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1 ONR GUIDE LC17 Management Systems Document Type: ONR Nuclear Safety Technical Inspection Guide Unique Document ID and Revision No: NS-INSP-GD-017 Revision 2 Date Issued: November 2012 Review Date: November 2015 Approved by: Derek Lacey Director Nuclear Policy, Strategy & Assurance Group Record Reference: Trim Folder (2012/186538) Revision commentary: In July 2011, the (ONR) varied standard site licence condition 17 in order to transpose the obligation in Article 6 paragraph 4 of European Council Directive 2009/71/EURATOM into UK law. The principal change is that a duty is now placed on licensees to establish and implement management systems which give due priority to safety. This means that all management systems (e.g. safety, environmental quality, financial or commercial) must now give due priority to nuclear safety. In recognition of this change, LC 17 is now titled management systems rather than quality assurance. In addition, LC 17 (2) Quality Assurance arrangements now refers to quality management arrangements to reflect modern terminology. In revising LC17 to reflect these changes, ONR has also taken the opportunity to incorporate revisions to quality management system standards which have been introduced since the guidance was last issued. TABLE OF CONTENT 1. INTRODUCTION PURPOSE AND SCOPE LICENCE CONDITION PURPOSE OF THE LICENCE CONDITION GUIDANCE ON ARRANGEMENTS FOR LC GUIDANCE ON INSPECTION OF ARRANGEMENTS GUIDANCE ON INSPECTION OF IMPLEMENTATION OF ARRANGEMENTS OTHER SOURCES OF INFORMATION Crown copyright. If you wish to reuse this information visit for details. You may reuse this information (excluding logos) free of charge in any format or medium, under the terms of the Open Government Licence. To view the licence visit write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or Page 1 of 11 Some images and illustrations may not be owned by the Crown so cannot be reproduced without permission of the copyright owner. Enquiries should be sent to For GEN-DOC-TEMP-002 published documents, Rev the 0 November electronic 2012 copy on the ONR website remains the most current publically available version and copying or printing renders this document uncontrolled.

2 1. INTRODUCTION 1.1 Many of the licence conditions attached to the standard nuclear site licence require, or imply, that licensees should make arrangements to comply with regulatory obligations under the conditions. ONR inspects compliance with licence conditions, and also with the arrangements made under them, to judge the suitability of the arrangements made and the adequacy of their implementation. Most of the standard licence conditions are goal-setting, and do not prescribe in detail what the licensees' arrangements should contain; this is the responsibility of the duty-holder who remains responsible for safety. To support inspectors undertaking compliance inspection, ONR produces a suite of guides to assist inspectors to make regulatory judgements and decisions in relation to the adequacy of compliance, and the safety of activities on the site. This inspection guide is one of the suite of documents provided by ONR for this purpose. 2. PURPOSE AND SCOPE 2.1 The purpose of this guidance is to facilitate a consistent and effective approach to Licence Condition (LC) 17 compliance inspection. It describes ONR s expectations for adequate quality management arrangements and should be used by Inspectors when carrying out their duties in this area. 2.2 The guidance consists of three main elements which will help Inspectors plan their site inspection programmes and LC 17 compliance inspections. Section 4 provides a brief overview to help Inspectors fully understand the scope of the arrangements needed to fulfil the requirements of LC 17. Section 5 provides more detailed guidance that Inspectors should use to judge the adequacy of the licensee s LC 17 arrangements and their implementation. Section 6 seeks to provide practical guidance on approaches that an Inspector may take to organising inspections of the topics addressed within the LC 17 arrangements. 2.3 The guidance contained in this document is consistent with IAEA Safety Standard No GS- R-3 (The Management System for Facilities and Activities) and is applicable to the activities of all licensees. 3. LICENCE CONDITION Licence Condition 17 Management Systems 17(1) Without prejudice to any other requirements of the conditions attached to this licence, the licensee shall establish and implement management systems which give due priority to safety. 17(2) The licensee shall, within its management systems, make and implement adequate quality management arrangements in respect of all matters which may affect safety. 17(3) The licensee shall submit to the Executive for approval such part or parts of the aforesaid management systems or part or parts of the aforesaid quality management arrangements as the Executive may specify. 17(4) The licensee shall ensure that once approved no alteration or amendment is made to the approved management systems or approved quality management arrangements unless the Executive has approved the alteration or amendment. 17(5) The licensee shall furnish to the Executive such copies of records or documents made in connection with the aforesaid quality management arrangements as the Executive may specify. Page 2 of 11

3 4. PURPOSE OF THE LICENCE CONDITION 4.1 The purpose of this licence condition is to ensure that all the licensee s management systems give due priority to safety 1 so that any actions or decisions taken do not have an adverse effect on safety. It also requires the licensee to apply quality management principles to all activities that may affect safety. This includes those associated with the procurement, design, construction, manufacture, commissioning, operation and decommissioning of the installations on the site including the preparation and review of safety documentation. 5. GUIDANCE ON ARRANGEMENTS FOR LC Safety Assessment Principle SAP MS.1 recognises that good leadership is key to achieving high levels of safety and establishing and sustaining a positive safety culture. The licensee s arrangements are expected to identify (by post or position in the organisation) an individual reporting directly to senior management with specific responsibility and authority for coordinating the development and implementation of the management system, and its assessment and continual improvement. The way in which this responsibility is discharged should be clear and visible. 5.2 European Nuclear Safety Directive 2009/71/EURATOM of 25 June 2009, Article 6 (4) requires member states to ensure that the national framework in place requires licence holders to establish and implement management systems which give due priority to nuclear safety. LC 17 transposes this requirement in the UK. 5.3 Inspectors should confirm that the licensee s quality management arrangements are based on current national or international quality management system standards and that the arrangements adequately address all matters which may affect safety. ONR considers IAEA Safety Standard No GS-R-3 (The Management System for Facilities and Activities) and associated Safety Guides GS-G-3.1 (Application of the Management System for Facilities and Activities) and GS-G-3.5 (The Management System for Nuclear Installations) to be relevant good practice, and a Licensee should be able to show that it either uses this standard or that its arrangements meet the expectations of the standard. A licensee may choose to use other standards such as ISO 9001 (Quality Management Systems Requirements). However, the principal purpose of ISO 9001 is to enhance customer satisfaction and if it is selected as the basis of the quality management arrangements it will be more difficult for the licensee to demonstrate how it is applied to all matters which may affect safety Licensees may choose to use an integrated management system. This approach is a requirement of GS-R-3 and is encouraged by ONR as it ensures safety is considered in all the licensee s activities and is not confined to the quality/safety management system. It also promotes a more consistent approach to treatment of other areas such as environment, security, transport and safeguards, and other business activities, and reduces the likelihood of incompatible arrangements. 5.5 Where applicable, Inspectors should be aware of the level of involvement of the licensee s corporate centre in developing the LC 17 arrangements and its role in the independent assessment and review processes. If the corporate centre provides any generic model procedures, Inspectors should be satisfied with these models and should ensure that the licensee s procedures are consistent with them or that any deviations from them are justified. 1 In this guidance nuclear safety has been abbreviated to safety unless otherwise stated. This is consistent with the approach taken in ONR s safety assessment principles and IAEA safety standards Page 3 of 11

4 6. GUIDANCE ON INSPECTION OF ARRANGEMENTS 6.1 This Section provides guidance to support the inspection of a licensee s LC 17 arrangements. It also gives guidance on what evidence the Inspector should seek to confirm the arrangements are working effectively. 6.2 LC 17 (1) requires licensees to establish and implement management systems which give due priority to safety. The licensee must therefore ensure that any of its management system(s) processes (e.g. financial, commercial, project, industrial safety or environmental) give due priority to safety. Inspectors may monitor this during their routine inspections by looking at the outputs from the management system processes to identify any instances where safety was adversely affected by actions or decisions which did not give due priority to safety (e.g. a purchasing decision for a safety significant item was based on cost rather than on fulfilling safety requirements). 6.3 Quality Management Arrangements -LC 17 (2) requires licensees to make and implement adequate quality management arrangements in respect of all matters which may affect safety. ONR expects such quality management arrangements to include the topics listed below in paragraphs 5.4 to Scope of the Quality Management System The scope of the arrangements should cover all matters which may affect safety including activities both on and off the licensed site. Inspectors should note that each facility on the site may be in a different phase in its lifecycle (e.g. research and development, siting, design, construction, commissioning, operation, or decommissioning) and should ensure that the licensee s arrangements cover all the applicable lifecycle phases. A licensee should review, and where appropriate revise, its arrangements before entering a new lifecycle phase. Inspectors should ensure that the processes identified by the licensee in the management system documentation are consistent with the current lifecycle phase(s) and that safety related activities are being controlled by the management system. 6.5 Site Licence Condition Compliance Processes The LC 17 arrangements should include all the processes which ensure compliance with the site licence conditions, including the arrangements which are made under specific licence conditions. Inspectors should ensure that the licensee is able to demonstrate compliance (e.g. by having a site licence condition compliance document that signposts the processes, procedures and instructions that deliver licence compliance). 6.6 Response to a Direction, Specification or Notification from the Executive The arrangements should clearly identify the process and person responsible for responding to a direction, specification or notification from the ONR, on behalf of the Executive, and how the constraints, caveats, actions or conditions imposed by the Executive are implemented. 6.7 Derived Powers Inspectors should ensure that any derived powers which have been agreed with the licensee are included in the arrangements. 6.8 Documentation of the Management System Inspectors should examine the management system documentation (e.g. management system manual) associated with the LC 17 arrangements and ensure it contains the following: i. A policy which includes a statement on quality (this may be a quality policy or in integrated management systems it may be contained in other policies such as the safety policy). The quality statement should be developed by senior management and be appropriate to the activities and facilities of the licensee. It should: Page 4 of 11

5 ii. iii. iv. NOT PROTECTIVELY MARKED be appropriate to the purpose and the activities of the organization. include a commitment to comply with management system requirements and to seek continual improvement (the management system standard(s) used by the licensee should be stated); support leaders in the development of a strong safety culture; reflect relevant statutory requirements (e.g. LC 17 to make and implement quality management arrangements in all matters which may affect safety); commit management to providing adequate financial, material and human resources; provide an appropriate framework for action and for establishing and reviewing goals and objectives; be reviewed periodically for continuing suitability and applicability; be effectively communicated, understood and followed within the organisation. An accurate description of the management system and its scope. An accurate description of the current structure of the organisation that falls within the scope of the LC 17 arrangements. This may be in the form of organisation charts and/or reference to the nuclear safety baseline document (see T/AST/065). Where necessary, the Inspector should seek advice from specialist Inspector colleagues to seek confidence that the organisation structure is as described and that arrangements are in place to actively manage and sustain an adequate organisational capability. A description of the functional responsibilities, accountabilities, levels of authority and interactions of those managing, performing and assessing work. The description should be in an easily readable format and should not rely on individual post profiles or job descriptions. This should include the senior manager responsible for the quality management system. It should also describe interface arrangements with external stakeholders. Some or all of this information may be contained in a safety management prospectus. T/AST/072 Function and Content of a Safety Management Prospectus provides more guidance on this document. v. A description of the processes and supporting information that explain how work is to be prepared, reviewed, carried out, recorded, assessed and improved. This may be in the form of process maps or diagrams. Lower level processes may be described in procedures. The licensee may divide its processes into categories (e.g. core, support and management). 6.9 A Graded Approach The licensee should consider the safety significance of its activities and grade the application of the management system so appropriate resources and control measures are deployed. When determining the level of control the licensee should consider the risk to safety and the complexity of the task. Examples of processes where the graded approach can be applied are: operations, maintenance, procurement, modifications, event investigation and decommissioning. Inspectors should determine how effectively the licensee evaluates such risks and if the management system controls are adequate. Work activities should be sampled to ensure that appropriate controls have been implemented. Page 5 of 11

6 6.10 Management Commitment The arrangements should require managers at all levels to demonstrate commitment to the management system and allocate adequate resources. Senior managers should develop values and behavioural expectations, and act as role models in their promulgation. Managers should communicate the need to adopt these values and expectations and to comply with the requirements of the management system. Inspectors may draw upon knowledge of the site to help judge if managers are meeting these requirements and if the management commitment and expectations are understood by all levels in the organisation. Technical Assessment Guide T/AST/078 Leadership and Management for Safety, which is currently draft for internal use only, provides further guidance Resource Management The arrangements should require senior management to determine and provide the resources necessary to carry out the activities of the licensee. Resources include individuals, infrastructure, the working environment, information and knowledge, and suppliers, as well as material and financial resources. Senior management should ensure competence requirements are established and that individuals are competent to perform their assigned work and understand the consequences for safety of their activities. Further guidance is given to Inspectors in T/AST/027 - Training and Assuring Personnel Competence and T/AST/048 - Management of Organisational Change Developing and Managing Processes A process approach should be adopted for the LC 17 arrangements and the licensee should identify and manage the processes needed for site licence compliance and other processes which may affect safety. An individual should be given responsibility for managing, improving and monitoring each process. Acceptable standards of work should be defined and any activities for inspection, testing, verification and validation, their acceptance criteria and the responsibilities for carrying out these activities should be specified. The work performed should be carried out under controlled conditions, using approved current procedures, instructions, drawings or other appropriate means that are periodically reviewed to ensure their adequacy and effectiveness. Inspectors should ensure the licensee is following this approach as it is a principle on which the management system standards are based Control of Measuring and Test Equipment Where measuring or test equipment is used for any inspection, testing, verification and validation activity which may affect safety, the equipment should be of the proper range, type, accuracy and precision. A process should ensure the measuring and test equipment is calibrated and traceable to national standards. Using a UKAS accredited calibration service is one method of achieving traceability. Inspectors should check the calibration process is applied to all measuring equipment which may affect safety (e.g. radiological measuring equipment, operational process measuring equipment and measuring equipment used for maintenance). Inspectors should check that equipment is uniquely identified and within its calibration period. Out of date equipment should be identified and segregated to prevent inadvertent use. The licensee should assess the validity of the previous measuring results when the equipment is found to be out of calibration (this may mean keeping a record of use of the equipment) Generic Management System Processes The Inspector should check that the LC17 arrangements contain the following processes. (Note these generic processes are requirements in IAEA Safety Standard GS-R-3). i. Control of Documents The document control process should describe how documents are written; the format and numbering system used; the methods and responsibilities for review and approval; and the method of distribution. The arrangements should ensure that current documents are available at the point of use and superseded documents are withdrawn. Documents may be in electronic Page 6 of 11

7 ii. iii. iv. NOT PROTECTIVELY MARKED format. Inspectors should sample documents to ensure they are in the correct format and have been reviewed and approved correctly. Work areas may be visited to see if documents are at the correct issue and if superseded or obsolete documents have been withdrawn. Inspectors should also look for any notices, aide memoires or note books which may constitute unauthorised and unapproved instructions. Control of Approved Arrangements should be included in the document control process. A documented process should control the revision and amendment of any arrangements that have been approved by the Executive. The process should ensure that no alterations or amendments are made without the approval of the Executive. The person(s) responsible for this process should be identified. It is good practice for approved documents to be clearly identified so as to prevent unintended amendment. Inspectors should check if the people writing, approving, revising or controlling approved documents are aware of the process. Approved documents may be sampled to ensure there have been no alterations or amendments have been made since the date of approval. Control of Products The licensee may have documented processes which control the manufacture and inspection of its products. Such processes are within the scope of LC 17 arrangements when they may affect safety. Inspectors should also be aware that incorrectly manufactured products may give rise to hazards when they are put into use (e.g. fuel pellets) and if product safety is found to be compromised Inspectors should take appropriate action. Control of Records Technical Assessment Guide T/AST/033 provides Inspectors with guidance when considering the management and control of records. v. Purchasing Technical Assessment Guide T/AST/077 provides Inspectors with guidance for assessing a licensee s procurement arrangements. Where appropriate (e.g. for safety related structures, systems and components) the licensee s procurement arrangements should require a supplier to be certificated to ISO 9001 by an accredited certification body or have its management system assessed in some other way to give confidence that requirements in the purchase specification will be fulfilled. vi. Communication The licensee s should have a process to communicate safety, health, environmental, security, quality and economic goals to all relevant personnel on site. vii. Management of Organisational Change - Technical Inspection Guide T/AST/048 Management of Organisational Change provides Inspectors with guidance on inspecting the management of change process Self Assessment A documented process should require management at all levels to carry out self assessment to evaluate the performance of work and the status of safety culture. The process should include recording the results of self assessment and the corrective actions taken. Inspectors should note that self-assessment is a requirement in GS-R-3 but there is no similar requirement in ISO Independent Assessment - The management system should contain a process for independent assessment. The GS-R-3 requirement for independent assessment is more onerous than the audit requirement in ISO 9001 and represents greater strength in depth. Page 7 of 11

8 It should be noted that a licensee s independent assessment arrangements may be made up of more than one process (e.g. audit and internal regulation). Outputs from the process should include: an independent assessment programme, assessment plans, assessment reports, corrective actions and opportunities for improvement. GS-R-3 states the purpose of independent assessment is: i. to evaluate the effectiveness of processes in meeting and fulfilling goals, strategies, plans and objectives; ii. to determine the adequacy of work performance and leadership; iii. to evaluate the organisation s safety culture; iv. to monitor product quality; v. to identify opportunities for improvement. vi. Various types of independent assessment can be used and these include: vii. Audit viii. Surveillance (of ongoing processes or work activities) ix. Inspection x. Peer review xi. Internal regulation xii. External audits and reviews The independent review process should be carried out by an organisational function which is sufficiently independent to ensure there is no conflict of interests and the arrangements should specify that individuals do not assess their own work. Inspectors should judge the effectiveness and scope of the independent assessment process, the adherence to the independent assessment programme and the quality of corrective actions Management Review A process should require senior management to carry out, at planned intervals, a review of the management system to ensure its continuing suitability and effectiveness. The inputs to the management review should include: outputs from all forms of assessment, the licensee s safety performance, non-conformances and corrective and preventative actions, lessons learned from other organisations, and opportunities for improvement. The process should describe how the outputs and actions from management review are managed and recorded. The management review should be documented and records kept as required by LC 6. Inspectors should check the licensee s records to ensure that management review is being carried out at planned intervals (at least annually). The Inspector should ensure that the outputs and actions from the review are effective in promoting the continual improvement of the management system and an improvement in safety culture Non-Conformances, Preventative and Corrective Action The arrangements should enable the identification, segregation, control, recording and reporting of non-conformances against processes, procedures or specifications. The impact on safety should be evaluated and corrective action taken to eliminate the cause of non-conformances. The arrangements should also include preventative actions to eliminate the cause of potential non-conformances. Where concessions are granted to accept non-conformances the Inspector should ensure the process includes a procedure for the acceptance and approval of concessions, this should include reference to the LC 20 or 22 processes where appropriate. The process should include the review of the status and effectiveness of Page 8 of 11

9 corrective and preventative actions. Corrective actions should be tracked to completion and performance indicators showing the status of actions should be available to the senior management. The Inspector should check that corrective actions are adequately verified before being signed off as complete. If the target completion dates are regularly extended it may indicate poor management of corrective actions. 7. GUIDANCE ON INSPECTION OF IMPLEMENTATION OF ARRANGEMENTS 7.1 ONR expects the licensee s LC 17 arrangements to address the site licence conditions and the requirements specified in national or international quality management system standards. The arrangements are therefore extensive and Inspectors must consider those areas which warrant attention, and the depth to which the inspection is carried out. Inspections should be informed by the safety case to identify areas of safety significance and factors such as lifecycle phase, organisational change, process change, projects, learning from events or defects should be considered when choosing which areas to sample. 7.2 A full LC 17 compliance inspection which looks at all aspects of the LC 17 arrangements will require a team of Inspectors and a number of days depending on the size and nature of the licensee s business. Inspectors should consider seeking advice from a Quality Management Specialist Inspector before planning such an inspection. 7.3 Typically, the Inspector will carry out a more targeted inspection of a licensee s arrangements, identifying the areas to be addressed by drawing upon factors such as risk, hazard, organisational change, events, intelligence, lifecycle, learning from experience, and other priorities determined as part of the intervention plan for each licensee-facing programme. Many areas may be sampled by Site Inspector(s) while carrying out other routine activities and compliance inspections. 7.4 Some parts of the LC 17 arrangements, listed below, are not generally covered during compliance inspections which are carried out against other licence conditions. These areas should therefore be considered as candidates for inspection during a specific LC 17 compliance inspection. i. Quality management system standard used by licensee ii. Response to specifications from the Executive; iii. Scope of the arrangements; iv. Documentation of the management system v. Developing and managing processes (overview); vi. Self assessment and independent assessment; vii. Management review; viii. Control of measuring and test equipment (process); ix. Control of documents (process) x. Procurement 7.5 When looking at the implementation of the quality management arrangements Inspectors should determine if the processes within the quality management system effectively deliver the intended outputs and high standards of safety. To achieve this Inspectors should first of all review the process documentation to ensure it clearly describes a process that will achieve the desired results. Where appropriate the Inspector should then observe work Page 9 of 11

10 activities and talk to the personnel carrying out the work rather than relying solely on paperwork or records to provide evidence of compliance. For example, Inspectors may attend a management review meeting as an observer or shadow one of the licensee s internal audits. 8. OTHER SOURCES OF INFORMATION 8.1 IAEA Safety Standard GSR-3 - The Management System for Facilities and Activities - Safety Requirements IAEA Safety Standard GS-R Application of the Management System for Facilities and Activities - Safety Guide IAEA Safety Standard GS-G The Management System for Technical Services in Radiation Safety - Safety Guide 8.4 IAEA Safety Standard GS-G The Management System for the Processing, Handling and Storage of Radioactive Waste - Safety Guide 8.5 IAEA Safety Standard GS-G The Management System for the Disposal of Radioactive Waste Safety Guide 8.6 IAEA Safety Standard GS-G The Management System for Nuclear Installations - Safety Guide BS EN ISO 9001:2008, Quality Management Systems Requirements 8.8 BS EN ISO 9000: Quality management systems Fundamentals and vocabulary 8.9 HSG65 (2 nd Edition 1997) Successful Health & Safety Management. ISBN BS OHSAS 18001:2007, Occupational Health and Safety Management Systems Requirements 8.11 For sites that are certificated to BS EN ISO 9001:2008 the site Inspector may discuss the findings from third party audits with the licensee Technical Assessment Guide - T/AST/027 - Training and Assuring Personnel Competence 8.13 Technical Assessment Guide - T/AST/039 Managing for Safety 8.14 Technical Assessment Guide T/AST/033 Licensee Management of Records 8.15 Technical Assessment Guide - T/AST/048 - Management of Organisational Change 8.16 Technical Assessment Guide - T/AST/065 Function and Content of the Nuclear Baseline 8.17 Technical Assessment Guide - T/AST/072 Function and Content of a Safety Management Prospectus 8.18 Technical Assessment Guide T/AST/077 Procurement of Nuclear safety Related Items or Services 8.19 Technical Assessment Guide - T/AST/078 Leadership and Management for Safety, (currently draft for internal use only) Page 10 of 11

11 8.20 Technical Inspection Guide T/INS/006 - LC 6 Documents, Records, Authorities and Certificates Page 11 of 11

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