Contract Quality Requirements Manual

Transcription

1 SLM Issue 4 Effective date: 09/2017 Contract Quality Requirements Manual Page 1

2 SLM Issue 4 Effective date: 09/2017 Page 2 Contents Introduction... 4 Aims... 4 Purpose and Scope... 4 Projects, Products and Services... 5 Flow - Down... 6 Terminology... 6 Symbols Used in this Document... 6 Relevant Legislation / Regulation... 7 Guiding Principles / Concepts... 7 Commitment to Working Together... 7 Contract Quality Requirements... 9 Introduction... 9 Contractor Request for Deviation from Contract Quality Arrangements Nuclear Safety Requirements Pre-Contract Phase Quality Management System Arrangements Software (including Programmable Electronic Systems PES) Contract Placement Phase Resource Management Modern Slavery Act (MSA) Procurement A Graded Approach to Procurement Grading Procurement Information Contractor / Sub-Contractor Selection Review of Contract Requirements Sub-Contractor Control Assurance... 19

3 SLM Issue 4 Effective date: 09/2017 Page 3 Sellafield Ltd Oversight Internal Oversight Contractor Oversight Performance Measurement Design Control of Design Design Review Requirements Design Output, Review, Checking and Approval Product and Service Realisation Quality Plans Management of Counterfeit, Fraudulent and Suspect Items or Services (CFSI) Foreign Material Exclusion (FME) Product Traceability Material Certification Verification and Inspection of Products and Services by Sellafield Ltd Control of Measurement and Test Equipment Deviation and Non-conforming Product or Process Acceptance and Release Certificate of Conformance Release of Goods Release of Goods on Sellafield site Records Delivery and Receipt Preservation of Product Appendix A Typical Oversight & Assurance Activities Appendix B Related References Appendix C Glossary... 36

4 SLM Issue 4 Effective date: 09/2017 Page 4 Introduction Sellafield Ltd operates as an Intelligent Customer and as such applies the appropriate level of oversight of Quality Management System arrangements regarding Projects, Products and Services with particular focus on Nuclear Safety. This document describes the levels of oversight and assurance activities that existing Contractors / Sub-Contractors and potential new entrants will be required to adhere to as part of the Sellafield Ltd. Supply Chain. It outlines the expectations regarding the interactions between the Customer and the Contractor in the context of the oversight of quality assurance activities, for which a detailed, but not exhaustive list can be found in Appendix A: Typical Oversight & Assurance Activities. Sellafield Ltd and regulators, such as the Office for Nuclear Regulation (ONR), reserve the right to undertake oversight of the Contractor s management system arrangements and all work being delivered within the Contract scope including sub-contracted work. Oversight may be by means of assessment, inspection, verification, surveillance or formal audit. The Contractor shall ensure that its Sub-Contractors are informed of this requirement. Aims This document aims to ensure the safe, predictable and reliable delivery of Projects, Products and Services through quality control, assurance, verification and validation activities. It extends to all tiers of the Supply Chain via standard flow-down arrangements. Flow-down is the distribution of the Customer s quality arrangements established for the specified Quality Grade or Specification. These arrangements shall also be adopted regardless of where the Contractors are geographically located and operating. Purpose and Scope The oversight arrangements, Contract Quality Requirements and performance metrics detailed in this document reflect principles and activities that promote Quality Control, assurance, verification and validation of Projects, Products and Services within the Sellafield Ltd Supply Chain. These oversight and assurance arrangements are designed to minimise the risk of non-conformance, defects and Counterfeit, Fraudulent and Suspect Items (CFSI), whilst ensuring the provenance of materials. This may include, but is not limited to the following: identifying and managing risks within the Supply Chain principles for establishing levels of Contractor oversight. principles for the adjustment of oversight to address levels of risk qualification of Suitably Qualified and Experienced Persons (SQEP) sharing of information across the industry relating to Contractor risk

5 SLM Issue 4 Effective date: 09/2017 Page 5 Projects, Products and Services This document encompasses all phases of Contract delivery by the Sellafield Ltd Supply Chain as shown below and Appendix A: Typical Oversight and Assurance activities Pre-Contract Contract Placement Product and Service Realisation Design Acceptance and Release Delivery and Receipt Commissioning Installation It covers oversight and assurance arrangements for all Projects, Products and Services supplied to Sellafield Ltd and as determined by the gradation of risk and safety classification or categorisation, including installation and commissioning activities.

6 SLM Issue 4 Effective date: 09/2017 Page 6 Flow - Down The Contractor shall comply with all the requirements as applicable to the specified Quality Grade defined in this document and ensure the requirements are flowed to every applicable tier of the Supply Chain where the risk associated with the procurement of the goods or services continues to be Quality Grade QG01, QG02 or QG03. If the product or service being procured carries low/no risk it can therefore be classified as a Quality Grade QG04; in these instances the flow-down of the Sellafield Ltd Contract Quality Requirements is no longer required as there are no applicable requirements for a QG04 product or service and Industry best practice for managing and delivering the product or service should be applied. Customer (SL) The Supply Chain is governed by the contractual obligations which are in place between the different tiers of the Supply Chain. Sub Supplier (Tier 2) Sub Supplier (Tier 3) The Customers oversight and assurance requirements cascade down the Supply Chain through contractual requirements Sub Supplier (Tier 4) Terminology A full glossary of terms used is available at the back of this document Appendix C Symbols Used in this Document The requirements of each Quality Grade are identified using the key shown to the right of each heading or sub heading. Where the key is coloured green all the clauses within the heading or sub heading shall apply. The example to the right indicates that all clauses are applicable to Quality Grade QG01, Quality Grade QG02 and Quality Grade QG03. Where the Quality Grade disc is shown as pale green, the requirement is by exception / agreement e.g. Quality Grade QG03 - Quality Plans may be required to be submitted to Sellafield Ltd and will require surveillances / reviews by SL SQEP as described in Section 5: Quality Plans Quality Grade Quality Grade 1 2 3

7 SLM Issue 4 Effective date: 09/2017 Page 7 Relevant Legislation / Regulation This document has been generated with consideration of relevant health and safety legislation. Where appropriate legislation has been referenced, however, the primary legislation that has influenced this document is: Office for Nuclear Regulation Licence Condition Handbook Office for Nuclear Regulation Technical Assessment Guide (TAG 077) International Atomic Energy Agency - Safety Standards Guiding Principles / Concepts The following principles underpin the successful application of oversight and assurance of Quality Management system arrangements within the Sellafield Ltd Supply Chain, and Customers and Contractors shall act in accordance with these principles at all times: Sellafield Ltd will act as the Intelligent Customer Contractors shall satisfy customer requirements at all times Contractors shall support Nuclear Safety requirements at all times Contractors shall understand and apply the principles of configuration management where appropriate Contractors shall understand and operate robust change control processes Contractors shall promote cultures and behaviours that support the principles of the nuclear industry Sellafield Ltd and the Supply Chain will be transparent and share information, including lessons learnt from Operational Experience (OE) and discovery of CFSI Commitment to Working Together Sellafield Ltd is committed to working together with its Supply Chain delivering excellence in everything it does; having the right people, with the right skills in place at the right time. This requires the Customer and its Supply Chain to develop a supporting relationship, working together to deliver to the required standards, identifying opportunities to improve performance, preventing concerns escalating and resolving issues promptly through, Open and Honest Communication At all levels and tiers, throughout the Supply Chain raising queries and concerns as they become known Checking for understanding and compliance at all levels and tiers of the Supply Chain ensuring that specifications, requirements, and identified processes are flowed down, understood, and met. Sharing Learning Identifying and building on best practice Utilising Learning From Experience (LFE) to prevent issues and improve performance

8 SLM Issue 4 Effective date: 09/2017 Page 8 Focused Improvement Having the right measures, Using the right tools, Looking at the right things Structured Problem Solving Basing decisions on data Addressing the root cause Implementing robust corrective actions

9 SLM Issue 4 Effective date: 09/2017 Page 9 Contract Quality Requirements Introduction Nuclear quality standards aim to support the delivery of excellence in all aspects of services, operating safely, securely, reliably and predictably. To achieve this aim, it is a requirement for the Supply Chain to deliver the quality of Projects, Products and Services safely, to schedule, to the specified requirements and to the agreed cost. The purpose of this section is to define the Contract Quality Requirements that will enable the delivery of Projects, Products and Services to the Sellafield Ltd Quality Grades (very high risk, high risk, medium risk and low/minimal risk). This document emphasises the elements over and above those in the latest edition of BS EN ISO 9001 that are key to successful delivery of Projects, Products and Services to the Sellafield Ltd Supply Chain requirements. Contractor Request for Deviation from Contract Quality Arrangements If the Contractor is unable to comply with any of the requirements applicable to the Quality Grades defined within this document, the Contractor shall complete form SLF to request agreement from the customer that it is acceptable to deviate from the contracted requirements. A copy of the completed form should be retained within the Life Time Record (LTR).

10 SLM Issue 4 Effective date: 09/2017 Page 10 1 Nuclear Safety Requirements According to IAEA SF-1, Nuclear Safety means the protection of people and the environment against radiation risks and the safety of facilities and activities that give rise to the radiation risks. In order to achieve this aim, Sellafield Ltd needs its Supply Chain to deliver goods and services to the agreed specified requirements. A key focus for Sellafield Ltd is ensuring that all Supply Chain personnel involved in design, manufacturing, fabrication, construction, inspection and testing understand how their role impacts upon Nuclear Safety and how the failure of a product or service can impact upon the associated plant and potentially have wider consequences. The design intent needs to be translated into the construction phase and must be realised in the quality of the Contractor s workmanship. This involves ensuring that the manufacturing, fabrication and construction Contractors understand how the quality of their workmanship can impact on Nuclear Safety. Other factors which may affect Nuclear Safety Requirements also need to be considered, including aspects such as understanding the constraints of construction site work, proximity to Nuclear Buildings, restrictions on cranes deployment, vibrating machinery, etc. There are 8 internationally accepted principles of a strong Nuclear Safety Culture: Everyone is personally responsible for nuclear safety. Leaders demonstrate commitment to safety. Trust permeates the organisation. Decision-making reflects safety first. Nuclear technology is recognised as special and unique. A questioning attitude is cultivated. Organisational learning is embraced. Nuclear Safety undergoes constant examination. 1.1 The Contractor shall establish and promote an effective Nuclear Safety Culture defined within its own organisation and that of its Supply Chain by: Ensuring a common understanding of the key aspects of Nuclear Safety within the organisation. Providing the means by which the Contractor is able to develop a Nuclear Safety Culture Reinforcement of a learning and questioning attitude at all levels of the organisation regarding Nuclear Safety. The Contractor shall ensure that all personnel involved in the provision of work for Sellafield Ltd understand any Nuclear Safety implications of failure of the product or service to meet the specified design intent.

11 SLM Issue 4 Effective date: 09/2017 Page 11 The Contractor shall ensure that personnel are aware of the implications of Suspect and Counterfeit products being deployed on the Sellafield site. Refer to SLSP : Nuclear Safety for the Suppliers of Goods and Services to Sellafield Ltd for guidance on this subject. Finally, the transition from manufacturing, fabrication, construction, through commissioning to operations needs to be appropriately managed in order to ensure the necessary knowledge is passed over to the requisite personnel.

12 SLM Issue 4 Effective date: 09/2017 Page 12 2 Pre-Contract Phase Quality Management System Arrangements Quality Grade All Contractors shall maintain a Quality Management System that is compliant to the latest edition of BS EN ISO 9001 or equivalent, and which has been certified by a United Kingdom Accreditation Service (UKAS), accredited Certification body or internationally accepted equivalent, as defined by the International Accreditation Forum (IAF). 2.2 The Contractor shall monitor, review and update its Quality Management System as necessary to comply with Good Industry Practice and to ensure continued certification. 2.3 Prior to contract award the Contractor shall demonstrate their capability to deliver Projects, Products and Services in accordance with the Customer s requirements. 2.4 In the event that the Contractor s Quality Management System is made up of a multiple number of certified Quality Management Systems (alliance/ collaborative partnerships), the Contractors - shall make their operational Quality Management System arrangements and the Alliance / partnership Quality Plan available to the Customer within the agreed timeframes. 2.5 The Contractor shall appoint a suitably qualified and experienced Quality Management representative, supported by competent experienced personnel, to ensure effective implementation of the Quality Management System arrangements. 2.6 Upon request, the Contractor shall provide Sellafield Ltd with copies of management review records relevant to the Contract work scope. 2.7 The Contractor shall notify Sellafield Ltd of any management review actions which will affect compliance with contractual requirements. 2.8 Management review output shall identify responsible persons and due dates for completion of agreed action. 2.9 Where proposed changes to the Contractors Quality Management System could have the potential to impact upon product quality or affect (lead to the loss of) the Contractors certification, those changes shall be submitted, by the Contractor, to Sellafield Ltd for acceptance / approval. Sellafield Ltd may only withhold its consent to such a change if, in its reasonable opinion, the proposed change does not comply with: internationally accepted Quality Management Systems or Good Industry Practice at the time of the request; or any other obligations in relation to Quality Management Systems placed on the Contractor under the Contract.

13 SLM Issue 4 Effective date: 09/2017 Page When responding to any Contractor request for Sellafield Ltd acceptance / approval of changes to the Contractor s Quality Management Systems, Sellafield Ltd shall respond in writing; and provide any reasons for determining that the Contractor s proposed changes to its Quality Management Systems are unsuitable The Contractor shall provide evidence of compliance to the Contract Quality Requirements to Sellafield Ltd upon request e.g. gap analysis or compliance matrix The Contractor s management arrangements shall address all statutory and regulatory requirements appropriate to the Contract scope. The Contractor shall identify and have access to these requirements, determine how they apply, and implement them when providing product(s) or service(s) The Contractor shall ensure that all personnel executing the contracted scope of work are aware of and understand the management system arrangements. This includes any amendments relevant to the scope of work The Contractor shall ensure that documentation requiring submittal to Sellafield Ltd for information or for review and acceptance, shall be submitted as detailed in the Contract and Sellafield Ltd Contract Quality Requirements The Contractor s procedure for controlling documents between Sub-Contractors and the Customer shall ensure documents are clearly identifiable to each Sub- Contractor. Version control of documents between the Contractor, Sub-Contractor and the Customer shall be appropriately managed The Contractor shall have a Business Continuity process in place that identifies potential threats to the organisation and the impacts to business operations those threats, if realised, might cause. The Contractor shall have in place an effective response that safeguards the interests of its key stakeholders, reputation, brand and value-creating activities. These should include but not be limited to: Adverse Weather (snow/ice, floods) Fuel Crisis/Loss of utilities Loss of key personnel (sickness or other) Loss of premises (fire, flood etc.) Loss of Systems (IT/Communications/information)/Cyber attack Loss/disruption to the Supply Chain Others applicable to the business.

14 SLM Issue 4 Effective date: 09/2017 Page 14 The Contractor should consider: Potential impact of relevant threats of the above instances Alignment or accreditation to BS EN ISO 22301:2014 (Societal security - Business Continuity Management Systems - Requirements ) Responsibility for arrangements Visibility of arrangements Testing/Exercising. Review/Improvements to the Plan 2.17 The Contractor shall have a documented process for Learning from Experience to demonstrate improvement, and be able to show effective implementation 2.18 In addition to the Contract Quality Requirements, Contractors engaged on Sellafield Ltd Projects shall follow SLSP : Quality Standards for SL Projects and Contractors engaged on SL Projects, and its subsets as stated in the Contract. Software (including Programmable Electronic Systems PES) 2.19 As a minimum, where the Contract includes design, Quality Grade development, supply and installation, modification or maintenance of software, then the current revisions of BS ISO/IEC 90003: Software Engineering Guidelines for the Application of BS EN ISO 9001:2015 to Computer Software is applicable together with BS ISO/IEC 12207: Systems and Software Engineering Software Life Cycle Processes Where the Contract includes the design, development, supply or installation of a PES the Contractor shall comply with the requirements of ES_1_2479_1: Programmable Electronic System Based Instrumentation and Control Where the Contract includes the design, development, Quality Grade supply or installation of a PES that forms part of a safety system, the Contractor shall additionally comply with the requirements of ES_1_2190 Parts 1 4: The Engineering standard for Electrical, Electronic and Programmable Electronic (E/E/ PE) Safety Measures Where the Contract includes work on a PES that forms all or part of a safety system, the Contractor shall demonstrate that they operate functional safety management arrangements that align with the principles set out in the latest revision of BS EN (all appropriate parts) Functional Safety of Electrical/ Electronic/ Programmable Electronic Safety Related Systems.

15 SLM Issue 4 Effective date: 09/2017 Page 15 3 Contract Placement Phase Resource Management Modern Slavery Act (MSA) 2015 Quality Grade Contractors shall implement Supplier Code of Conduct (and potentially due diligence questionnaires) with specific focus on modern slavery issues including Contractor control, oversight, and assurance mechanisms 3.1 The Contractor shall implement an induction course to include the full scope of works. The Contractor shall ensure that all personnel deployed on the works receive the induction course prior to commencing work on the Contract. The induction course shall as a minimum include: Nuclear Safety Conventional Safety requirements Security requirements Overview of the works Mandatory procedures Standards and Specifications requirements briefs Effective oversight utilises SQEP. To be considered SQEP, individuals professional competence shall be demonstrated and traceable to a competency matrix linked to their role. Professional competence is deemed to be demonstrable knowledge, skills and experience as appropriate to the task or activity being undertaken, and shall be supported by formal training and qualification(s) (national / international). Evidence of scheduled Periodic Reviews shall be maintained and Forward Planning to close out identified competency requirements. 3.3 The Contractor shall notify Sellafield Ltd of any deficiencies identified with personnel competency that may affect the product or service provided. The Contractor shall take corrective actions to eliminate personnel competency deficiencies. 3.4 The Contractor shall define and implement appropriate arrangements to control any change to its organisational structure or resources which may affect environmental, health and safety, security and quality performance. Any such changes shall be formally notified to Sellafield Ltd. 3.5 The Contractor shall be able to demonstrate the qualification and independence of Personnel verifying or inspecting work from those performing the work. 3.6 All Inspection and test Quality Control plus special processes (Welding, NDE, Heat treatment, Painting & Coating etc.) personnel deployed on the works are suitably experienced and shall be in possession of nationally recognised and current qualifications in mechanical and electrical disciplines. 3.7 All testing and inspection practitioners shall be experienced in the application of the technique to the specific material.

16 SLM Issue 4 Effective date: 09/2017 Page 16 Procurement A Graded Approach to Procurement Quality Grade Sellafield Ltd implements a graded approach to the procurement of goods and services within the Supply Chain (SLP : How do I determine the Quality Grade of my Supply Chain Requirements ). This graded approach ensures that the appropriate levels of oversight and assurance are deployed, commensurate with the level of risk. For Projects, SLSP : Application of Assurance & Oversight for Project Plant & Equipment is applicable. The Contractor shall also apply a graded approach to procurement, deploying resources on consideration of: The magnitude of potential consequences if a product fails or an activity is carried out incorrectly The significance and complexity of each product or activity The hazards and the magnitude of the potential impact (risks) associated with the safety, health, environmental, security, quality and economic elements of each product or activity. Contractors supplying Projects, Products or Services to Sellafield Ltd and requiring further information on Sellafield Ltd s graded approach to procurement shall refer to Sellafield Ltd Practice SLP The Quality Grades QG01 and, QG02 will require Sellafield Ltd oversight and assurance activities at the Contractor s works or locations of the activity and shall require submission of Quality Plans, Inspection and Test plans or method statements to the specification requirements. Special Process procedures shall require submission regardless of Quality Grade. Quality Grade QG03 for medium risk products and services require receipt inspection by Sellafield Ltd inspectors. Subject to agreement with Sellafield Ltd a Quality Plan may be required to be submitted to Sellafield Ltd and will require surveillances / reviews by SL SQEP as described in Section 5: Quality Plans. Sellafield Ltd utilises one additional Quality Grade code that may be applicable for the direct supply of product to Sellafield Ltd. Quality Grade QG 02P (Proprietary) - Utilised for the procurement of proprietary spares and equipment (i.e. typically catalogue items) for Sellafield Ltd sites from a source of proven capability. The procurement risk assessment may identify a high risk; however the Contractor shall be compliant with Quality Grade QG03 requirements for this code. If the product or service being procured can be demonstrated to carry low/no risk, then a Quality Grade QG04 may be applied. Where a number of items make up an overall assembly the risk of failure of each component of the final assembled item must be considered independently and therefore graded accordingly in line with SLP

17 SLM Issue 4 Effective date: 09/2017 Page 17 However, attention is drawn to the table in the SLP with respect to Risk Mitigation Measures which states that a Quality Grade QG04 should: Only to be used for items that, if failed on delivery or utilisation would have Low to No implications with regard to Nuclear/ Radiological safety, Conventional safety, Environmental impact, Business risk. Grading 3.8 The Contractor shall implement a graded approach in accordance to SLP for the procurement of products and services to mitigate the risk of failure. For additional detail please see above A Graded Approach to Procurement. Procurement Information 3.9 The Contractor shall ensure that the requirements of the Contract, the Sellafield Ltd Contract Quality Requirements, the appropriate standards / specifications, and necessary requirements to deliver the Projects, Products and Services specified, are flowed-down to, and understood by, all tiers of the Contractor s Supply Chain The Contractor shall ensure the purchasing information accurately specifies the requirements for acceptance of Projects, Products and Services, to include as applicable: Reference to these CQRs Quality Grade Specification(s) and works information Drawing(s) Material Type Quantity Certification requirements Inspection requirements, at vendor, on delivery or both Functional testing requirements, at vendor, on delivery or both Any special requirements such as packing, extra testing etc Requirements for procured services 3.11 If required, and where agreed at the Contract Opening Up meeting, copies of purchase information raised by the Contractor which is equivalent to Quality Grade QG01/02 should be sent to ICG@sellafieldsites.com. Contractor / Sub-Contractor Selection 3.12 The Contractor shall have a process for sub-contractor selection through robust and auditable assessment and analysis of their competencies, facilities and equipment to ensure that they have the capability to conform to the Contract requirements, delivering products and service safely, to schedule, of the correct quality and to the agreed cost Instruction from Sellafield Ltd to use a specific sub-contractor does not absolve the Contractor from completing an evaluation of the sub-contractor s capabilities to meet the requirements and commitments of the Contract. Adverse results must be communicated to Sellafield Ltd for discussion.

18 SLM Issue 4 Effective date: 09/2017 Page The Contractor shall assess the sub-contractor s capability to plan and meet the required capacities beyond existing or new Contracts The Contractor shall ensure that any weaknesses / risks identified during tender assessment are managed post Contract award by discussion / agreement at the Opening Up meeting. Review of Contract Requirements 3.16 The Contractor shall be able to demonstrate that their Contract review process includes the following: All Contract requirements for the scope of work are reviewed, agreed and understood Understanding of works information packages Review of Purchase Order information (estimating/purchasing) Opening up meetings with sub-contractors to ensure full understanding of the Contract requirements Ongoing Contract review 3.17 Where the contract includes the following elements, the review shall as a minimum include the following:- Project/Contract Management Commercial Health and Safety Quality (including Nuclear Safety and Specification Awareness Briefs) Project Controls (planning, programme and costs) Risk Engineering Construction Inspection and Testing Commissioning Operations and Maintenance Provision of product samples (when requested) Life Time Records (LTRs) 3.18 Records of the ongoing reviews and the conclusion reached shall be retained and form part of the LTR. Sub-Contractor Control 3.19 The Contractor shall ensure that the full extent of their Supply Chain has a clear understanding of the Sellafield Ltd Contract Quality requirements and the standards / specifications selected 3.20 If the Contractor sub-contracts work, the Contractor is responsible for controlling the scope of work in accordance with the specified requirements

19 SLM Issue 4 Effective date: 09/2017 Page The SL Tier 2 Contractor shall produce a diagram that shows the totality (inclusive of materials, components, sub-assemblies, assemblies and plant items) of the Supply Chain delivering the contracted scope of work. The diagram shall take the form of an organisation chart, colour coded in accordance with SLF or equivalent to identify the type and level of assurance to be applied by the Contractor to each sub-contract. The diagram shall specifically include: Organisational hierarchy between contracting parties Names of contracting parties Quality assurance arrangements (audit, surveillance, inspection and test) that shall be applied to each sub-contractor. Quality Grade of the sub-contracted work The Contractor shall submit the diagram to the Customer with the tender for acceptance. The diagram shall be maintained and visible throughout the lifetime of the contract The Contractor supplying products or services directly to Sellafield Ltd shall, in accordance with the Contract, provide for acceptance a schedule of intended sub- Contractors, using Sellafield Ltd form CFMT 121 Main Contractors identification and proposed control of sub-contractor and Suppliers available from Sellafield Ltd Commercial Department. The Contractor shall only sub-contract work in accordance with the agreed schedule submitted with the tender or in accordance with agreed changes following submission of a revised schedule The Contractor shall provide to the Customer details and justifications of any proposed increase or reduction in the control over its sub-contractors or replacement of any sub-contractors. Assurance Sellafield Ltd Oversight 3.24 Sellafield Ltd reserves the right to undertake oversight of the Contractor s management system arrangements and all work being delivered within the Contract scope including sub-contracted work. Oversight may be through qualification, inspection, verification, surveillance, assessment and formal audit. The Contractor shall ensure that its sub-contractors are informed of this requirement.

20 SLM Issue 4 Effective date: 09/2017 Page 20 Internal Oversight 3.25 The organisation shall have an Internal Assessment programme that focuses upon Product Quality related processes as applicable including but not limited to: SQEP Weld Procedures and Qualifications NDE Procedures and Qualifications Material Segregation and Workface cleanliness Load and pressure test procedures Calibration LTR compilation Sub Contract Management Quality Planning Painting and Coating procedures Testing Procedures including FAT Contractor Oversight 3.26 The Contractor shall document and establish sub-contractor assurance and oversight arrangements to ensure compliance with the Sellafield Ltd specifications, standards and Contract Quality Requirements. These arrangements shall be aligned to the graded approach and be tailored to mitigate risk to Nuclear Safety. This shall cover the scope of work to be undertaken by the Contractor during each financial year. Evidence of this shall include: Implemented assessment schedule based on risk (QG 01, 02 or 03) Supplier assessment reports Inspection reports The use of Quality Plans/ITP s Surveillance reports Upon request, the Contractor shall report progress against their assurance programme to Sellafield Ltd. including any deficiencies identified affecting compliance with Contract Quality Requirements The Contractor shall be able to demonstrate the health of their key Supply Chain by means of ongoing monitoring. Evidence of this shall include but not be limited to, the following: Goods Inward non-conformance reporting process Inspection results Surveillance reports (Expediting) Product quality related issues Delivery to schedule CFSI Issues

21 SLM Issue 4 Effective date: 09/2017 Page 21 The Contractor shall report to Sellafield Ltd deficiencies identified from their assurance programme that will affect compliance with contractual requirements. Corrective actions shall identify remedial measures and preventive actions to avoid recurrence. Performance Measurement 3.28 The Contractor shall in accordance with the Contract requirements establish and agree a set of metrics to enable measurement of performance against contracted and subcontracted work scopes. The metrics shall as a minimum measure the Contractor s safety, schedule, quality and cost performance The Contractor shall ensure Specific, Measurable, Achievable, Realistic and Time bound (SMART) action is taken if sub-contractor performance is not achieving the required standard or upon the identification of a deteriorating and/or adverse trends.

22 SLM Issue 4 Effective date: 09/2017 Page 22 4 Design Quality Grade Control of Design 4.1 The Contractor shall ensure that all design interfaces are clearly defined and controlled. 4.2 The Contractor shall ensure that roles and responsibilities of appropriate design disciplines, for example, mechanical, electrical, process, safety and civil, are clearly understood and communicated to ensure their involvement at the appropriate stages. 4.3 The Contractor shall ensure that all designs and document changes issued to the customer are controlled by the documented management system process. Design changes shall be conducted at the same level as the original design review and verified accordingly. 4.4 The Contractor shall ensure that IT software used in analysis and computation of high risk activities is acceptance tested, validated, has a test plan, and is not used beyond its life cycle without appropriate validation. Design Review Requirements 4.5 When the design responsibility lies with the Contractor as defined within the Contract, the Contractor shall identify and implement their proposed design reviews on a Quality Plan that shall be accepted by the Customer prior to the commencement of work. 4.6 Third party design verification activities shall be documented and included within a Quality Plan to ensure that responsibilities and communication interfaces are clearly defined. 4.7 The Contractor shall submit all documents, to be considered at design review, to the Customer in a fully approved state at the agreed timescale prior to the design review. 4.8 Sellafield Ltd reserves the right to participate in Contractor design reviews. 4.9 Sellafield Ltd reserves the right to identify any design activity which requires confirmation or third party verification The Contractor shall document the results of all design reviews and transmit the results to the Customer. Actions resulting from design reviews shall be completed before final Customer approval of the design Verification reviews of design calculations and analyses performed by alternative means shall be controlled to determine when, by what method and by whom the calculations were performed, and be traceable back to the original design.

23 SLM Issue 4 Effective date: 09/2017 Page 23 Design Output, Review, Checking and Approval 4.12 Review, checking and approval of design outputs shall be undertaken by suitably qualified and experienced personnel independent of those having direct responsibility for the work being performed Design Output, whether in electronic or paper form, shall be considered as Life Time Records and delivered in accordance with Section 6.6: Records

24 SLM Issue 4 Effective date: 09/2017 Page 24 5 Product and Service Realisation Quality Plans 5.1 Where a Quality Plan / Manufacture, Inspection and Test Plan (MITP) or Method Statement is required by the Quality Grade Technical Specification or the Quality Grade, the Contractor shall agree the content with the Customer at the Opening Up / Initial Meeting. From this point on in this document, these will be known as Quality Plan(s). Refer to SLSP and associated forms. 5.2 The distribution for review and approval of Quality Plans and / or Manufacture, Inspection and Test Plans shall be agreed at the Opening Up/Initial meeting for the Contract, Project, task specific Purchase Orders or operations. 5.3 Where the work covers a number of phases for example design, manufacture, construction, installation and commissioning, separate Quality Plans shall be prepared, submitted and identified on a Sellafield Ltd Supply Chain Model / sub- Contractor map SLF (In these instances a top level over-arching Quality Plan should be prepared for the identified scope which references each individual sub-quality Plan and/or Manufacture, Inspection and Test Plan where applicable. Benefits of this approach allow for Quality Plans to be produced concurrent with the phase of work and allow for closure when complete). 5.4 The Contractor shall submit the Quality Plan(s) and Manufacture, Inspection and Test Plans to the Customer for acceptance within the timeframe agreed with the Customer. 5.5 The Contractor shall not commence work identified in the Quality Plan and Manufacture, Inspection and Test Plans prior to confirmation of acceptance by the Customer 5.6 The Contractor shall document within Quality Plans, the controls to be applied to its sub-contractors. Any change to an approved/accepted quality or Inspection and Test Plan shall be resubmitted to the Customer for approval and/or acceptance. 5.7 Special processes within the specification shall be identified within the Quality Plan and Inspection and Test Plans. Regardless of Quality Grade, these activities will require submission and approval/acceptance by Sellafield Ltd. Typical special processes include but are not limited to welding, pipe work bending, heat treatment, non-destructive testing, material finishes and concrete mix design. 5.8 For Projects, Products and Services, the Quality Plan and /or Inspection and Test Plans shall conform to the following Sellafield Ltd criteria: The Quality Plan and/or Manufacture, Inspection and Test Plans shall be prepared listing the activities necessary to demonstrate compliance with the specified requirements and to discharge the work. The activities shall be listed in a logical sequence and be broken down into a level of detail required to discharge the work, for example, phases associated with the Contract lifecycle and different packages of work.

25 SLM Issue 4 Effective date: 09/2017 Page The Quality Plan and/or Manufacture, Inspection and Test Plans shall identify against activities all applicable procedures, standards and specifications, controlling arrangements, accountability for delivery and associated records. The wording and output of the activity shall be clear, concise and unambiguous The Quality Plan and Inspection and/or Test Plans shall identify the agreed minimum records to be included in the LTRs. These records shall be reviewed, approved and accepted in accordance with the specification and contract requirements Sellafield Ltd reserves the right to identify hold/witness points in the Quality Plan and/or Inspection and Test Plans. The Sellafield Ltd representative may identify hold points in the Quality Plan beyond which work must not proceed without Sellafield Ltd verification and/or permission. If work commences prior to Sellafield Ltd. s acceptance of the Quality Plan, or work progresses past a hold point without the required sign off on the Quality Plan, Sellafield Ltd shall raise a non-conformance requiring corrective and preventive action To monitor the work, the Quality Plan and Inspection and Test Plans shall facilitate the signing off of all activities against the agreed Inspection Activity Codes identified in the approved Quality Plan. The selection of an activity code shall take into account the specification, novelty or difficulty of the activity and the criticality of the result. Quality Plans and Inspection and Test Plans shall be kept up to date to reflect current status that is, signatures/dates recorded etc. The following activity codes shall be used to identify the action required: Action Activity Code 100% inspection A1 Sample inspection A2(#) 100% witness W1 Sample witness W2(#) 100% review R1 Sample Review Hold point Approval Surveillance R2(#) (#) Where sample is identified, the percentage (%) shall be defined with the code for example, R2 (10) = 10% sample review. H AP S

26 SLM Issue 4 Effective date: 09/2017 Page The Quality Plan and/or Inspection and Test Plans shall consist of three main parts: Cover sheet, Documentation Sheet and Activity Sheet. The cover sheet shall identify the following: Company name Title Reference numbers (Sellafield Ltd Contract number, Contractor reference number and sub-contractor reference number if applicable) Plant item number or material master number Scope of work the Quality Plan covers Activity codes and description SQEP nominated roles, including signatory list, for signing off the Quality Plan activities Quality Plan acceptance (names, signatures and dates) Final sign off when the Quality Plan is complete The Documentation Sheet shall identify all standards and specifications applicable to the scope of work The Activity Sheets shall identify activities and activity codes, documents, nominated roles and records required to be generated to be included in the LTRs When completed the Quality Plan and Inspection and Test Plans should be able to act as a route map from the original scope of work, to the underpinning LTRs The contractor shall establish a measure which demonstrates the current concurrency of key controlling documents e.g. Quality Plans, ITPS, and be able to report at the agreed timescale. Management of Counterfeit, Fraudulent and Suspect Items or Services (CFSI) 5.9 The Contractor shall ensure that processes are in place to mitigate the risk of CFSI being deployed to Sellafield Ltd. The processes shall include identification of CFSI, assurance of product and service source, selection of sub-contractors and other Suppliers and verification that purchased products or services meet the specified requirements In the event of CFSI being found the Contractor shall immediately quarantine the item, notify Sellafield Ltd in case a similar item is in use, and initiate the nonconformity process as described in Deviation, Non-conforming Product or Process (Clause ). Such product shall not be returned to the Supplier to prevent their re-introduction into the Supply Chain. The information should be treated as LFE and disseminated to Sellafield Ltd The Contractor shall ensure that processes are in place to control and document the disposition of items identified as Suspect. Sellafield Ltd shall be provided records of the dispositions of Suspect Items, as agreed at the opening up meeting. Quality Grade 1 2 3

27 SLM Issue 4 Effective date: 09/2017 Page 27 Foreign Material Exclusion (FME) 5.12 The Contractor shall have a FME process. The process should include but is not limited to the following: Quality Grade identification as to whether FME principles apply to the scope of work and if so, when, i.e. final vessel closures, works testing, dismantling, packing and dispatch identification, segregation and management of FME areas identification and use of materials, equipment, processes and systems demonstrating their status, i.e. 5S, shadow boards, lanyards, work management, materials control including items to be removed or added such as bolts, washers, items in or items out, and management of waste arising such as swarf training and awareness information including good housekeeping for personnel involved in such activities. Product Traceability 5.13 The Contractor shall have a documented process for identification and traceability of materials and products during storage, manufacturing and delivery in accordance with relevant specified requirements The Contractor shall, where required, ensure stockists maintain a system that provides item traceability in accordance with the relevant specified requirements. Material Certification 5.15 All required certificates provided shall comply with BS EN , or Sellafield Limited Contract specific purchase documentation. The Contractor shall supply to Sellafield Ltd Original Material Mill Certificates listing the mechanical and chemical properties as required by the contract specification. Where a Supplier is not in receipt of the TRUE VERIFIED COPY OF THE ORIGINAL CERTIFICATE, the Supplier shall validate the certificate in accordance with BS EN (Name and Position) as a TRUE COPY OF THE CERTIFICATE IN OUR POSSESSION Where a product has been manufactured from a previously certified material the Contractor shall provide endorsed certificates of both material products produced by one manufacturer and reworked by another manufacturer, for example fittings made from pipe or plate, flanges made from a forging or plate The Contractor shall review and endorse the Original Material Mill Certificates or certified copies to verify conformance with the Contract Specification prior to the commencement of work. The Contractors / Suppliers authorised representative shall validate the certificate to confirm the mechanical and chemical properties comply with the requirements of the order. Stockist certificates are not acceptable when original material certificates or certified copies are specified within the Contract Specification. No information shall be deleted or otherwise obscured from the certificate, including purchaser details. Any evidence of alteration to a test certificate, or an illegible certificate shall be rejected.

28 SLM Issue 4 Effective date: 09/2017 Page 28 Verification and Inspection of Products and Services by Sellafield Ltd 5.18 Acceptance of any aspect of a product or service by Sellafield Ltd does not absolve the Contractor of his responsibility to ensure conformity to product and service requirements. Quality Grade 5.19 The Contractor shall provide Sellafield Ltd with the agreed notice period of a Quality Plan hold point requiring Sellafield Ltd attendance 5.20 To request verification of inspection and test by the Sellafield Ltd Inspection and Certification Group (ICG), the Contractor shall complete form SLF ICG Notification of Inspection and send to Sellafield Ltd Off-Site ICG mailbox ICG@ sellafieldsites.com 5.21 On-site Contractors should establish a process for goods inward inspection. The process should ensure the following: Plant and materials are received with a copy of the relevant SLF (Final Certificate of Inspection ) or equivalent certificate. Plant and materials should be accompanied by a manufacturer s delivery note and should be checked for quantities and transport damage. Plant, materials and associated certification are to be booked into an approved storage or lay down area and allocated with a unique identification number. Plant and materials that are found to be damaged or considered to be outside of specified requirements are immediately quarantined. Identification of CFSI Control of Measurement and Test Equipment 5.22 The Contractor shall maintain a register of measurement and test equipment Quality Grade The Contractor shall maintain measurement and test equipment, calibrated and traceable to International or National Standards for the duration of the contract 5.24 The Contractor shall notify the Customer of any product that may be affected by the failure of measurement and test equipment or by the measurement and test equipment failing recalibration. The Contractor should evaluate the impact on product affected by such equipment; this product should be treated as nonconforming product until demonstrated otherwise

29 SLM Issue 4 Effective date: 09/2017 Page 29 Deviation and Non-conforming Product or Process 5.25 The Contractor shall establish a documented process to identify, record, clarify and resolve technical queries with Quality Grade respect to Sellafield Ltd and/or Customer requirements prior to or during the implementation of the contracted work scope. Sellafield Ltd requirements are identified within: SLP : How do I resolve Engineering Queries SLF : Technical Query/Concession/Production Permit 5.26 The Contractor shall establish a documented process to identify, clarify, resolve and close out non-conformances, in a timely manner, throughout the life of the Contract. Sellafield Ltd requirements are identified within: SLP : How do I Monitor and Report Non-Conformance SLF : Defect/Non-Conformance Report 5.27 The Contractor shall establish a documented process to identify a request for deviations or a justification for the use of non-conforming product or service from Sellafield Ltd specified requirements. SLF : Defect/Non-Conformance Report SLF : Technical Query/Concession/Production Permit Upon identification of nonconforming product or service the Contractor shall ensure the product is clearly identified, segregated, controlled, recorded, and reported to the appropriate level of management within the organisation and then reported onwards to their Customer The Contractor and its sub-contractors should not repair work or correct spoilt work after (final) inspection by the nominated inspectorate without the prior written approval from the Customer.

30 SLM Issue 4 Effective date: 09/2017 Page 30 6 Acceptance and Release Certificate of Conformance Quality Grade 6.1 Where required, the Contractor shall supply a document certified by a competent authority - that the supplied goods or service meets the required specifications. This is also referred to as a Certificate of Compliance or Certificate of Conformity (C of C). Details required to be identified on the Certificate of Conformance, as a minimum, are: Contract / Purchase Order Number (Unique identifier) Compliance to referenced Specification (BS EN certificate) Drawing Number (if appropriate) Item identification and number of items covered under C of C Release of Goods 6.2 The Contractor shall not dispatch product identified as requiring an interim release note until authorisation has been obtained from Sellafield Ltd by the issue of a signed Sellafield Ltd Form SLF Intermediate Certificate of Inspection Form The Contractor shall not dispatch to Sellafield Ltd any product unless authorisation has been obtained from Sellafield Ltd by the issue of a signed Sellafield Ltd Form SLF Final Certificate of Inspection Form Life Time Records defined in the Contract as being required by Sellafield Ltd shall be accepted as defined in SLP : How do I control and approve Life Time Records (information handover) and its sub sets, with a name, signature and date on the front sheet of the LTR pack by both the Contractor and Sellafield Ltd prior to product release. Release of Goods on Sellafield site 6.5 Inspection checklists and associated Contractor Inspection and Test Plans will be utilised to control the release of goods manufactured on site. Records The Contractor shall ensure that all LTRs including those generated by sub- Contractors are compiled in accordance with SLP and its subsets concurrently with the activity to which they relate. Correction Fluid (Tippex) is not to be used. Mistakes should be crossed out by a single line so the previous information can still be read, signed, stamped and dated at the side of the change. 6.7 The agreed number of sets of the LTRs shall be, unless stated otherwise in the Contracts, be sent to the applicable Quality Manager for the Contract as identified at Opening Up meeting 6.8 Where Radiography is specified within the Purchase Order / Contract, the Contractor shall conform to ES_0_5260_2 General Procedure & Guidance specification for Radiographic Examination.

31 SLM Issue 4 Effective date: 09/2017 Page 31 7 Delivery and Receipt Preservation of Product 7.1 Contractors are expected to inform Sellafield Ltd of specific requirements and processes that are necessary for the ongoing maintenance and preservation of product(s) before and during use. Operations and Maintenance manuals may form part of the deliverables. 7.2 The Contractor should ensure the security of product and its constituent parts during internal processing and delivery to Sellafield Ltd. 7.3 The Contractor is responsible for establishing a specified storage area, on Sellafield site Contracts this will be provided by the SL Construction Manager. The storage area must satisfy the relevant requirements of the associated SL Specifications and must be maintained to agreed standards. The specified storage area must contain a secure quarantine area. 7.4 The Contractor shall maintain a Project Plant and Equipment Inspection and Test Plan in accordance with SLF containing the following as a minimum for each item of plant and material: Quality Grading; Safety Function Class; Relevant specifications; Contractor and location; Resource requirements; Manufacture, Inspection and Test Plan requirements; Factory acceptance test requirements; Functional test requirements; Certification requirements; Release requirements; Anticipated delivery dates

32 SLM Issue 4 Effective date: 09/2017 Page 32 Appendix A Typical Oversight & Assurance Activities Pre-Contract Contract Placement Design Activities for Oversight of Quality Assurance Opening-Up meetings to review tender submission Assessment of Contractor s resources and capability (award stage) Advising on Contractor s arrangements for oversight and assurance Advising on Contractor selection Contract Opening-Up meetings Ensure the understanding of Customer / Contract requirements, oversight and assurance arrangements Review and approval / acceptance of quality documentation including special processes Review and approval / acceptance of Quality Plan Review and approval / acceptance of Manufacturing Inspection and Test Plan (MITP) Advising on quality and technical matters Advising on manufacturing process / constructability Advising on sub-supplier selection Understanding of Customer requirements and design inputs / outputs Review of documentation and design inputs / outputs Ongoing review, validation and verification of design and development control processes

33 SLM Issue 4 Effective date: 09/2017 Page 33 Product and Service Realisation Product and Service Realisation Acceptance and Release Delivery and Receipt Defining and managing Quality roles and responsibilities (SQEP) across the Contract Contract Opening-Up meetings Review that works information has cascaded through the Supply Chain Designated Quality Interface between Customer and Contractor Specialist advice or input to resolve manufacturing and delivery issues Systems to capture Deviation / NCR / TQ / PP / Concession data Processes to input Deviation / NCR / TQ / PP / Concession data Ongoing assessment of Contractor performance Assurance the products and services meet the requirements of the Customer / Contract Ongoing approval of Contractor s SQEP resource Manufacturing Inspection and Test Plan (MITP) activities including ongoing process assurance / inspection Review and approval of inspection and test reports (and trend) Compiling and collating Life Time Records (LTR) Verification of measuring and test equipment Inspection reports Final inspection of products and services Review and approval of interim Life Time Records Certification of Quality Plan completion Certificates of release acceptance Final review and approval of Life Time Records Receipt inspection Contractor Performance Report Questionnaire

34 SLM Issue 4 Effective date: 09/2017 Page 34 Appendix B Related References The following documents are available from the Management of Contractors website. To gain access to the Management of Contractors website please get in touch with your Sellafield Ltd Contact. Reference SLSP SLP SLF SLP SLF SLSP SLF SLF SLF SLSP SLF SLP SLP SLSP Title Application of Assurance & Oversight for Project Plant & Equipment How Do I Resolve Engineering Queries Technical Query/Concession/Production Permit How do I manage construction through the Sellafield Gated Process Defect/Non-conformance Report Quality Standards for SL Projects and Contractors engaged on SL Projects Project Plant and Equipment Inspection and Test Plan Sellafield Ltd Supply Chain Management Model Supply Chain Right First Time Metrics Matrix Management of Internal and Supply Chain Quality Plan s Quality Plan (Customer Approval) How Do I Monitor and Report Non Conformances? How do I Control and approve Lifetime Records? (information handover) Sellafield Ltd. Expectations for Compilation and Submission of Lifetime Records (information handover) SLF Intermediate Certificate of Inspection (Form 5199) SLF Final Certificate of Inspection (Form 5059) SLSP SLSP SLP SLF ICG/Form/001 SLCP Nuclear Safety for the Suppliers of Goods and Services to Sellafield Ltd Guidance on managing Counterfeit, Fraudulent and Suspect Items (CFSI) How do I determine the Quality Grade of my Supply Chain Requirements Contractor request for deviation from Contract Quality Requirements ICG Notification of Inspection Form Sellafield Ltd Nuclear Safety Policy

35 SLM Issue 4 Effective date: 09/2017 Page 35 National and Regulatory Standards Reference BS EN BS ISO/IEC Title Metallic products Types of inspection documents Systems and Software Engineering Software Life Cycle Processes ISO 22301:2014 Societal security - Business continuity management systems - Requirements BS EN (all appropriate parts) BS ISO/IEC BS EN ISO 9000 BS EN ISO 9001 NS-TAST-GD-077 IAEA SF-1 Tender and Contract Specifics Reference CFMT 121 ES_1_2190 parts 1-4 ES_1_2479_1 ES_0 _5260_2 Functional Safety of Electrical/ Electronic/Programmable Electronic Safety Related Systems Software Engineering Guidelines for the Application of BS EN ISO 9001:2008 to Computer Software Quality Management Systems - Fundamentals and vocabulary Quality Management Systems Quality management Systems Requirements Supply Chain Management Arrangements for the Procurement of Nuclear Safety Related Items or Services (ONR) Fundamental Safety Principles Title Main Contractors Identification and proposed control of Sub Contractors and Suppliers. The Engineering Standard for E/E/PES Safety Measures Programmable Electronic System Based Instrumentation and Control General procedure & guidance specification for radiographic examination.

36 SLM Issue 4 Effective date: 09/2017 Page 36 Appendix C Glossary Definition Assessment Assurance Audit Capability CFSI Change Control Concessions Contract Contractor/Sub- Contractor Counterfeit Customer Deviation Flow-down Foreign Material Exclusion (FME) Fraudulent Description Process for analysing a Contractor s competencies, facilities and equipment to ensure that they have amongst other things the capability to conform to the Contract requirements, delivering products and services safely, to schedule, of the correct quality and to cost A systematic approach to confirm activities are being completed as per the requirements, to the appropriate standard and to confirm that arrangements comply with required legislation, standards and customer requirements Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled The sum of knowledge, expertise and capacity of an organisation to achieve its goals Counterfeit, Fraudulent and Suspect Items: also includes services Change control is a systematic approach to managing all changes made to a product or system. The purpose is to ensure that no unnecessary changes are made, that all changes are documented, that services are not unnecessarily disrupted and that resources are used efficiently Permission to use or release of product or service that does not conform to requirements Binding agreement between the Customer and a Contractor Supplier or individual who provides products or services in accordance with the Customer s Contract requirements. Contractor is an all-inclusive term which may be used in place of: Supplier, Contractor, Sub-Contractor or consultant Items intentionally manufactured or altered to imitate a legitimate product in order to pass themselves off as genuine. The organisation receiving the Product or Service. May be defined as Sellafield Ltd or the next tier up in the Supply Chain from the Contractor in question Departures from the originally specified requirements of a product prior to realisation. Deviations can emerge at any stage of the Supply Chain, including design, manufacturing, storage and transportation. Distribution of the Customer s Contract requirements as applicable to the specified Quality Grade to every tier of the Supply Chain where the risk associated with the procurement of product or services continues to be a Quality grade 01, 02 or 03 The process of preventing the introduction of outside debris into an area or areas where that debris poses an economic risk or safety hazard Fraudulent items are misrepresented with intent to deceive, including items with incorrect identification or false certifications.

37 SLM Issue 4 Effective date: 09/2017 Page 37 Definition Hold Point Inspector Intelligent Customer Learning from Experience (LfE) Life Time Records (LTR) Manufacturer/ Contractor/ Vendor Manufacture, Inspection and Test Plan (MITP) Non-conforming or NCR (Nonconforming Report) Nuclear Licensee Nuclear Safety Description Hold Point is a mandatory verification point beyond which a work cannot proceed without approval by the Engineer / Inspector. The work cannot proceed until the Engineer / Inspector is able to verify the quality of the completed work and releases the Hold by means of Inspection Request approval. The independent body or organisation that verifies that items or services have been designed, constructed and tested in accordance with the technical Specification. The inspection authority should have suitable competencies. As an intelligent customer, in the context of nuclear safety, the management of the facility should know what is required, should fully understand the need for a Contractor s services, should specify requirements, should supervise the work and should technically review the output before, during and after implementation. The concept of intelligent customer relates to the attributes of an organisation rather than the capabilities of individual post holders. A licensee s intelligent customer capability will be a sub-set of its core capability. See also Operational Experience (OE) Record(s) that provide documentary evidence of the research & development, design, build, construction, commissioning, decommissioning and demolition of/on a nuclear installation The supplier organisation that designs, constructs and tests items or services in accordance with a Customer s purchase order. This term includes the main manufacturer and any sub-contractors in the Supply Chain. It also encompasses the scenario where design, manufacture, and installation might be carried out by different organisations. Document which defines the sequential Quality Control, testing activities and associated arrangements that are applied to a specific scope of work or individual piece of plant or equipment Non-fulfilment of a requirement. Non-conformances can emerge at any stage of the Supply Chain, including design, manufacturing, storage and transportation. The body corporate that has been granted a Nuclear Site Licence under the Nuclear Installations Act 1965 (as amended), which permits it to carry out a defined scope of activities on a delineated site (NIA). The protection of workers, the public and the environment from undue radiation hazards by achievement of proper operating conditions, prevention of accident and the mitigation of accident consequences,. In this document safety means nuclear safety unless otherwise stated.

38 SLM Issue 4 Effective date: 09/2017 Page 38 Definition Operational Experience (OE) Product Production Permit or PP Quality Grade Quality Management System Quality Plan Root Cause Analysis Safety Culture Special Process Supply Chain Suspect Item Technical Query or TQ Technical Specification Validation Verification Description The organisation systematically and effectively collects, evaluates, and implements lessons from relevant internal and external operating experience information in a timely manner To include components, equipment (incl. free-issue / customerissued), software, maintenance, decommissioning etc Written authorisation from Sellafield Ltd, prior to production, to deviate from specified requirements A graded approach to the procurement and supply of products and services A management system to direct a unit and control an organisation with regard to quality; a combination of resources and means with which quality is realised. A document or set of documents setting out the specific quality practices, resources and sequence of activities relevant to realisation of a particular item or service. A quality plan is useful for formalising and co-ordinating the interactions of various organisations, through the identification of witness and hold points. Root cause analysis (RCA) is a method of problem solving used for identifying the root causes of faults or problems The assembly of characteristics and attitudes in organisations and individuals which establishes that, as an overriding priority, protection and safety issues receive the attention warranted by their significance. A Process that changes the shape, form, structure or final appearance of the original product The network of organisations that are involved in the different processes, and activities, that contributes to the provision of products or services to the purchaser. Indication by inspection, testing or documentation that the Product may not conform to specified standards, specifications and/or technical requirements. Additional information or investigation is needed to determine whether the suspect item is acceptable, Non-conforming, Counterfeit or Request for clarification of technical or engineering information typically contained in drawings, specifications and contract documents. The response should provide clarification but must not in its own right change design intent. 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. Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled Confirmation, through the provision of objective evidence, that the requirements have been fulfilled

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