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Procurement of nuclear safety related items or services

T/AST/077 – Issue 1

Issue date:

26 August 2009

Review date:

26 August 2013

Open Government Status:

Fully Open

Approved by :

A N Hall

1 Purpose and scope

1.1 The primary responsibility for safety of a nuclear installation rests with the Licensee. It is HSE's policy, promulgated through Nuclear Site Licence Condition 17 'Quality Assurance', that the Licensee makes and implements adequate quality assurance arrangements in all matters which may affect safety. A fundamental element of these arrangements is the control of procurement such that appropriate levels of quality assurance, quality control and inspection are applied by all organisations within the supply chain.

1.2 This approach is designed to ensure that what is purchased complies with the purchaser's requirements, including the technical specification which, for nuclear safety related items or services, may have been assessed and considered adequate by the NII.

1.3 This Technical Assessment Guide (TAG) applies to all items or services procured in support of new civil reactor build, modifications and upgrade to existing nuclear facilities. It includes items manufactured for the construction of a new civil reactor in advance of a nuclear site licence application, or before a Licensee organisation is in place. See Annex 1 for definitions applicable to this document.

1.4 The established and preferred model within the UK nuclear regulatory framework is that the purchaser at the head of the supply chain is a UK nuclear Licensee. The Licensee is expected to carry out adequate and appropriate oversight, and acceptance of items or services being supplied or undertaken on its behalf.

1.5 This TAG informs regulatory assessment of supply chain arrangements which are particularly important to the supply of items or services significant to nuclear safety designated for use in the UK. It also provides guidance for regulatory inspection during the manufacturing stages. It considers the following:

1. Procurement of items or services in support of construction, manufacture, repair, replacement, modification of plant and equipment. Of particular relevance is the relationship between the purchaser (usually the Licensee) and suppliers with respect to the adequacy of the technical requirements documents and the controls applied to all aspects of manufacture or fabrication. It is expected that a graded approach will apply with significant oversight and involvement by the purchaser. For certain items, the design code may specify particular responsibilities for the purchaser and suppliers.
2. Procurement in support of new civil reactor build, where the reactor vendor may choose to place orders for long lead time items in advance of an order from the future reactor operator/future Licensee. Of particular relevance is the relationship between the future civil reactor operator/future Licensee, the reactor vendor and the vendor's suppliers with respect to the adequacy of the technical requirements documents and the controls applied to all aspects of manufacture, fabrication or provision of services.

1.6 A future civil reactor operator may not be licensed until after orders have been placed for long lead time items. Under this scenario the NII would expect future civil reactor operators/future Licensees to act as an 'intelligent customer', to assure themselves that procured items or services meet the technical specification, and that adequate documentation is available to justify the safety of the procured items.

1.7 Throughout the design process, significant assurance activities should be undertaken to ensure that the design meets the requirements of the purchaser and applicable codes or standards (plus any additional regulatory requirements). Assurance activities should ensure that the design is realised through the procurement process and delivered by the supply chain.

1.8 For new civil reactor build, the technical requirements of the contract between the purchaser and supplier for items or services must, amongst other things, reflect the findings of the NII's technical assessment work.

2 Relationship to nuclear site licence and other relevant legislation

The following UK legal and other requirements are applicable to procurement of items or services:

2.1 The Health and Safety at Work Act (1974)

• Section 2 requires every employer to provide and maintain plant and systems of work that are, so far as is reasonably practicable, safe and without risk to health.
• Section 6 requires that any person who designs, manufactures, imports or supplies any article for use at work:
  • Must ensure, so far as is reasonably practicable, that the article is designed and constructed as to be safe and without risk to health when properly used;
  • Must carry out or arrange for the carrying out of such testing and examination as may be necessary to comply with the above duty;
  • Must provide adequate information about the use for which it is designed and has been tested to ensure that, when put to use it will be safe and without risk to health.

2.2 The Construction (Design and Management) Regulations (2007)

These regulations place duties on clients, designers (including engineers), and principal contractors of construction projects of a certain duration.

2.3 Nuclear Site Licence Conditions:

The following Nuclear Site Licence Conditions are applicable:

• LC 6 – Documents, Records, Authorities and Certificates
• LC 14 – Safety Documentation
• LC 17 – Quality Assurance
• LC 19 – Construction or Installation of New Plant
• LC 20 – Modification to Design of Plant Under Construction
• LC 21 – Commissioning
• LC 22 – Modification or Experiment on Existing Plant

3 SAPs, WENRA reference levels and IAEA safety standards addressed

Safety Assessment Principles (SAPs)

3.1 The Safety Assessment Principles for Nuclear Facilities [PDF 1.93MB] (SAPs) (2006 Edition, Revision 1) provides a framework to guide regulatory decision-making in the nuclear permissioning process. It is supported by Technical Assessment Guides (TAGs) which further aid the decision-making process. The following principles are of relevance to this technical assessment guide:

• MS.1 – Leadership. Identifies the need for an organisation to have a Quality Management System.
• EKP.4 – Safety Function. Defines the Safety Function(s) to be delivered within a facility.
• ECS.1 – Safety Categorisation. Describes the categorisation of Safety Functions, identification of structures, systems and components that deliver safety functions and selection of appropriate codes and standards.
• EMC.3 to 5, EMC.13 to 16, EMC.17 to 20 – Integrity of Metal Components and Structures. These SAPs identify the requirements to demonstrate the integrity of metal components and structures.

3.2 Technical Assessment Guides (TAGs)

• T/AST/049 – Principles for the Assessment of a Licensee's "Intelligent Customer Capability". This TAG addresses aspects of contractor selection, oversight and control.
• T/AST/033 – Records Storage. This TAG addresses the requirements for management of records.

WENRA Reactor safety reference levels

3.3 The following issue in The Western European Nuclear Regulators Association (WENRA) Reactor Harmonisation Working Group Reference Levels, 2008 [PDF 375KB] is relevant, although there is no specific reference level related to procurement per se:

• Issue G – Safety Classification Systems and Components (SSCs). This specifies that SSCs important to safety shall be identified and classified on the basis of their importance to safety.

IAEA Safety standards

3.4 The IAEA Safety Standards (Requirements and Guides) were the benchmark for the revision of the SAPs in 2006 and are recognised by NII as relevant good practice. They should therefore be consulted, where relevant, by the assessor, although it should be appreciated that they are design standards rather than regulatory standards. The main IAEA Safety Standard of relevance is the Safety Requirements – The Management System for Facilities and Activities, Safety Standards Series No. GS-R-3 [PDF 298KB], IAEA, 2006; which defines the requirements for establishing, implementing, assessing and continually improving a management system. Section 5, on Process Implementation, has under the heading "Generic Management System Processes" requirements on (inter alia) the control of documents, the control of products, the control of records and purchasing, with which this TAG is consistent.

3.5 This requirements standard is supported by a Safety Guide - Application of the Management System for Facilities and Activities, Safety Standards Series No. GS-G-3.1 [PDF 743KB], IAEA, 2006.

3.6 A further Safety Requirements standard of relevance is Safety of Nuclear Power Plants: Design, Safety Standards Series No. NS-R-1 [PDF 201KB], IAEA, 2000; which provides a basis for the safety function categorisation of systems, structures and components. Its Annex lists safety functions for PWRs and BWRs of which safety functions 11 and 16 relate to the pressure boundary.

4 Advice to inspectors

Background

4.1 It is expected that organisations procuring items or services with nuclear safety significance will have and operate adequate documented procedures which are part of their quality management arrangements (e.g. a quality programme). It is the responsibility of the organisation at the top of the supply chain to ensure that its supplier organisations operate quality arrangements which are appropriate and consistent with the safety significance of the items or services being procured.

4.2 This principle also applies to supplier organisations which, in turn, should ensure that their suppliers operate appropriate quality assurance systems. The level of NII scrutiny is dependent on the safety significance of the items or services being procured (see Annex 2). This scrutiny might include confirmation of the adequacy of the supplier's quality programme and/or be part of the manufacturing or construction inspection activities identified via the supplier's quality plan arrangements.

4.3 The aim of this guide is to help Inspectors assess whether organisations procuring items or services have adequate arrangements in place to assure the quality of those items and services, and confirm they have control of the supply chain.

4.4 The NII's expectation is that the application of assurance activities should be proportionate to the nuclear safety significance of the items or services being procured. The following sub-sections identify the key aspects of the procurement process.

Purchaser

4.5 The purchaser may be the Licensee where a site is already licensed, or a future civil reactor operator/eventual Licensee in the case of new civil reactor build. Where a site licence is not in place or a Licensee has not been fully established, the purchaser should provide the same level of assurance as would be expected of a Licensee.

4.6 The Inspector should consider:

1. If it is clear who is or will ultimately be responsible for providing assurance that procured items with nuclear safety significance meet the required specification;
2. If the purchaser understands its responsibilities, either under a nuclear site licence, or as a supplier to a future nuclear site Licensee, and has satisfactory assurance arrangements in place;
3. If the purchaser has sufficient skills and resources within its own organisation to maintain control and oversight of the procurement process for items or services.

Selection of suppliers

4.7 Purchasers are expected to ensure that supply organisations have the organisational and technical capabilities to deliver items or services, including construction, in line with their requirements. Suppliers' organisational arrangements should include a documented quality management programme appropriate to the items or services being supplied which meets the requirements of a national or international QA standard or equivalent.

4.8 As part of the supplier selection process, usually by a combination of questionnaire, audit, inspections, certification to a recognised QA standard and/or continuing surveillance, the purchaser should ensure that suppliers also vet their own suppliers to ensure that appropriate quality management arrangements are in place and are being applied throughout the supply chain. This approach should not preclude purchasers from evaluating any level of the supply chain or carrying out any inspection or surveillance activity at these levels when work is in progress.

4.9 The purchaser should monitor the performance of selected suppliers for, amongst other things, compliance with their quality management arrangements, and take corrective actions which may include withdrawal of contract and/or removal from the purchaser's approved suppliers list if contract performance is unacceptable. The selection and use of suppliers is the responsibility of the purchaser who should retain responsibility for the quality of items or services provided. The NII's expectation is that the purchaser has and retains sufficient intelligent customer capability to specify and monitor manufacturing, fabrication and testing, and accept for technical adequacy the items or services being purchased.

4.10 The Inspector should consider:

If the purchaser has satisfactory arrangements in place through which it can show that:

1. It is in control of the procurement process for items or services;
2. It maintains adequate oversight of work carried out by the supply chain.

Procurement documents

4.11 The purchaser should prepare technical specifications that fully describe the items or services to be procured together with other contractual documents. This combination of requirements should identify appropriate levels of quality assurance to be applied. These should include, where applicable, quality planning, quality control, inspection and testing, and should fully detail the records package required to be supplied with the item or service.

4.12 For items or services which are the principal means of ensuring nuclear safety, additional assurance and inspection arrangements may be required which go beyond basic compliance with established design codes and standards. NII may wish to assess, and find acceptable, the technical specification used as the basis for procurement prior to procurement action taking into account any additional requirements. Annex 3 illustrates the preferred model for procurement of primary circuit pressure boundary components which require the highest level of assurance.

4.13 Design codes and standards can set standards for construction/manufacturing progress. These need to be taken into account in the development of the technical specification. Additionally, at the pre-contract stage, the purchaser will need to ensure that prospective suppliers fully understand that the items or services being procured are the principal means of ensuring nuclear safety.

4.14 Where technical specifications are prepared for nuclear safety significant items or services by contractors on behalf of the purchaser, these should be reviewed by staff from the purchaser's organisation who are competent to confirm that the specifications properly reflect the design intent and as such meet safety case requirements. This must be carried out before contract placement.

4.15 On receipt of the purchase order, the supplier should carry out a review of the contract documentation to ensure that it can fulfil all the technical, procedural and commercial requirements of the contract. For complex and high capital value plant, discussions between the supplier (and sub suppliers) and purchaser should normally have covered these aspects prior to contract placement. The supplier should advise the purchaser of any changes to its (or its sub-suppliers) ability to fulfil the contract as such changes arise.

4.16 The Inspector should consider:

If the purchaser has satisfactory arrangements in place through which it can show that:

1. Technical specifications reflect the design intent and meet safety case requirements;
2. Technical specifications prepared by contractors are reviewed by competent staff from the purchaser's organisation;
3. Appropriate levels of quality assurance are applied to the procurement of items or services significant to nuclear safety;
4. Prospective suppliers fully understand that the items or services being procured are the principal means of ensuring nuclear safety.

Quality plans

4.17 The purchaser should make clear in the contract the extent to which quality plans will be used. Quality plans should be agreed with the purchaser prior to their use. The use of quality plans, developed by the supplier and agreed with the purchaser, is essential to ensure that items are fabricated/manufactured/tested and inspected in a planned and controlled manner and that the required levels of integrity are achieved.

4.18 Quality plans allow the purchaser to check in advance that the supplier has fully understood the detailed requirements of the technical specification, and that the supplier has in place the necessary assurance activities to deliver items that will meet the technical specification. Quality plans also allow the purchaser, second party (supplier), independent third party inspection personnel and, in some instances, the NII, to insert witness points, review points or hold points into the manufacturing sequence.

4.19 Quality plans should show the entire sequence of steps to realise the item or service and details of hold point release. These need to be available for review by involved parties, before work commences and in sufficient time to allow these parties to review and annotate them with hold/witness/review points and/or to question the sequence or referenced documents.

4.20 Quality plans, in identifying the sequence of activities required to satisfy the requirements of the contract, should reference process/fabrication instructions, tests, inspections and clearly identify the records required to be generated and provided to the purchaser. They should provide the facility for signatures to be entered on stage/final completion of the work covered at each element of the plan.

4.21 A completed quality plan should provide the demonstration that all appropriate steps have been taken to deliver the product to purchaser requirements, including details of the organisations involved and references to control documents and appropriate records.

4.22 For complex items that are fabricated/manufactured in stages, there may be several quality plans which support a top level quality plan.

4.23 Generally, a quality plan should identify/reference all those documents which form the purchaser's document package and include such aspects as qualification of personnel, fabrication procedures, material certification and traceability, consumable specification, concessions and rework, manufacture, fabrication instructions, heat treatment records, inspection and test results (including those from the purchaser, second, and third party inspection organisations).

4.24 The Inspector should consider:

If the purchaser has satisfactory arrangements in place to demonstrate that Quality Plans:

1. Are comprehensive and inclusive of the full sequence of steps required to deliver the item or service;
2. Identify hold points and include provision for the NII to witness or review them as appropriate;
3. Are being adhered to and are fully signed off after each step has been completed.

Variations to contract

4.25 The purchaser, as part of its quality arrangements, should operate a change control process. This should ensure that any changes to the contract, including design changes, are properly authorised and the implications for nuclear safety are fully considered prior to implementation of the change. Where these changes impact on the safety case, this may require further assessment by the NII.

4.26 The purchaser should re-approve, where appropriate, supplier documents such as quality plans and manufacturing instructions before a change is implemented. Where changes introduce the use of specialist skills, the purchaser should ensure that the supplier takes appropriate steps to deliver the levels of assurance required.

4.27 The supplier should establish a change control process that will ensure that any changes to contract are properly approved and authorised by the purchaser and the implications on the manufacturing/delivery process including changes to documentation (particularly process quality related, e.g. quality plans) have been fully considered and effected prior to implementation of the change.

4.28 The Inspector should consider:

If the purchaser has a satisfactory change control process in place to demonstrate that:

1. Variations to contract are properly, conceived, communicated, implemented and assessed for nuclear safety implications;
2. Suppliers have notified the purchaser of proposed changes and that they are properly assessed and authorised by the purchaser;
3. Supplier documents e.g. quality plans, manufacturing instructions have been re-approved before a change is implemented.

Competence

4.29 Supply chain organisations should ensure that personnel who carry out work that has an effect on the quality of the procured items are competent (Suitably Qualified and Experienced) to carry out the work assigned, including when variations to work scope are introduced.

4.30 Purchasing organisations should undertake checks to assure themselves that suppliers have competent personnel, particularly those carrying out contract review, fabrication and inspection functions, e.g. coded welders and test engineers. The judgement on competency should be based on qualifications and experience using the organisations' own criteria and any applicable design code requirements for selection, employment and training of employees.

4.31 Arrangements should also include monitoring of individual's performance and corrective action when these are found not to reach the required standard.

4.32 The Inspector should consider:

If the purchasing organisation's arrangements are adequate to:

1. Check and assure themselves that suppliers have sufficient competent personnel;
2. Monitor the performance of individuals.

Deviations

4.33 Deviations (non-conformances) are unplanned departures from the purchaser's requirements and can be identified through a number of devices including inspection, audit or technical query. They can occur at any level within the supply chain.

4.34 The identification, reporting and resolution of deviations should not be seen as negative but as an indication that the achievement of the purchaser's requirements is of prime importance. The control of any deviation from the technical specification is fundamental to the achievement of quality and therefore the integrity of the item.

4.35 All organisations within the supply chain should, as part of their quality management arrangements, operate consistent arrangements (policed by the purchaser) for the categorisation and disposition of deviations.

4.36 Purchasers at each level of the supply chain should ensure that their suppliers have adequate arrangements for the identification, categorisation and disposition of deviations for items or services. These should include obtaining the approval of the purchaser for the deviation in the form of a concession or procedure for re-work, and informing the ultimate purchaser and the NII (via the purchaser at the head of the supply chain) for deviations that are significant to nuclear safety.

4.37 The Inspector should consider:

If the purchaser at the head of the supply chain is able to demonstrate that it has satisfactory arrangements in place at each level of the supply chain which ensure that:

1. All deviations are identified, characterised and formally sanctioned by competent persons with the appropriate delegated authority;
2. Suppliers bring all deviations of nuclear safety significance to the attention of the NII via the purchaser at the head of the supply chain.

Records

4.38 The importance of identification and retention of manufacturing, fabrication and inspection records cannot be overstated as these ultimately support the safety case. These provide the evidence of assurance activities including those carried out by the supplier and sub-suppliers and in some cases the purchaser. Records also provide the NII with evidence of the application of assurance arrangements and are used to demonstrate compliance with the requirements of LC 19 when a nuclear site licence is granted to a reactor operator.

4.39 Records form part of the demonstration that plant and equipment meet the design intent and safety requirements. The identification, generation, completion and retention of records associated with the supply of items or services should form part of the contractual arrangements between purchaser and supplier at all levels of the supply chain.

4.40 The purchaser should identify all the records required to be delivered to the purchaser during or on completion of the contract. Particular attention should be given to material traceability and inspection, test and surveillance activities.

4.41 The Inspector should consider:

1. If the purchaser has put adequate contractual arrangements in place to ensure that relevant records are identified and provided by the supply chain in the correct form and to the required timescale;
2. If the identified records are sufficient to satisfy the requirements of LC19.

Inspection and surveillance activities

4.42 The established and preferred model within the UK nuclear regulatory framework is that the purchaser at the head of the supply chain is a UK nuclear Licensee. Where a site licence is not in place or a Licensee has not been fully established, the purchaser must take on the role and responsibilities of the licensee.

4.43 In this position the purchaser is expected to carry out adequate and appropriate oversight and acceptance of items or services being supplied or undertaken by others on its behalf. It may involve the operation of a certification process which provides authorisations at various stages of manufacture.

4.44 This will necessitate continuing close involvement from the pre-tender stage, and may include surveillance and witnessing of key activities. In some instances this may include inspections using second or independent third party organisations depending, amongst other things, on the nuclear safety significance of the items being procured. This should be planned and executed, in part, by the application of quality plans.

4.45 This approach provides essential levels of assurance which are in addition to that provided through the suppliers' own quality arrangements. It reinforces the status of the purchaser as an intelligent customer particularly with respect to current or future plant ownership.

4.46 In addition to the application of sound quality assurance principles to the procurement process, which should be applied at all the levels of the supply chain, there should be additional and specific purchaser's organisational and technical requirements that need to be met.

4.47 The adequacy of the technical specification as a central element of the contract is essential. The technical specification for the item or service should reflect, where relevant, any assessment work carried out by the NII and be fully in line with the safety case.

4.48 The fulfilment of the technical specification will commit the purchaser to set up organisational and procedural arrangements which may need to be agreed (e.g. for primary pressure parts) with the NII as part of the future Licensee's procurement activities.

4.49 For new civil reactor build, where procurement of long lead items may be undertaken in advance of a nuclear site licence being granted, organisational and procedural arrangements developed as part of the procurement, arrangements must provide equivalent levels of assurance consistent with those that a Licensee would apply if a nuclear site licence was in place. Purchasers should clearly indicate which items or services they consider to have long lead times and detail what organisational and procedural arrangements will be applied to deliver these items or services to adequate levels of assurance, together with an indication of records requirements. These proposals should be fully discussed with the NII prior to any procurement activity commencing.

4.50 In deciding on the levels of assurance, the purchaser should consider the safety significance of the item or service, the level of assurance normally applied to the item or service for its intended use, the code/standard requirements (for agreed and justified departures) and the difficulty of inspection and testing post manufacture or installation. It is important that the NII has access to all parties that are carrying out quality related activities if required. Access will normally be arranged via the Licensee or purchaser.

4.51 Where items or services have been procured by the purchaser prior to a Licensee being in place, or the purchasing organisation is not fully established as a Licensee, the purchaser and eventual Licensee will need to establish arrangements which ensure that the future Licensee acts as an 'intelligent customer' for the supply of those items or services. These arrangements will need to be discussed with the NII. Assurance records should be made available to the NII as required.

4.52 The NII may develop an intervention programme to guide the assessment/inspection of selected arrangements or activities undertaken by purchasers or suppliers within the supply chain. Of particular importance is early engagement with purchasers and review of quality plans.

4.53 The Inspector should consider:

If the purchaser can demonstrate that it has arrangements in place to carry out adequate and appropriate oversight of items or services being supplied or undertaken by others on its behalf by:

1. Identifying a suitable intelligent customer capability (see T/AST/049 'Licensee Use of Contractors and Intelligent Customer Capability');
2. Showing how it selects and appoints individuals to deliver this capability;
3. Establishing a surveillance capability to provide appropriate levels of assurance and monitoring of the supply chain activities.
4. The competence of any Inspection Agency to provide third party assurance and verification of items or services significant to nuclear safety.

Annex 1 - Definitions

1 Licensee

For a nuclear installation licensed under the Nuclear Installations Act 1965 (as amended) the Licensee is responsible for the safety of the installation and the quality assurance arrangements relevant to the nuclear safety of the installation. The Licensee's Quality Assurance arrangements should be reflected in and supported by the QA arrangements of its Contractors and Sub-Contractors. This is achieved via contract arrangements.

2 Items or Services

Items or services referred to in this guidance are those that contribute to nuclear safety including those that provide the principal means of ensuring safety. Items include components, vessels and civil structural components whilst services include design, inspection services and peer review.

3 Purchaser

The purchaser may be the Licensee where a site is already licensed or a future civil reactor operator/eventual Licensee in the case of new civil reactor build. Where a site licence is not in place or a Licensee has not been fully established, the purchaser should provide the same level of assurance as would be expected of a Licensee.

4 Manufacturer/Contractor/Vendor

The organisation that designs, constructs and tests items or services in accordance with a purchaser's order. This term includes the main manufacturer and any sub-contractors. It also encompasses the scenario where design, manufacture, and installation might be carried out by different organisations.

5 Inspection Agency (IA)

The independent body or organisation that verifies that items or services have been designed, constructed and tested in accordance with the technical specification. The IA should have suitable competencies.

For example for Nuclear Steam Supply System components, the Inspection Agency should be accredited within the meaning of ISO 17020, to Type A independence criteria. This is intended to meet the desire for an Independent Third Party Inspection Agent role (NII SAP EMC.18). However, for items or services with less significant impact on safety, second party inspection bodies may be used.

The responsibilities of an Inspection Agency are defined more fully in Annex 3, Section 4.

6 Technical Specification

The Technical Specification defines the system, components and items, as applicable, in sufficient detail to provide a complete basis for the design, manufacture, testing and installation. This is a technical specification document, not a commercial purchase specification.

7 Design Report

The Design Report includes the stress calculations and other data and information in sufficient detail to demonstrate compliance with the appropriate codes and standards. This is done by showing that the applicable stress and other limits and requirements of the chosen design code are met when the system, component or item is subjected to the loading conditions defined in the Design Specification.

The Design Report should be reconciled with all design changes which occur prior to the completion and acceptance of the items described in the Design Report.

8 Design Code

A standard with industry, national or international status, that defines the technical and possibly organisational rules by which an item or process can be described and realised.

9 Suitably Qualified and Experienced Persons for Certifications

Certificate Forms require signatures on behalf of organisations by personnel suitably qualified and experienced (SQEP) for the aspects their signatures cover. In terms of UK qualifications, Chartered Engineer would be appropriate. Equivalent professional qualifications in other countries are acceptable, with the basis for equivalence justified. This applies to Licensee, Manufacturer/ Contractor and Inspection Authority/Agency.

10 Quality Plan

A document or set of documents setting out the specific quality practices, resources and sequence of activities relevant to realisation of a particular component or system. A Quality Plan translates quality policies into operational results. For the current purpose, the 'sequence of activities' aspect (who does what and when) is particularly relevant. Amongst other aspects, a Quality Plan is useful for formalising and co-ordinating the interactions of various organisations, including the IA and the NII, through the identification of witness and hold points.

Annex 2 – Items requiring high Levels of NII involvement with the supply chain

1 Introduction

This annex provides a summary of items and services that warrant high levels of NII involvement through interactions such as agreement of the technical specification prior to contract placement and inspection/surveillance activity during the procurement process.

2 Structural Integrity

1. Pressure system components where the nuclear safety claim is that the likelihood of gross failure is so low it can be discounted (gross failure cannot be tolerated within design provisions),
2. Class 1 components (including those that fall under (a) above),
3. A sample of Class 2 components (the sample to include any Class 2 components that fall under (a) above)
4. A sample of Class 3 components. The sample is expected to be smaller than for Class 2 components (the sample to include any Class 3 components that fall under (a) above).

Note: The above classes are derived from design codes.

3 Control and Instrumentation

Class 1 systems and components and a sample of Class 2 systems and components.

4 Civil Engineering

Class 1 structures and a sample of Class 2 structures and systems.

5 Mechanical Engineering

Class 1 systems and components and a sample of Class 2 systems and components.

Notes, The following notes are applicable to paragraphs 3, 4 and 5 above:

1. NII Safety Assessment Principle (SAP) EKP.4 defines Safety Function. SAPs ECS.1 to ECS.3 deal with categorisation of Safety Functions, identification of structures, systems and components that deliver safety functions and selection of appropriate codes and standards.
2. Class 1, 2 and 3 structures, systems or components are defined as:
   1. Class 1 – any structure, system or component that forms a principal means of fulfilling a Category A safety function;
   2. Class 2 – any structure, system or component that makes a significant contribution to fulfilling a Category A safety function;
   3. Class 3 any other structure, system or component.
3. Category A, B and C functions are defined as:
   1. Category A – any function that plays a principal role in ensuring nuclear safety;
   2. Category B – any function that makes a significant contribution to nuclear safety;
   3. Category C – any other safety function.

Annex 3 – Preferred model for the primary circuit pressure boundary components

1 Introduction

The preferred model for procurement in support of new build or development or maintenance of existing facilities positions the Licensee at the head of the supply chain. However, where the Licensee organisation is not in place or is not fully developed, some or all of the Licensee's responsibilities may be undertaken by the purchaser.

This annex provides examples of organisational roles and responsibilities for the specification, design, manufacture, testing and installation of primary circuit pressure boundary components which represents the highest level of assurance.

The main organisations involved are:

• Licensee/Purchaser
• Manufacturer/Contractor
• Inspection Agency
• Accredited organisation that issues the Licensee's Certificate

The responsibilities of these organisations are as follows:

2 Licensee/Purchaser

The responsibilities of the Licensee/Purchaser are to:

2.1 Document a Quality Assurance Programme in accordance with a national/international standards e.g. IAEA GS-R-3 'The Management System for Facilities and Activities', for submission the NII.

2.2 Obtain a Licensee's "Certificate" to confirm the Licensee's capability to execute its responsibilities. The organisation that issues this certificate to the Licensee should be agreed with the NII. Ideally the Certificate should be issued by an organisation engaged by the Licensee for this sole purpose.

The responsibilities of these organisations are as follows:

2 Licensee/Purchaser

The responsibilities of the Licensee/Purchaser are to:

2.1 Document a Quality Assurance Programme in accordance with a national/international standards e.g. IAEA GS-R-3 'The Management System for Facilities and Activities', for submission the NII.

2.2 Obtain a Licensee's "Certificate" to confirm the Licensee's capability to execute its responsibilities. The organisation that issues this certificate to the Licensee should be agreed with the NII. Ideally the Certificate should be issued by an organisation engaged by the Licensee for this sole purpose.

2.3 Engage one or more Inspection Agencies to fulfil the role described in Section 4 of this annex.

2.4 Certify that the completed installation complies with the design code/technical specifications for the various components/systems. A framework of certification forms is defined in Section 6 of this annex.

2.5 Define in the Technical Specification, those records that are to be included in the lifetime records for the installation and the associated records management arrangements. These will include:

• 2.5.1 Identification of the records to be retained by the Licensee and the Contractor.
• 2.5.2 Arrangements to safeguard and maintain records to be retained by the Licensee and the Contractor.
• 2.5.3 Arrangements which ensure that Contractor's records are transferred to the Licensee if the Contractor is no longer willing or able to retain the records.

2.6 Evaluate and audit the Quality Assurance arrangements employed by Contractors (and where appropriate, including Sub-Contractors) for design, manufacture and installation of nuclear safety related pressure equipment.

2.7 Establish the Design Code version to be used and define this in the Design Specification.

2.8 Prepare, review and certify the Technical Specifications, Design Reports and Certification Forms and designate authorised personnel to carry out those duties.

2.9 Classify equipment in accordance with applicable safety criteria, define the resulting applicable Design Code, and define the acceptance criteria to be applied to load/design limit combinations.

2.10 Designate overpressure protection requirements and location for each component or system.

2.11 Provide a report that explains and justifies the overpressure protection arrangements.

2.12 Provide adequate structures, foundations and auxiliary systems for pressure equipment.

2.13 Make available to the NII those documents which the Inspection Agency are required to endorse and such documentation as is necessary for the Inspection Agency to fulfil its responsibilities.

2.14 If not required by the Design Code, agree with the Contractor and Inspection Agency a suitable means of physical identification of components and items.

Items 2.1 – 2.6 cannot be delegated by the Licensee. Items 2.7 to 2.14 may be delegated by the Licensee, provided that the responsibility for compliance remains with the Licensee.

3 Manufacturer/Contractor

The responsibilities of the Manufacturer/Contractor are to:

3.1 Prepare, review, approve and certify the Technical Specification, Design Report and Certification Forms (see Section 6 of this annex), where these responsibilities have been delegated by the Licensee, and to submit the certified documents to the Licensee and Inspection Agency as necessary.

3.2 Designate authorised personnel to carry out the certification duties required. Such personnel should not be in the employment of the Inspection Agency. The Contractor must be prepared to justify his arrangements for designation to the Licensee.

3.3 Obtain approval from the Licensee (or the Purchaser in the case of a Sub-Contractor) for its Quality Assurance Arrangements.

3.4 Specify appropriate Quality Assurance Programme requirements to be met by its Sub-Contractors, and to approve its Sub-Contractors Quality Assurance arrangements against these requirements. The Licensee and Inspection Agency shall have the right to participate in the QA approval process and its subsequent audit activities at any level of supply. It is the responsibility of the Contractor to advise the Licensee and the Inspection Agency of approval or audit activities so that participation by their nominated representatives may be agreed in advance of the activity.

3.5 Ensure compliance with the Technical Specification and Design Code.

3.6 Ensure that applicable requirements are effectively applied throughout the supply chain. This shall include, but not be limited to, procurement from its suppliers of Technical Specifications, Design Reports, Certification Forms and other applicable documents.

3.7 Prepare records packages for items being procured including Manufacturer/Contractor Certification Forms and those provided by Sub-Contractors. These records must be safeguarded and maintained.

3.8 Review materiel and other Test Reports for compliance with the relevant code, standard or specification.

3.9 Submit the following items to the Licensee for approval:

• 3.9.1 Any proposed deviation from the chosen Technical Specification including design code;
• 3.9.2 Any proposed concessions, for example to use materials which do not comply in full with the chemical and mechanical properties of the materials defined in the Technical Specification or applicable Design Code;
• 3.9.3 Any other proposed deviation from the technical requirements of the Technical Specification or agreed QA arrangements

4 Inspection Agency

Figures 1 and 2 illustrate the relationship between the Inspection Agency and other parties for both independent (third party, Type A) and non-independent (second party, Type B) scenarios.

An inspection department maintained by the manufacturer does not satisfy the requirement of an IA, except for limited, specific responsibilities delegated at the discretion of the IA as defined above.

In the UK, accreditation meeting the requirements of ISO 17020 implies the Inspection Agency is accredited through the UK Accreditation Service (UKAS) or another recognised Accreditation Body that is a signatory to an appropriate international multi-lateral agreement for mutual recognition.

The responsibilities of the Inspection Agency are to:

4.1 Maintain access to Surveyors who are suitably trained and qualified to perform the duties required, including familiarisation with the requirements of the design code.

4.2 Assess and monitor the Quality Assurance Programme activities of the Contractor, its Sub-Contractors and suppliers. This responsibility will generally be carried out in participation with the Licensee and/or its Contractor, but may be supplemented by independent monitoring as necessary.

4.3 Verify that all materials used comply with the applicable requirements by witnessing examinations or carrying out inspection as it considers necessary. Such inspections shall include verification of methods of identification and traceability of materials, items and components.

4.4 Witness or verify in-process fabrication and erection, non-destructive examination and tests as necessary, and witness final pressure tests. Such verification shall include the review of welder qualification and welding procedure qualification records, the endorsement of witnessed test results, and the review of non-destructive examination personnel qualification records.

4.5 Endorse Certification Forms and other documents requiring Inspection Agency certification.

4.6 Review and comment on drawings and process procedures, designate hold and notification points on Quality Plans and inspect against them.

5 Accredited organisation that issues the Licensee's Certificate

The responsibilities of the organisation that issues the Licensee's Certificate are to:

5.1 Verify that the Licensee understands its Quality Assurance responsibilities specifically with regard to items or services significant to nuclear safety.

5.2 Verify the Licensee's agreement to meet the requirements of its responsibilities.

5.3 Check the Licensee's Quality Assurance Programme is sufficient to discharge the Licensee's responsibilities.

6 Framework of Certification Forms

The following are examples of Certification Forms for nuclear safety related pressure equipment and the organisations expected to certify them.

Type of Form	Certifying Organisations
General
Technical Specification Certification	Licensee (or designee*) , IA
Design Report Certification 1	Contractor or designer, IA
Design Report Certification 2 (As- Installed/Final Design Report)	Licensee (or designee*), IA
Specific
Contractors' Certification Form for Vessels	Shop fabricator, Site installer, IA
Contractors' Certification Form for Pipework System Installation and Compliance with system Requirements	Shop fabricator, Site installer, IA
Certification Form for Piping Sub-Assemblies	Shop fabricator, Site fabricator, IA
Certification Form for Pumps and Valves	Manufacturer, IA
Certification Form for Safety and Safety Relief valves	Manufacturer, IA
Certification Form for Core Support Structures	Manufacturer, IA
Certification Form for Component Supports	Shop fabricator, Site installer, IA
Licensee's Certification Form for Completed Installation	Licensee, IA

* Delegated by the Licensee.

Each form is expected to be short, typically one or two pages, and it should adequately identify the components(s) and system(s) covered. Supporting, lower tier forms, should be attached as necessary.

Figure 1. Organisational arrangements where full inspection independence from the purchaser or licensee is required

Note:

Where the Licensee's organisation is not in place or is not yet fully developed, some or all of the Licensee's responsibilities may be undertaken by the purchaser.

Figure 2. Organisational arrangements where full inspection independence from the purchaser or licensee is not required

Note:

Where the Licensee's organisation is not in place or is not yet fully developed, some or all of the Licensee’s responsibilities may be undertaken by the purchaser.

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