Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 2 of 39 Contents Introduction 3 1 Nuclear Safety Requirements 5 2 Quality Management System Requirements 12 3 Resource Management 14 4 Procurement 16 5 Quality Plans 20 6 Subcontractor Control 23 7 Assurance 24 8 Deviation and Nonconforming Product or Process 26 9 Control of Measurement and Test Equipment 27 10 Design 27 11 Production and Service Provision 29 12 Specialist Procurement Requirements 33 13 Records 34 14 Definitions 35 15 References 38 16 Amendment Record 39 Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 3 of 39 Introduction Sellafield Ltd aim to deliver excellence in everything it does, operating safely, securely, reliably and predictably. To achieve this aim, Sellafield Ltd requires its supply chain to deliver products and services safely, to schedule, to the specified requirements and to the agreed cost. The purpose of this document is to define Sellafield Ltd’s Contract Quality Requirements (CQR’s) that will enable the delivery of products and services to the Sellafield Ltd associated quality grade (medium, high and very high risk). The CQR’s emphasise those elements above the latest edition of BS EN ISO 9001 that are key to successful delivery of products and services to Sellafield’s nuclear industry supply chain requirements. This document has been produced in a format that allows compliance to be demonstrated against the required clauses. In the event of any inconsistencies existing between this Contract Quality Requirements document and the Sellafield Ltd Contract, the Contract shall take precedence. Where a contractor is undertaking work on the Sellafield Ltd site; the Contractor requirements for Sellafield Ltd (3.02 Series documentation) must be adhered with in addition to the requirements outlined within this document. Quality Grade The requirements of each Quality Grade are identified using the key shown 01 02 03 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 01, Quality Grade 02 and Quality Grade 03. For the purposes of this document Quality Grade 04 is not applicable. 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 either a Quality Grade 01, 02 or 03. If the product or service being procured carries low/no risk it can therefore be classified as a Quality Grade 04; 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. Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 4 of 39 Contractor request for deviation from Contract Quality Requirements If the Contractor is unable to comply with any of the requirements defined within this document applicable to the Quality Grade requirements, the Contractor shall complete form SLF 4.06.40 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. 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 o At all levels and tiers, throughout the supply chain – raising queries and concerns as they become known o 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 o Identifying and building on best practice o Utilising LFE (Learning From Experience) to prevent issues and improve performance • Focused Improvement o Having the right measures, o Using the right tools, o Looking at the right things • Structured Problem solving o Basing decisions on data o Addressing the root cause o Implementing robust corrective actions Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 5 of 39 1 Nuclear Safety Requirements Nuclear Safety Definition – The protection of workers, the public and the environment from undue radiological hazard by achievement of proper operating conditions, prevention of accidents and the mitigation of accident consequence. 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 of failure of a product or service can impact upon the associated plant and local community. The design phase needs to concentrate on the four criteria of Criticality (control conditions to prevent a criticality), Control (prevent chemical reactions that could challenge containment), Containment (keep nuclear inventory where it should be) and Cooling (stop nuclear material overheating). Design is the first layer of defence. It is at the design stage where the most impact on Nuclear Safety can be made; therefore it is vital that any party undertaking design understand the impact of a failure. The requirements of the design then need to be transmitted into the construction phase such that the design intent can be realised via the quality of workmanship. This will involve ensuring the manufacturing, fabrication and construction trades understand how the quality of their workmanship can impact on Nuclear Safety e.g. poor installation of pipe-work may lead to loss of containment of nuclear materials. Other requirements include Construction personnel understanding the constraints of a construction site being next to Nuclear Buildings therefore there may be restrictions on the use of cranes or vibrating machinery that could affect sensitive instruments. 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. The Institute of Nuclear Power Operations (INPO) have defined ten essential traits and associated attributes of a healthy nuclear safety culture, with the goal of creating a framework for open discussion and continuing evolution of safety culture throughout the nuclear industry. Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 6 of 39 The traits are divided into three categories, the categories and their primary attributes are as follows: • Individual Commitment to Safety — Personal Accountability — Questioning Attitude — Safety Communication • Management Commitment to Safety — Leadership Accountability — Decision-Making — Respectful Work Environment • Management Systems — Continuous Learning — Problem Identification and Resolution — Environment for Raising Concerns — Work Processes Personal Accountability All individuals take personal responsibility for safety. Responsibility and authority for nuclear safety are well defined and clearly understood. Reporting relationships, positional authority, and team responsibilities emphasise the overriding importance of nuclear safety. Attributes: PA.1 Standards: Individuals understand the importance of adherence to nuclear standards. All levels of the organisation exercise accountability for shortfalls in meeting standards. PA.2 Job Ownership: Individuals understand and demonstrate personal responsibility for the behaviors and work practices that support nuclear safety. PA.3 Teamwork: Individuals and work groups communicate and coordinate their activities within and across organisational boundaries to ensure nuclear safety is maintained Questioning Attitude Individuals avoid complacency and continuously challenge existing conditions, assumptions, anomalies, and activities in order to identify discrepancies that might result in error or inappropriate action. All employees are watchful for assumptions, values, conditions, or activities that can have an undesirable effect on plant safety. Attributes: QA.1 Nuclear is Recognised as Special and Unique: Individuals understand that complex technologies can fail in unpredictable ways. Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 7 of 39 QA.2 Challenge the Unknown: Individuals stop when faced with uncertain conditions. Risks are evaluated and managed before work proceeds. QA.3 Challenge Assumptions: Individuals challenge assumptions and offer opposing views when they believe something is not correct. QA.4 Avoid Complacency: Individuals recognise and plan for the possibility of mistakes, latent issues, and inherent risk, even while expecting successful outcomes. Safety Communication Communications maintain a focus on safety. Safety communication is broad and includes plantlevel communication, job-related communication, worker-level communication, equipment labeling, operating experience, and documentation. Leaders use formal and informal communication to convey the importance of safety. The flow of information up the organisation is seen as important as the flow of information down the organisation. Attributes: CO.1 Work Process Communications: Individuals incorporate safety communications in work activities. CO.2 Bases for Decisions: Leaders ensure that the bases for operational and organisational decisions are communicated in a timely manner. CO.3 Free Flow of Information: Individuals communicate openly and candidly, both up, down, and across the organisation and with oversight, audit, and regulatory organisations. CO.4 Expectations: Leaders frequently communicate and reinforce the expectation that nuclear safety is the organisation’s overriding priority. Leadership Accountability Leaders demonstrate a commitment to safety in their decisions and behaviors. Executive and senior managers are the leading advocates of nuclear safety and demonstrate their commitment both in word and action. The nuclear safety message is communicated frequently and consistently, occasionally as a stand-alone theme. Leaders throughout the nuclear organisation set an example for safety. Corporate policies emphasise the overriding importance of nuclear safety. Attributes LA.1 Resources: Leaders ensure that personnel, equipment, procedures, and other resources are available and adequate to support nuclear safety. LA.2 Field Presence: Leaders are commonly seen in working areas of the plant observing, coaching, and reinforcing standards and expectations. Deviations from standards and expectations are corrected promptly. LA.3 Incentives, Sanctions, and Rewards: Leaders ensure incentives, sanctions, and rewards are aligned with nuclear safety policies and reinforce behaviors and outcomes that reflect safety as the overriding priority. Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 8 of 39 LA.4 Strategic Commitment to Safety: Leaders ensure plant priorities are aligned to reflect nuclear safety as the overriding priority. LA.5 Change Management: Leaders use a systematic process for evaluating and implementing change so that nuclear safety remains the overriding priority. LA.6 Roles, Responsibilities, and Authorities: Leaders clearly define roles, responsibilities, and authorities to ensure nuclear safety. LA.7 Constant Examination: Leaders ensure that nuclear safety is constantly scrutinised through a variety of monitoring techniques, including assessments of nuclear safety culture. LA.8 Leader Behaviors: Leaders exhibit behaviors that set the standard for safety. Decision-Making Decisions that support or affect nuclear safety are systematic, rigorous, and thorough. Operators are vested with the authority and understand the expectation, when faced with unexpected or uncertain conditions, to place the plant in a safe condition. Senior leaders support and reinforce conservative decisions. Attributes: DM.1 Consistent Process: Individuals use a consistent, systematic approach to make decisions. Risk insights are incorporated as appropriate. DM.2 Conservative Bias: Individuals use decision-making practices that emphasise prudent choices over those that are simply allowable. A proposed action is determined to be safe in order to proceed, rather than unsafe in order to stop. DM.3 Accountability for Decisions: Single-point accountability is maintained for nuclear safety decisions. Respectful Work Environment Trust and respect permeate the organisation, creating a respectful work environment. A high level of trust is established in the organisation, fostered, in part, through timely and accurate communication. Differing professional opinions are encouraged, discussed, and resolved in a timely manner. Employees are informed of steps taken in response to their concerns. Attributes: WE.1 Respect is Evident: Everyone is treated with dignity and respect. WE.2 Opinions are Valued: Individuals are encouraged to voice concerns, provide suggestions, and raise questions. Differing opinions are respected. WE.3 High Level of Trust: Trust is fostered among individuals and work groups throughout the organisation. WE.4 Conflict Resolution: Fair and objective methods are used to resolve conflicts. Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 9 of 39 Continuous Learning Opportunities to continuously learn are valued, sought out, and implemented. Operating experience is highly valued, and the capacity to learn from experience is well developed. Training, self-assessments, and benchmarking are used to stimulate learning and improve performance. Nuclear safety is kept under constant scrutiny through a variety of monitoring techniques, some of which provide an independent “fresh look.” Attributes: CL.1 Operating Experience: The organisation systematically and effectively collects, evaluates, and implements lessons from relevant internal and external operating experience information in a timely manner. CL.2 Self-Assessment: The organisation routinely conducts self-critical and objective assessments of its programs, practices, and performance. CL.3 Benchmarking: The organisation learns from other organisations to continuously improve knowledge, skills, and safety performance. CL.4 Training: High-quality training maintains a knowledgeable workforce and reinforces high standards for maintaining nuclear safety. Problem Identification and Resolution Issues potentially impacting safety are promptly identified, fully evaluated, and promptly addressed and corrected commensurate with their significance. Identification and resolution of a broad spectrum of problems, including organisational issues, are used to strengthen safety and improve performance. Attributes: PI.1 Identification: The organisation implements a corrective action program with a low threshold for identifying issues. Individuals identify issues completely, accurately, and in a timely manner in accordance with the program. PI.2 Evaluation: The organisation thoroughly evaluates issues to ensure that problem resolutions and solutions address causes and extents of conditions commensurate with their safety significance. PI.3 Resolution: The organisation takes effective corrective actions to address issues in a timely manner commensurate with their safety significance. PI.4 Trending: The organisation periodically analyzes information from the corrective action program and other assessments Environment for Raising Concerns A safety-conscious work environment (SCWE) is maintained where personnel feel free to raise safety concerns without fear of retaliation, intimidation, harassment, or discrimination. The station creates, maintains, and evaluates policies and processes that allow personnel to freely raise concerns. Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 10 of 39 Attributes: RC.1 SCWE Policy: The organisation implements a policy that supports individual rights and responsibilities to raise safety concerns and does not tolerate harassment, intimidation, retaliation, or discrimination for doing so. RC.2 Alternate Process for Raising Concerns: The organisation implements a process for raising and resolving concerns that is independent of line management influence. Safety issues may be raised in confidence and are resolved in a timely and effective manner. Work Processes The process of planning and controlling work activities is implemented so that safety is maintained. Work management is a deliberate process in which work is identified, selected, planned, scheduled, executed, closed, and critiqued. The entire organisation is involved in and fully supports the process. Attributes: WP.1 Work Management: The organisation implements a process of planning, controlling, and executing work activities such that nuclear safety is the overriding priority. The work process includes the identification and management of risk commensurate to the work. WP.2 Design Margins: The organisation operates and maintains equipment within design margins. Margins are carefully guarded and changed only through a systematic and rigorous process. Special attention is placed on maintaining fission product barriers, defense-in-depth, and safety-related equipment. WP.3 Documentation: The organisation creates and maintains complete, accurate, and up-to-date documentation. WP.4 Procedure Adherence: Individuals follow processes, procedures, and work instructions. Quality Grade 01 1.1 02 03 The Contractor shall establish and promote an effective Nuclear Safety Culture aligned to the traits and attributes defined above within its own organisation and that of its supply chain by: a. Ensuring a common understanding of the key aspects of Nuclear Safety within the organisation. b Providing the means by which the contractor is able to develop a Nuclear Safety Culture. c. Reinforcing a learning and questioning attitude at all levels of the organisation about Nuclear Safety. 1.2 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. 1.3 The Contractor shall ensure that the ten traits of a Nuclear Safety are promoted throughout the organisation so that all Personnel are aware of them and understand them. Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 11 of 39 1.4 The Contractor shall ensure that Personnel are aware of the implications of Suspect and Counterfeit products being deployed on the Sellafield site. 1.5 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. Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 12 of 39 Quality Grade 2 Quality Management System Requirements 01 02 03 2.1 All Contractors shall maintain a quality management system that is compliant to the latest edition of BS EN ISO 9001 standard or equivalent, and which has been certified by a United Kingdom Accreditation Service(UKAS), accredited Certification body or International accepted equivalent 2.2 The Contractor shall monitor, review and update its quality management systems as necessary to comply with Good Industry Practice and to ensure continued certification. 2.3 At contract award the Contractor shall have implemented their quality management system 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 available to the Customer within 10 working days of contract award for formal audit if requested by the Customer. 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. 2.6 The Contractor shall submit any changes it considers necessary to its quality management systems to the Customer for approval if such a change will impact upon product quality or affect (or is likely to affect) or will lead (or is likely to lead) to the loss of the Contractor’s Certification. The Customer may only withhold its consent to such a change if, in its reasonable opinion, the proposed change does not comply with: a internationally accepted quality management systems or Good Industry Practice at the time of the request; or b any other obligations in relation to quality management systems placed on the Contractor under the Contract. 2.7 When responding to any Contractor request for the Customer approval of changes to the Contractor's quality management systems, the Customer shall respond in writing; and provide any reasons for determination that the Contractor's proposed changes to its quality management systems are unsuitable. Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 2.8 Issue 3 Effective date: 06/2014 Page 13 of 39 The Contractor shall provide evidence of compliance to the Contract Quality Requirements to Sellafield Ltd upon request 2.9 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). 2.10 The Contractor shall ensure that all Personnel executing the contracted scope of work are aware of and understand the management system arrangements and any amendments relevant to the scope of work. 2.11 The Contractor shall ensure that documentation requiring submittal to the customer for information or for review and acceptance shall be submitted as detailed in the Contract and Sellafield Ltd Contract Quality Requirements. 2.12 The Contractor’s procedure for controlling documents between Subcontractors and the customer shall ensure documents are clearly identifiable to each Subcontractor. Version control of documents between the Contractor, Subcontractor and the customer shall be appropriately managed. 2.13 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. 2.14 The Contractor shall have a documented process for Learning from Experience to demonstrate improvement, and be able to show effective implementation 2.15 In addition to the Contract Quality Requirements, Contractors engaged on Sellafield Ltd projects shall follow SLSP 1.10.315.01, “Quality Standards for SL Projects and Contractors engaged on SL Projects”, and its subsets as stated in the Contract. Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 14 of 39 Quality Grade 3 Resource Management 3.1 01 02 03 The Contractor shall implement an induction course. 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 • Safety requirements • Security requirements • Overview of the works • Mandatory procedures • Standards and Specifications requirements briefs 3.2 The Contractor shall determine and provide the appropriate number of SQEPed resources required to deliver the contracted scope of work and agree the levels with the Customer. 3.3 The Contractor shall ensure that all Personnel they assign to undertaking work for the customer are suitably qualified and experienced to deliver the assigned work. There should be a clear auditable trail that demonstrates that the contractor's staff is equally as "SQEP" as licensee staff would be for the same role. 3.4 The Contractor shall implement and maintain a competency/training register supported by appropriate training and qualification records. The register shall identify: • All personnel engaged on the works • Role Specification • Status of training received for each individual • Experience of each individual • Forward Plan to close out identified competency requirements 3.5 The Contractor shall routinely perform documented reviews of personnel to maintain competency. 3.6 The Contractor shall notify the customer 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. 3.7 The Contractor shall, upon request, provide documented evidence of Personnel competency to Sellafield Ltd. Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 15 of 39 3.8 Sellafield Ltd reserves the right to interview Personnel controlling quality related activities. 3.9 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. 3.10 The Contractor shall notify the Customer formally of any organisational changes that could impact on environmental, health and safety, security and quality performance. 3.11 The Contractor shall be able to demonstrate the qualification and independence of Personnel verifying or inspecting work from those performing the work. 3.12 All Inspection & Test quality control personnel deployed on the works are suitably experienced and shall be in possession of nationally recognised qualifications 3.13 All testing and inspection practitioners shall be experienced in the application of the technique to the specific material. Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 16 of 39 Quality Grade 4 Procurement 01 02 03 A Graded Approach to Procurement Sellafield Ltd implements a graded approach to the procurement of goods and services within the supply chain (SLP 4.06.05: “How do I determine the Quality Grade of my Supply Chain Requirements”). This graded approach ensures that the appropriate levels of assurance and oversight are deployed, commensurate with the level of risk. 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 products or services directly to Sellafield Ltd and requiring further information on Sellafield Ltd’s graded approach to procurement may refer to Sellafield Ltd procedure SLP 4.06.05. The Quality Grades have been developed as a risk mitigation measure. Quality Grade 01 for very high risk and Quality Grade 02 for high risk products and services require Sellafield Ltd assurance and oversight activities at the contractor’s works or locations of the activity and shall require documentation such as quality plans, Inspection and Test plans or method statements to document the quality requirements. These Quality Grades shall also require surveillances and reviews by appropriate personnel. Quality Grade 03 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. Quality Grade 03 shall require surveillances and reviews by appropriate suitably qualified experienced personnel (SQEP). Sellafield Ltd utilises one additional Quality Grade code that may be applicable for the direct supply of product to Sellafield Ltd. Quality Grade 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 03 requirements for this code. If the product or service being procured can be demonstrated by a supplier to carry low/no risk, they may determine to assign a Quality Grade 04 (SLP 4.06.05: How do I determine the Quality Grade of my Supply Chain Requirements). Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 17 of 39 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 4.06.05. However, attention is drawn to the table in the SLP with respect to Risk Mitigation Measures which states that a Quality Grade 04 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 4.1 The Contractor shall implement a graded approach in accordance to the Sellafield Ltd SLP 4.06.05 for the procurement of products and services to mitigate the risk of failure. For additional detail please see above “A Graded Approach to Procurement”. Purchasing Information 4.2 The Contractor shall ensure that purchasing information accurately specifies the product or service to be purchased. 4.3 The Contractor shall ensure that the requirements of the contract, the Sellafield Ltd Contract Quality Requirements, the appropriate standards, and necessary requirements to deliver the products and services specified are flowed to all tiers of the Contractor’s supply chain, and that understanding is tested. 4.4 The Contractor shall ensure the purchasing information accurately specifies the requirements for acceptance of products and services, to include as applicable: • • • • • • • • • • • Reference to this CQR Quality Grade Specification(s) 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 4.5 The Contractor shall provide copies of unpriced purchase information to Sellafield Ltd upon request. 4.6 Where agreed at the Contract opening up meeting, copies of purchase information raised by the Contractor which is equivalent to Quality Grade 01/02 shall be sent to ICG@sellafieldsites.com Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 18 of 39 Contractor / Subcontractor Selection 4.7 The Contractor shall have a process for subcontractor selection through 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. 4.8 Instruction from Sellafield Ltd to use a specific Subcontractor does not absolve the Contractor from completing an evaluation of the Subcontractor’s capabilities to meet the requirements and commitments of the contract. 4.9 The Contractor shall assess the subcontractor’s capability to plan and meet the required capacities beyond existing or new contracts. 4.10 The Contractor shall ensure that any weaknesses identified during tender assessment are managed post contract award. 4.11 Sellafield Ltd reserves the right to review the Contractors supplier evaluation processes. Review of Contract Requirements 4.12 The Contractor shall ensure that all contract requirements for the scope of work are reviewed, agreed and understood prior to the commencement of work both within their own organisation and their supply chain. 4.13 The Contractor shall confirm the understanding of the works information package/ Purchase Orders via opening up meetings held with their subcontractors and explain each clause of the specification to ensure full understanding of the requirements. Where the contract includes the following elements the review shall as a minimum include the following:• • • • • • • • • • • • 4.14 Project/Contract Management Commercial Health and Safety Quality (including Nuclear Safety and Specification Awareness Briefs) Project Controls (planning, programme and costs) Risk Engineering Construction Commissioning Operations and Maintenance Provision of product samples (when requested) Life Time Records (LTRs) The Contractor shall establish a process for ongoing contract review throughout the life of the contract. Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 4.15 Issue 3 Effective date: 06/2014 Page 19 of 39 Records of the ongoing reviews and the conclusion reached shall be retained and form part of the lifetime record. Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 20 of 39 Quality Grade 5 Quality Plans02 01 02 03 02 5.1 The contractor will agree the use of Quality Plans, Inspection and Test Plans and Method Statements with the customer at the Opening up Meeting. From this point on in this document these will be known as Quality Plan(s) however the requirements apply also to Inspection and Test Plans and Method Statements. Refer to SLSP 2.15.01.01 and associated forms. 5.2 The distribution for review and approval of Quality Plans and/or Inspection and Test Plans shall be agreed at the start up/kick off meeting for the Contract, Project, task specific purchase orders or operations. 5.3 The Contractor shall ensure a Quality Plan and/or Inspection and Test Plans (or Quality Plans) is/are in place for the contracted scope of work. 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 SLF 1.10.315.13. 5.4 Dependent upon the size and complexity of the work scope it may be more appropriate to generate more than one quality plan. In these instances a top level Quality Plan should be prepared for the identified scope and reference each individual sub-Quality Plan and 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. 5.5 The Contractor shall submit the quality plan(s) and Inspection and Test Plans to the customer for acceptance within 10 working days of receipt of the contract. 5.6 The Contractor shall not commence work identified in the quality plan and Inspection and Test Plans prior to confirmation of acceptance by the customer. 5.7 The Contractor shall document in quality plans the controls to be applied to its Subcontractors. Any change to an approved/accepted quality or Inspection and Test Plans plan shall be resubmitted to the customer for approval and/or acceptance. 5.8 Specialist processes within the specification shall be identified within the quality plan and Inspection and Test Plans. These will require approval by Sellafield Ltd. Typical special processes include but are not limited to welding, pipe work bending, heat treatment, nondestructive testing, material finishes and concrete mix design. 5.9 For products and services, the quality plan and /or Inspection and Test Plans shall conform to the following Sellafield Ltd criteria: 5.9.1 The quality plan and /or Inspection and Test Plans shall be prepared listing the Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 21 of 39 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. 5.9.2 The quality plan and Inspection and/or Test Plans shall identify against activities all applicable procedures, controlling arrangements, accountability for delivery and associated records. The wording and output of the activity shall be clear, concise and unambiguous. 5.9.3 The quality plan and Inspection and/or Test Plans shall identify the minimum records to be included in the lifetime records. These records shall be reviewed, approved and accepted in accordance with the specification and contract requirements. 5.9.4 Sellafield Ltd reserves the right to identify hold 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. 5.9.5 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 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 R2(#) Hold point H Approval AP Surveillance S (#) Where ‘sample’ is identified, the percentage (%) shall be defined with the code for example, R2 (10) = 10% sample review. The initial assessment levels of A2, W2 and R2 are 100%, only reducing to predetermined lower % rating and surveillance when Sellafield Limited is assured the Contractor is meeting and maintaining the required standard. Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 22 of 39 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. 5.9.6 The quality plan and 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 Subcontractor reference number if applicable) • Plant item number or material master number • Scope of work the quality plan covers • Activity codes and description • SQEPed nominated roles for signing off the quality plan activities • Quality plan acceptance – (names, signatures and dates) • Final sign off when the quality plan is complete 5.9.7 The documentation sheet shall identify all standards and specifications applicable to the scope of work 5.9.8 The activity sheets shall identify activities and activity codes, documents, nominated roles and records required to be generated to be included in the lifetime records. 5.9.9 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 lifetime records. Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 23 of 39 Quality Grade 6 Subcontractor Control 01 02 03 6.1 The Contractor shall ensure that the full extent of their supply chain has a clear understanding of the Sellafield Ltd contract Technical and Quality specified requirements. 6.2 If the Contractor subcontracts work, the Contractor is responsible for controlling the scope of work in accordance with the associated Quality grade and the specified requirements 6.3 The Contractor shall implement a process for ongoing verification and monitoring of their Subcontractors to ensure that they are delivering products and services safely, to schedule, to the specified requirements and to the agreed cost. 6.4 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 coding in accordance with SLF 1.10.315.13 to identify the type and level of assurance to be applied by the Contractor to each subcontract. 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 subcontractor. The Contractor shall submit the diagram to the Customer with the tender for acceptance. The diagram shall be maintained throughout the lifetime of the contract. 6.5 The Contractor supplying products or services directly to Sellafield Ltd shall, in accordance with the Contract, provide for acceptance a schedule of intended Subcontractors, using Sellafield Ltd form CFMT 121 – “Main Contractors identification and proposed control of Sub Contractors and Suppliers.” The Contractor shall only Subcontract work in accordance with the agreed schedule submitted with the tender or in accordance with agreed changes following submission of a revised schedule. 6.6 The Contractor shall provide to the customer details and justifications of any proposed increase or reduction in the control over its Subcontractors or replacement of any Subcontractors. Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 24 of 39 Quality Grade 7 Assurance 01 02 03 Sellafield Ltd Oversight 7.1 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 subcontracted work. Oversight may be through Qualification, inspection, verification, surveillance and formal audit. The Contractor shall ensure that its Subcontractors are informed of this requirement. Contractor Oversight 7.2. The Contractor shall document and establish Subcontractor assurance and oversight arrangements to ensure compliance with the Sellafield Ltd specifications, standards and Contract Quality Requirements. These arrangements shall be tailored to mitigate risk to Nuclear Safety. 7.3 The contractor shall develop and implement a risk based assurance programme which aligns to the graded approach to procurement. The audit programme shall cover the scope of work to be undertaken by the Contractor during each financial year 7.4 The Customer shall be afforded, with reasonable notice, unrestricted access to the Contractor’s or Subcontractor’s facilities to carry out oversight. 7.5 Upon request, the Contractor shall report progress against their assurance programme to Sellafield Ltd. 7.6 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. Management Review 7.7 Upon request, the Contractor shall provide Sellafield Ltd with copies of Management Review records relevant to the contract work scope. 7.8 The Contractor shall notify Sellafield Ltd of any Management Review actions which will affect compliance with contractual requirements. Management Review output shall identify responsible persons and due dates for completion of agreed action. Performance Measurement 7.9 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 Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 25 of 39 scopes. The metrics shall as a minimum measure the Contractor’s safety, schedule, quality and cost performance. 7.10 The Contractor shall report the agreed cumulative metrics to the Customer at each financial period end. The Contractor shall report subcontractor performance to Sellafield Ltd using Sellafield Ltd form SLF 1.10.315.14. 7.11 The Contractor shall cascade the metrics to its Subcontractors to measure their performance. Upon request, the metric data shall be shared with Sellafield Ltd for the purpose of measurement of supply chain performance. 7.12 The Contractor shall ensure specific, measurable, achievable, realistic and time bound (SMART) action is taken if Subcontractor performance is not achieving the required standard or upon the identification of a deteriorating and/or adverse trends. Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 26 of 39 Quality Grade 8 Deviation and Nonconforming Product or Process 01 02 03 8.1 The Contractor shall establish a documented process to identify record, clarify and resolve technical problems with respect to Sellafield Ltd and/or customer requirements prior to or during the implementation of the contracted work scope. 8.2 The Contractor shall establish a documented process to identify, clarify, resolve and close out non-conformances throughout the life of the contract. 8.3 The Contractor shall establish a documented process to identify a request for deviations or a justification for the use of non conforming product from Sellafield Ltd specified requirements, aligned with • • • SLP 1.02.18 How do I resolve engineering queries, SLP 2.15.04 How Do I Monitor and Report Non Conformances? SLF 1.03.124 Defect/Non conformance Report For direct Sellafield Ltd contracts completed requests should be submitted to the Customer representative as agreed at the opening up meeting. All the documents shall be marked with the Sellafield Ltd contract number and project number (if applicable). 8.4 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. 8.5 The Contractor shall establish a process to review the cumulative effect of non-conformances, Technical Queries and concessions raised. The output of these reviews must be submitted to the Sellafield Ltd Design Authority. 8.6 The Contractor and its Subcontractors shall not repair work or correct spoilt work after (final) inspection by the nominated inspectorate without the prior written approval from Sellafield Ltd. Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 27 of 39 Quality Grade 9 Control of Measurement & Test Equipment 01 02 03 9.1 The Contractor shall maintain a register of measurement and test equipment. 9.2 The Contractor shall maintain measurement and test equipment, calibrated and traceable to International or national standards for the duration of the contract 9.3 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 shall evaluate the impact on product affected by such equipment; this product shall be treated as nonconforming product until demonstrated otherwise Quality Grade 10 Design 01 02 03 Control of Design 10.1 The Contractor shall ensure that all design interfaces are clearly defined and controlled. 10.2 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. 10.3 The Contractor shall ensure that all design documents and design 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. 10.4 The Contractor shall ensure that IT software used in analysis and computation of high risk activities is acceptance tested, is validated, has a test plan, and is not used beyond its life cycle without appropriate validation. Design Review Requirements 10.5 When the design responsibility lies with the Contractor as defined within the contract, the Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 28 of 39 Contractor shall identify and implement their proposed design reviews on a quality plan that has to be accepted by the Customer prior to the commencement of work. 10.6 Third party design verification activities shall be documented and included within a Quality plan to ensure that responsibilities and communication interfaces are clearly defined. 10.7 The Contractor shall submit all documents to be considered at design review to the Customer in a fully approved state at least 10 working days prior to the design review 10.8 Sellafield Ltd reserves the right to participate in Contractor design reviews. 10.9 Sellafield Ltd reserves the right to identify any design activity which requires confirmation or third party verification. 10.10 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. 10.11 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. Design Output, Review, Checking and Approval 10.12 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. 10.13 Design Output, whether in electronic or paper form, shall be considered as Lifetime Records and delivered in accordance with Section 13 Records. Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 29 of 39 11 Production and Service Provision Quality Grade 01 Product Traceability 02 03 11.1 The Contractor shall have a documented process for identification and traceability of products during storage, manufacturing and delivery in accordance with relevant specified requirements. 11.2 The Contractor shall, where required ensure stockists maintain a system that provides item traceability in accordance with the relevant specified requirements. Quality Grade Management of Suspect and Counterfeit Products 01 02 03 11.3 The Contractor shall ensure that processes are in place to mitigate the risk of Suspect and Counterfeit products being deployed to Sellafield Ltd. The processes shall include identification of Suspect and Counterfeit products, assurance of product source, selection of suppliers and verification that purchased products meet the specified requirements. 11.4 In the event of suspect or counterfeit products being found the Contractor shall immediately notify the Customer in case a similar item is in use, and initiate the Non Conformity process as described in section 8 11.5 The Contractor shall ensure that processes are in place to control and document the disposition of products identified as Suspect. Sellafield Ltd shall be provided records of the dispositions of Suspect products, as agreed at the opening up meeting. Quality Grade Mill Certification 01 02 03 11.6 The Contractor shall supply to Sellafield Ltd Original Material Mill Certificates listing the mechanical and chemical properties as required by the contract specification. Where this is not possible copies shall be taken and endorsed by authorised Personnel in red ink as “verified true certified copies of the original”. 11.7 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. Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 30 of 39 11.8 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. 11.9 Stockist certificates are not acceptable when Original Material Mill Certificates or certified copies are specified within the contract specification. 11.10 The Contractor’s authorised personnel reviewing Original Material Mill Certificates for conformity shall be suitably qualified and experienced to perform such reviews. Quality Grade Certificate of Conformance 01 02 03 11.11 Where required, the Contractor shall supply a document certified by a competent authority that the supplied good or service meets the required specifications. This is also referred to as a certificate of compliance or certificate of conformity. 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 10204 certificate) Drawing Number (if appropriate) Item identification and number of items covered under C of C Quality Grade Verification and Inspection of Products and Services by Sellafield Ltd. 01 02 03 11.12 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. 11.13 The Contractor shall provide Sellafield Ltd with a minimum of three working day’s notice of a Quality Plan hold point requiring Sellafield Ltd attendance within the UK. 11.14 The Contractor shall provide Sellafield Ltd with a minimum of ten working day’s notice of a Quality plan hold point requiring Sellafield Ltd attendance outside the UK. 11.15 To request verification of inspection and test by Sellafield Ltd Inspection and Certification Group (ICG), the Contractor shall complete form ICG/Form/001 – ICG Notification of Inspection and send to Sellafield Ltd Off Site ICG mailbox ICG@sellafieldsites.com 11.16 The Contractor shall establish a process for goods inward inspection. The process shall ensure the following: • Plant and materials are received with a copy of the relevant 5059 (Final Certificate of Inspection) or equivalent certificate, Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 • • • Issue 3 Effective date: 06/2014 Page 31 of 39 Plant and materials shall be accompanied by a manufacturer’s Delivery note and should be checked for quantities and transport damage. Plant, materials and associated certification are 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. Quality Grade 01 Release of Goods 02 03 11.17 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 2.15.02.04 – “Intermediate Certificate of Inspection (Form 5199)”. 11.18 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 2.15.02.05 – “Final Certificate of Inspection (Form 5059)”. 11.19 Lifetime Records defined in the contract as being required by Sellafield Ltd shall be accepted as defined in SLP 2.15.05, “How do I control and approve Lifetime 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 Quality Grade Release of Goods on Sellafield site 01 02 03 11.20 Inspection checklists and associated contractor inspection and test plans will be utilised to control the release of goods manufactured on site. Quality Grade Preservation of Product 01 02 03 11.21 The Contractor shall ensure the security of product and its constituent parts during internal processing and delivery to the Customer. 11.22 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. 11.23 The Contractor shall maintain a plant and materials schedule (SLF 1.10.315.07) containing the following as a minimum for each item of plant and material: • Quality Grading; • Safety Function class; • Relevant Specifications; • Supplier and location; • Resource requirements; • Inspection and test plan requirements; Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 • • • • • Issue 3 Effective date: 06/2014 Page 32 of 39 Factory acceptance test requirements; Functional test requirements; Certification requirements; Release requirements; Anticipated delivery dates 11.24 The Contractor shall have a Foreign Materials exclusion process. The process shall include but is not limited to the following: • Identification as to whether Foreign Materials exclusion 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 Foreign Materials exclusion 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. Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 33 of 39 12 Specialist Procurement Requirements Quality Grade Software (including Programmable Electronic Systems – PES) 01 02 03 12.1 As a minimum, where the Contract includes design, 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 9001:2008 to Computer Software is applicable together with BS ISO/ IEC 12207 Systems and Software Engineering – Software Life Cycle Processes. 12.2 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. Quality Grade 01 02 03 12.3 Where the Contract includes the design, development, 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 part 1 – 4: The Engineering standard for Electrical, Electronic and Programmable Electronic (E/E/PE) Safety Measures. 12.4 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 61508 (all appropriate parts) – “Functional Safety of Electrical/ Electronic/Programmable Electronic Safety Related Systems”. Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 34 of 39 Quality Grade 13 Records 01 02 03 03 13.1 The Contractor shall ensure that all Lifetime Records including those generated by Subcontractors are compiled in accordance with SLP 2.15.05 and its subsets concurrently with the activity to which they relate. 13.2 One set of the LTRs after acceptance by Sellafield Ltd shall be unless stated otherwise in the contract documents be sent to: Sellafield Ltd Off Site Inspection and Certification Group Hinton House Risley Warrington WA3 6GR 13.3 Where radiography is required, the Contractor shall conform to ES_0_5260_2 General Procedure & Guidance specification for radiographic examination. Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 35 of 39 14 Definitions The Sellafield Ltd Contract Quality Requirements have been written using the standard management system vocabulary as defined in BS EN ISO9000:2005 – “Quality Management Systems Fundamentals and Vocabulary” with additional terms defined where required. Audit - systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled Authorised individual - An individual with documented permission to undertake the activity Assurance - 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. Business Continuity - Holistic management process that identifies potential threats to an organisation and the impacts to business operations that those threats, if realised, might cause, and which provides a framework for building organisational resilience with the capability for an effective response that safeguards the interests of its key stakeholders, reputation, brand and value-creating activities. Certification - Carried out to ensure that customers receive what they have specified in their contract documents, and to formalise the transfer of acceptance information. Certified -Authoritatively or officially attested or confirmed as being genuine or true as represented, or as complying or meeting specified requirements or standards. Certificate of Conformance -A document certified by a competent authority that the supplied good or service meets the required specifications. Also called a certificate of compliance or certificate of conformity. Concession – Permission to use or release of product or service that does not conform to requirements Contract – Binding agreement between Sellafield Ltd and a Contractor Contract Review – Process used by an organisation to review that contract supplied documentation (works information pack) is adequate to enable successful delivery of a specific scope of work. Contractor/Sub contractor - Supplier or individual who provides products or services in accordance with the Sellafield Ltd contract requirements. Contractor is an all-inclusive term used in place of: supplier, contractor, sub contractor or consultant. Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 36 of 39 Corrective action - Action to eliminate the cause of a detected nonconformity or other undesirable situation Counterfeit – A copy or substitute product whose material, performance or characteristics are knowingly misrepresented by the supplier. Customer –A customer is the organisation receiving the product or service. In using this document a customer may be Sellafield Ltd or the next tier up in the supply chain from the contractor in question. Deviation - Departure from the originally specified requirements of a product prior to realisation Foreign Material - Material that is not part of the system or component as designed, such as dirt, debris, broken or missing parts, oil, slag, tools, rags, chemicals, lapping compounds, grinding particles and PVC bags/sheets, and any other items that could affect the intended operation of the system or component. Inspection – conformity evaluation by observation and judgment accompanied as appropriate by measurement, testing or gauging Inspection & Test Plan - Document which defines the sequential quality control, testing activities and associated arrangements that are to be applied to a specific scope of work or individual piece of plant and equipment Lifetime Records – Record(s) that provide documentary evidence of the research & development, design, build, construction, commissioning, decommissioning and demolition of/on a nuclear installation. Management Review - Regular documented systematic reviews by top management to evaluate the suitability, adequacy, effectiveness and efficiency of the quality management system. Material Mill Certificate(Original) - Issued by the material manufacturer with a coloured letterhead, original authorised signature, embossed mark, watermark etc. to prove it is an original. The certificate shall meet the requirements of the most current edition of BS EN 10204, certificate type 3.1. Material Mill Certificate(Copy) - A photocopy of an Original Material Mill Certificate endorsed in red ink by an authorised individual, inspector, third party inspector or QA representative by the manufacturer’s approved representative declaring the document as a “true certified copy of the original mill certificate”. Measurement and Test Equipment - Tools, gauges, instruments, and other measuring and test equipment used for activities affecting quality that are required to be controlled, calibrated at specific periods, adjusted by approved Personnel or approved calibration laboratories, and maintained to required accuracy limits. Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 37 of 39 Nonconformity - Non-fulfillment of a requirement Nuclear Safety Culture - An organisation’s values and behaviours, modelled by its leaders and internalised by its members, that serve to make nuclear safety the overriding priority at all times. Organisational Change - A structured and cascading approach to transitioning individuals, teams, suppliers, and Subcontractors from a current state to a future state when change becomes necessary. Preventive action - action to eliminate the cause of a potential nonconformity or other undesirable potential situation Production Permit - Is a written authorisation from Sellafield Ltd, prior to production, to deviate from specified requirements. Quality Grade – A grade indicating the extent that quality assurance and control shall be applied to a product or service based on the level of risk associated with failure. Quality Plan – A document specifying which procedures and associated resources shall be applied by whom and when to a specific project, product, process or contract Release Certificate (Intermediate) SLF 2.15.02.04 (5199) - Certificate that confirms service/supplied goods meet specification, drawings, and technical requirements of the contract (Sub contractor to Contractor) Release Certificate (Final) SLF 2.15.02.05 (5059) - Certificate that confirms service/supplied goods meet specification, drawings, and technical requirements of the contract (Contractor to Sellafield Ltd) Suspect – Indicated by inspection, testing or documentation that the product may not conform to specified requirements. SQEP – Suitably Qualified Experienced Person Technical Query - A Technical Query (TQ) is a 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. Verification - Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled Validation - Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled Works Information Pack - Contract documentation supplied by SL or a contractor to their supply chain, relevant to the specific requirements of a project/contract that enables successful delivery. Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 38 of 39 15 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 Title SLP 1.02.18 How do I resolve engineering queries SLF 1.02.18.01 Technical Query/Concession/Production Permit SLP 1.03.01 How do I manage construction SLF 1.03.124 Defect/Non conformance Report SLSP 1.10.315.01 Quality Standards for SL Projects and Contractors engaged on SL Projects SLF 1.10.315.07 Project Plant and Equipment Inspection and Test Plan SLF 1.10.315.13 Sellafield Ltd Supply Chain Management Model SLF 1.10.315.14 Supply Chain Right First Time Metrics Matrix SLP 2.15.04 How Do I Monitor and Report Non Conformances? SLP 2.15.05 How do I Control and approve Lifetime Records? (information handover) SLSP 2.15.01.01 Management of Internal and Supply Chain Quality Plans SLF 2.15.01.01 Quality Plan (Customer Approval) SLF 2.15.01.04 Intermediate Certificate of Inspection (Form 5199) SLF 2.15.01.05 Final Certificate of Inspection (Form 5059) SLP 4.06.05 How do I determine the Quality Grade of my Supply Chain Requirements SLF 4.06.40 Contractor request for deviation from Contract Quality Requirements ICG/Form/001 ICG Notification of Inspection Form Nuclear Safety Policy Sellafield Ltd Nuclear Safety Policy Exemplars available on Sellafield Ltd Supplier Useful Information website: http://suppliers.sellafieldsites.com/useful-information/contract-quality-requirements/ Reference Title SLF 2.15.01.01 Quality Plan N/A List Of Supplier Documentation / Supplier Document Register / SDRL N/A Cross Reference Matrix (Compliance data) N/A Life Time Records Dossier Index N/A Life Time Records Sub Index National Standards Reference BS EN 61508 (all appropriate parts) Title Functional Safety of Electrical/ Electronic/Programmable Electronic Safety Related Systems Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014 SLM 4.06.02 Issue 3 Effective date: 06/2014 Page 39 of 39 BS ISO/IEC 90003 Software Engineering Guidelines for the Application of BS EN ISO 9001:2008 to Computer Software BS ISO/IEC 12207 Systems and Software Engineering – Software Life Cycle Processes BS EN ISO 9000:2005 Quality Management Systems-Fundamentals and vocabulary BS EN 10204 Metallic products Types of inspection documents Tender and Contract Specific Documents Reference Title CFMT 121 Main Contractors Identification and proposed control of Sub Contractors and Suppliers. ES_1_2190 parts 1-4 The Engineering Standard for E/E/PES Safety Measures ES_1_2479_1 Programmable Electronic System Based Instrumentation and Control ES_0_5260_2 General procedure & guidance specification for radiographic examination. 16 Amendment Record Issue 2 to Issue 3 Date of amendment Section or paragraph amended Details of amendment May 2014: Whole document Whole document revised on the basis of new requirements from LFE. Sellafield Ltd, Registered in England number 1002607 SLF 4.05.03 Issue 8 Effective date 04/2014