least once per year for his review.

16.5 Regulatory Commitment In establishing measures for corrective action, GNS commits to compliance with NQA-1-2008, NQA-1 a-2009 Addenda, and NQA-1-2015, Requirement 16 as well as 10 CFR 71, Subpart H, 71.133, and 10 CFR 72, Subpart G, 72.172.

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{82)GNS 17 Quality Assurance Records 17.1 General This chapter defines GNS's provisions for identifying, retaining, retrieving, and maintaining records that document evidence of the control of quality for activities and SSCs important to safety.

Both electronic and hardcopies are retained.

17.2 Generation of Records 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.

QA records include e. g. operating logs, results of reviews, inspections, tests, audits, and material analyses; monitoring of work performance; qualification of personnel, procedures, and equipment; and other documentation such as drawings, specifications, procurement documents, calibration pro-cedures and reports, design review and peer review reports, nonconformance reports, and corrective action reports.

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.

Records shall be identified and retrievable.

The requirements and responsibilities for record preparation, transmittal, retention (such as duration, location, fire protection, and assigned responsibilities), and maintenance subsequent to completion of work shall be consistent with applicable codes, standards, and procurement documents.

Where applicable, inspection and test records shall contain the following information:

a description of the type of observation the date and results of the inspection or test information related to conditions adverse to quality identification of the inspector or data recorder evidence as to the acceptability of the results action taken to resolve any noted discrepancies.

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(@)GNS 17.4 Classification Records are classified as lifetime or non permanent (Table 17-1 ).

This classification also takes into account the requirements of the NQA-1 req. 17 and Owner/Cus-tomer requirements.

17.5 Receipt, storage, retention, and maintenance of records Each organization is responsible for organizing and implementing receipt controls for temporary and permanent storage.

Storage, retention, and maintenance of both electronic and hardcopy quality assurance records shall be performed on the basis of:

ISO 9001 ISO 27001 IAEA GSR-2, requirement 8 BAM-GGR 011 and KTA 1401, chapter 11.

The requirements of RG 7.10 Rev. 3 and RG 1.28 Rev. 6 are consistent with the above-mentioned codes and standards.

Records received from suppliers shall be reviewed for completeness, correctness, and legibility.

In case customer, jurisdictional, or regulatory requirements define a different record retention period than described within the QAP, such deviated retention periods shall be described in the Quality Pro-ject Manual.

GNS retains these records for at least 3 years beyond the date when the licensee, certificate holder, and applicant for a Certificate of Compliance last engage in the activity for which the quality assurance program was developed. If any portion of the Quality Assurance Program, writ-ten procedures or instructions is superseded, GNS shall retain the superseded documents for 3 years after it is superseded.

GNS-QAPD-001 Rev. 2 Page 47 of 53

(@)GNS Quality Assurance Record LT/NP QAM NP 3 QAM-P NP 3 ASL NP10 ITP NP10 List of Technical Requirements and Boundary Conditions NP 10 LAD NP 10 Design Specification incl. attachments NP10 Design Report incl. attachments LT Safety Report incl. attachments LT Computer Program VerificationNalidation LT Fabrication Specification incl. attachments LT Test Specification/Work Instruction LT PSL LT Procurement Requisition NP6 Request for Quotation NP10 Quotation (with followed PO)

NP6 Purchase Order NP6 Supplier document LT Fabrication documentation (Supplier documentation) incl. FTP, LT NCR Manufacturing documentation (GNS) incl. FTP, NCR LT Audit/Survey Report LT CAR NP 3 Calibration Record Until recalibrated Personal qualification record NP 3 LT= L1fet1me Record; NP= Nonpermanent Record [years]

Table 17-1 : Quality Assurance records - classification and retention time Records are maintained and protected from degradation, damage or loss by the following measures:

restricted access permanent preservation by regulation of climate, air and light to prevent damage from mold, pol-lutants or sunlight structural and technical measures to protect against fire and water damage.

GNS-QAPD-001 Rev. 2 Page 48 of 53

(@)GNS GNS' record storage facilities (archive) are constructed, located, and secured to prevent destruction of the records by fire, flood, theft, and deterioration by environmental conditions (such as temperature or humidity). The facilities are maintained by, or under the control of, GNS throughout the life of the transport package, DSS or the individual product.

Filed records can be retrieved from storage or GNS databases by qualified personnel in a controlled manner.

An unacceptable deterioration of the electronic recoding media which could occur during the specified retention period is ensured by the use of PDF/A file format and redundant storage or separate archiv-ing of data or appropriate data backup.

17.6 Regulatory Commitment In establishing provisions for records, GNS commits to compliance with NQA-1-2008, NQA-1a-2009 Addenda, and NQA-1-2015, Requirement 17 as well as 10 CFR 71, Subpart H, 71.135, and 10 CFR 72, Subpart G, 72.174.

GNS-QAPD-001 Rev. 2 Page 49 of 53

@GNS 18 Audits 18.1 Scope This chapter describes GNS ' provisions for planning and scheduling internal and external audits to verify compliance with all aspects of the QAP and to determine the effectiveness of the overall pro-gram.

To achieve the following objectives technical and QAP audits are performed:

• comprehensive, independent verification and evaluation of procedures and activities affecting qual-ity

• verification and evaluation of the suppliers' QAPs, procedures, and activities.

Audits shall objectively assess the effectiveness and proper implementation of the QAP and address the technical adequacy of the activities being conducted.

18.2 Scheduling Regular audits are scheduled on the basis of the status and importance to safety of the activities being audited. Audits are initiated early enough to ensure effective QA during design, procurement, and contracting activities.

Internal Audits are scheduled in a manner to provide coverage and coordination with ongoing QAP activities.

I All applicable Quality Assurance Program elements shall be audited at least once each year or at least once during the life of the activity, whichever is shorter.

External Audits shall also be scheduled and be identified on the "Approved Suppliers List."

The schedules shall ensure that all elements of a major supplier's QAP are audited at least once every three years.

Both audit schedules are reviewed periodically to ensure that coverage is maintained current.

Audits scheduled as described before may be supplemented by additional Audits as deemed neces-sary.

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.

GNS-QAPD-001 Rev. 2 Page 50 of 53

@GNS 18.3.2 Audit Personnel Audit personnel is appropriately qualified, and certified. Lead Auditors is qualified, certified, and inde-pendent of any direct responsibility for performance of the activities which they shall audit.

Prospective Lead Auditors, with adequate education and industry experience, may satisfy the Lead Auditor qualification requirement

• of participating in a minimum of five quality assurance audits within a period of three years prior to the date of qualification or alternatively

• demonstrating the ability to properly implement the audit process,

• effectively organize and report results, and

• participate in at least one nuclear audit within the year preceding the date of qualification subject to review and acceptance by the MD/ QD.

GNS audit personnel has the authority and organizational freedom to make the Audit meaningful and effective.

The audit of the Quality Management department is conducted by a qualified and certified Lead Au-ditor, who has no direct responsibility in that area.

18.4 Performance Audits are performed in accordance with written procedures using checklists prepared in accordance with the QAP.

Qualified personnel performing these audits must not have direct responsibility for the achievement of quality in the areas being audited.

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 requirements referenced in the checklists are implemented.

18.5 Reporting Results of Audits are documented in the "Audit Report".

The audit reports include as a minimum:

• description of the audit scope,

• identification of the audit personnel and persons contacted during the audit,

• summary of audit results, including a statement of the effectiveness of the QAP elements audited, and

• description of each reported adverse audit finding to enable corrective action to be taken by the audited organization.

GNS-QAPD-001 Rev. 2 Page 51 of 53

@)GNS The content of the Audit Reports shall be reviewed by management with responsibility in the area audited.

Audit findings are documented in an "Audit Nonconformance Report".

18.6

Response

The individual responsible for the organization or activity audited shall investigate audit findings, es-tablish appropriate corrective action.

Corrective action should ensure that auditing organizations schedule and conduct appropriate follow up to ensure that the corrective action is effectively accomplished.

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.

The Lead Auditor shall evaluate the proposed measures in respect of effectiveness, suitability, and implementation of corrective action using audit nonconformance reports within the following workflow as determined:

Identification of the nonconformity Cause analysis Corrective action to be done check of documentation concerning corrective action taken evaluation of effectiveness of measures/ no recurrence confirmation of completion of corrective action.

18.8 Records Audit records include Audit Plans, Audit Checklists, Audit Reports, copies of applicable Audit Non-conformance Reports and written replies.

Audit deficiency data shall be analyzed to recognize trends.

The resulting reports, indicating quality trends and the effectiveness of the QAP, shall be given to management for review, assessment, corrective action, and follow up.

18.9 Regulatory Commitment In establishing the independent audit program, GNS commits to compliance with NQA-1-2008, NQA-GNS-QAPD-001 Rev. 2 Page 52 of 53

@GNS 1a-2009 Addenda, and NQA-1-2015, Requirement 18 as well as 10 CFR 71, Subpart H, 71.137, and 10 CFR 72, Subpart G, 72.176.

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