Permissioning inspection

Date issued:

2005-10-20

Review date:

2008-10-20

Open Government Status:

Fully Open

Approved By:

W Ascroft-Hutton

1  Purpose and scope

1.1  The purpose of this document is to set out in overview the policies, procedures, roles and responsibilities for managing the Permissioning Inspection Key Business Activity, (KBA). It is relevant to all inspectors who carry out permissioning activity.

1.2  Permissioning Inspection covers all the processes where NSD has to respond to duty holders who seek to start, continue or cease specified activities under the NI Act 1965 and other relevant statutory provisions and includes the:

• initial licensing of new sites, re-licensing when ownership changes and de-licensing;
• receipt, consideration and assessment of proposals to satisfy the conditions attached to a nuclear site licence, or to satisfy the arrangements made by licensees in compliance with licence conditions;
• issue, change or withdrawal of Consents, Approvals, Directions, Notifications, Specifications, Agreements or Acknowledgements issued under the conditions attached to a site licence or arrangements made under a licence - collectively known as licence instruments.

2  Policy

2.1  All permissioning inspection is carried out in line with the principles of the HSE Enforcement Policy and the Policy for Permissioning Regimes

2.2  Inspection is the core process of nuclear safety regulation and involves warranted inspectors making judgements based on an appropriate sample of evidence drawn from the examination of documents, information from discussions with licensee staff and/or their contractors and visual observations of plant, processes and procedures on site to observe the conduct of activities. The purpose of the inspection activity will determine the balance between these sources and the sequence in which evidence is collected.

2.3  The purpose of permissioning inspection is to judge whether an activity subject to permissioning controls can be allowed to start/continue.

2.4  Permissioning proposals are judged against the requirements of the Health and Safety at Work etc Act (HSW) 1974, relevant statutory provisions made under the Act and other relevant legislation. These judgements will be informed by NSD's Safety Assessment Principles, BMS Technical Inspection and Assessment Guides and other standards and relevant BMS procedures, to ensure that the proposals satisfy the requirements of all relevant legislation and that decisions are reached on a consistent basis.

2.5  When making regulatory decisions inspectors will make judgements based on:

• a sample of evidence appropriate to the hazards and perceived risks sufficient to make a sound judgement of the submission;
• the relevant law, the NSD Safety Assessment Principles, Technical Inspection and Assessment Guides and other standards and BMS procedures;
• a constructive dialogue with licensees, to resolve areas of uncertainty before coming to a decision - though recognising that:
• in some circumstances provisional or staged decisions may be necessary; and,
• the quality of the decision-making process should not be compromised by the possibility that a regulatory decision may be delayed.

2.6  The output of the permissioning inspection process is a management decision of whether or not to grant permission based on the judgements of individual inspectors in regard to the adequacy of the proposals made by the duty holder/licensee.

2.7  Permissioning inspection informs future interventions including compliance inspection by identifying:

• specific issues which need to be followed up and checked subsequent to the granting of permission;
• critical aspects of a permissioning decision which should be included in future compliance inspection plans - whether or not it was a specific issue which was followed up;
• weaknesses in the licensee's capability (i.e. individuals or processes) to make suitable and sufficient permissioning proposals.

3  Roles and responsibilities

3.1  The Corporate Assessment Liaison Committee, (CALM), and the Inspection Coordination Group, (ICG), are the joint owners of the Permissioning Inspection KBA. These groups have specific responsibilities set out in the Business Management Manual, (BMM), and in Annex 7 of the BMM.

3.2  Heads of Division are responsible for:

• Allocating resources to permissioning inspection consistent with NSD strategic priorities and in proportion to the regulatory needs of the range of organisations, activities and sites within their Division.
• Ensuring the production of proportionate targeted permissioning inspection plans for each organisation and site in the Division, monitoring implementation and reporting on performance.
• Leading contact with duty holders allocated to their Division.
• Signing consent, approval and direction licence instruments.

3.3  Nuclear Topic Leaders, (NTLs), will act as the focus for consistency of regulatory application, provision and co-ordination of operational advice, adequacy of standards and guidance, and advice on research, training & development and resources, for their nominated specialist topic area.

3.4  Unit Heads, within in the permissioning KBA: manage their team to maximise regulatory impact; co-ordinate the production of proportionate, targeted permissioning inspection reports etc for their Unit; monitor consistency and quality of the work; perform the nuclear safety challenge function; sign licence instruments where appropriate; follow up the resolution of specific issues arising from permissioning decisions and report on performance. They generally, take responsibility for coordinating regulatory interaction with licensees/duty holders at corporate level.

3.5  Inspectors undertake permissioning activities in a proportionate, consistent, transparent and targeted manner in accordance with plans of work agreed with their Unit Heads and sign licence and other legal instruments where appropriate. Inspectors' plans of work should accord with timescales agreed with line managers taking account of emerging matters of greater safety significance or potential worker or public concern.

3.6  The supporting BMS procedures to this KBA set out other roles and responsibilities for managers, inspectors and other staff

4  Definitions

4.1  HSC / E - Health and Safety Commission / Executive

4.2  NSD - Nuclear Safety Directorate

4.3  NII - Nuclear Installations Inspectorate

4.4  ICG - Inspection Co-ordination Group

4.5  Assessor - an inspector whose main role is to undertake permissioning inspection, principally through assessment.

4.6  Site inspector - an inspector nominated to lead and coordinate NSDs regulatory contact, with a particular site, part of a site or a number of sites.

4.7  Project Inspector - in this procedure refers to Regulatory Project Officers whose work includes the following agreed in MB paper MB/05/13:

• Large scale/lengthy timeline modifications
• PSRs
• Whole site or licensee intervention work e.g. improving the quality of safety submissions
• Organising/leading team inspections
• EIDAR projects and QQR's
• Emergency Response capability covering all sites
• Security informed nuclear safety across all sites

4.8  Assessment - applying specialist expertise and judgement to permissioning and compliance inspection as required to achieve NSD's mission.

4.9  Discretion - the freedom of those authorised to make appropriate informed judgements and decisions in a fair and reasonable manner, within the scope of their powers and responsibilities, and within the latitude established by the law, and the supporting principles, standards and good practice examples set out in the BMS. The guidance given in G/AST/001 is relevant to the exercise of discretion when carrying out assessment.

4.10  Duty holder - the body corporate with duties under the HSW 1974 Act which is regulated by NSD and which makes permissioning submissions.

4.11  Issue - a finding, concern or point of variance with the licensee, identified during the permissioning process, which is considered important to safety and which requires action by the duty holder in order to satisfy the tests of adequacy or compliance in relation to a permissioning decision.

4.12  Submission - means a formal request for permission under the requirements of a nuclear site licence.

5  Procedures

5.1  The attached table summarises the key steps in the permissioning KBA and references other supporting BMS procedures that provide detail of the process steps where appropriate.

6  Associated documents

• 6.1 AST/001 - Assessment Process
• 6.2 AST/002 - Assessment Activity Management
• 6.3 AST/003 - Assessment Reports
• 6.4 AST/004 - Issues Recording Process
• 6.5 BMM/ANNEX/006 - Nuclear Topic Leads and Groups and Nominated Specialists

7  Permissioning procedure summary

7.1  All the following procedural steps that involve consultation and liaison with NSD licensee/duty holders are to be carried out within a framework of established arrangements. These include: MoU's with other regulators and agreements on Working together on Nuclear Sites.

	Process steps	Information and records for control and management
1	Preparation and planning for receipt of submissions (anticipating demands)
1.1	Inspectors, under the guidance and coordination of Unit heads maintain contact with licensee/duty holders to acquire knowledge of their plans and likely need for permissioning. Unit heads use this information as part of planning e.g. via the Regulatory Review Meetings forming part of NSD's Integrated Intervention Strategy (IIS), process. Unit heads and DCIs decide on need for Project inspectors where submissions are likely to be large, complex and/or cover cross-site issues.	Information on the likely number, nature and timescales of submissions anticipated. Specific information on those, which are 'required' by regulatory need, e.g. Periodic Safety Reviews and other time bound permissions.
1.2	Inspectors, with support from admin teams where appropriate, monitor receipt of safety submissions 'required' from licensee/duty holder to ensure they are delivered on time, EMM principles applied to late or potentially late submissions.	List of 'overdue' safety submissions with reasons for delay and records of EMM decisions and suitable bring forward arrangements to monitor progress.
1.3	Where appropriate to facilitate cost effective permissioning, inspectors may engage with licensee/duty holder at an early stage to influence, consider and comment on early thinking and optioneering by the licensee for new projects etc prior to receipt of formal submission.	Note of nature of contacts and advice given.
2	Submission documentation received
2.1.	Documentation logged in by administrative staff. For routine safety case submissions, a check of completeness may be conducted to ensure that a covering letter, safety case, INSA and safety committee report are included. Inspectors judge whether to proceed with incomplete submissions depending on the scale, nature of the submission, confidence in licensee, track record and competence of licensee and the timescales involved.	Date of receipt of each 'submission'. In cases where it is decided not to proceed, records describing the basis for this decision.
2.2	Inspectors conduct an initial review and screening of submission for completeness and adequacy relative to current expectations - see T/AST/051 . . Inspectors take action in line with EMM principles (INS/30) for inadequate submissions.	Record of the outcome of initial review. Records of the number and quality of submissions as a basis regulatory action and performance history of each licensee.
2.3	Inspectors decide on the scope (breadth), nature, (technical issues/aspects to address), and depth of any assessment required in consultation with relevant colleagues and in line with current policies: i.e. all submissions made in compliance with primary powers, (required by licence conditions) will be assessed; all "Category 1" or equivalent modifications and other submissions will be assessed proportionately taking account of: The safety significance of the issues covered in the submission - including any strategic priorities for attention; The complexity of the submission; The degree, nature and novelty of change proposed; History and condition of site facilities and licensees management performance; Ensure that resources are prioritised and allocated. Unit heads supervise and monitor assessment request decisions to: ensure discretion is exercised appropriately; ensure appropriate areas/aspects of the submission are nominated for assessment; and; be informed of the nature of future; permissioning decisions that will be required; ensure that attention is given to areas of greatest regulatory importance.	ARFs (see AST/002) Numbers of: Assessment requests sent to assessment Units for action, (irrespective of whether an ARF is raised); and Submissions retained for action by site inspector
2.4	Assessment resource secured by inspectors handling submission.   Inspectors initiate the assessment work, in consultation with potential relevant assessor(s) and Unit head if necessary and agree the formal assessment documentation. Initiator of assessment, (site/project inspector) should discuss scope and nature of proposed work with relevant assessor(s) in advance of submitting formal request for work using ARF form. (See AST/001 & G/AST/001 for assessment process overview; AST/002 & G/AST/002 for details of ARF system and AST/003 & G/AST/003 for details of assessment reporting requirements).	Completion of ARF documentation for those jobs involving more than half a day.
3	Assessing submissions in Assessment Units
3.1	Assessment work is planned, completed and managed, (See AST/001 & G/AST/001 for assessment process details and AST/002 & G/AST/002 for details of ARF system).   Assessment Unit Heads decide whether to accept the work. If accepted the Unit head allocates work to the assessor and monitors the progress of work through the use of the ARF system. Individual assessors are responsible for scheduling and planning their own work and liaising with other assessment colleagues in other disciplines and the duty holder where timescales may exceed the duty holder expectations. The scope of assessor tasks includes: ensuring that there is an ARF for all tasks (except those specifically excluded) and that the agreed scope of work and other relevant data, as required, is recorded in the ARF Database; planning and undertaking any allocated assessment task to the required standard, exercising discretion in the selection of an appropriate part or sample of the submission for detailed study, and for keeping an appropriate record of the work undertaken; keeping the ARF originator and Unit Head informed of progress, seeking to clear assessment findings and for ensuring that there is a formal record of how findings and issues have been resolved. (Issues unresolved before permissioning decisions are recorded - see step 3.2); initiating appropriate action in line with the EMM where serious deficiencies are discovered during the assessment process; ensuring that the entries on the ARF database are kept up to date; performing the assessment and producing an auditable trail, in line with the task specification, recording the assessment and the basis upon which any conclusions and recommendations are reached. Consultations with EA/SEPA or other enforcing authority is carried out in line with MoUs.	Numbers of ARFs in progress and current position. Number of assessment requests not in ARF system and progress EMM decisions and actions should be recorded on relevant files
3.2	Assessors report in a suitable form in line with requirements set out in BMS/AST/003 & G/AST/003 , providing clear unambiguous regulatory advice.   Assessment Unit heads: provide a challenge function to test the robustness of decisions in assessment reports, whether or not licensee proposals are supported; ensure that the output is in the correct form, adequately addresses the request of the ARF originator and that a suitable auditable trail has been produced to show how decisions were made; formally accepts (or otherwise) the assessment advice on behalf of NSD.   Assessors feed forward information and intelligence from assessment that should inform future interventions, including compliance inspections.Assessors raise issues not resolved during the course of assessment in line with BMS/AST/004 . This includes: ensuring that the issue and the record of how it has been dealt with are properly recorded on the appropriate file; entering it onto the NSD Issues Database as the originator of the Issue; taking ownership of the issue or, where appropriate, arranging for another NSD inspector to take ownership. The owner of an issue is responsible for: ensuring that it is resolved and closed out, and that this is recorded on the NSD Issues Database; when changing posts, to continue with the ownership of the Issue, or to transfer the ownership to the new post holder or another NSD staff member.  Assessment Unit heads monitor to ensure that, within their Unit, the guidance for determining the status of issues is consistently applied, that Issues are entered on the Issues database and that Issues are being closed out in a timely manner.	Suitable records are maintained by assessors to provide an auditable trail in line with the Document Management System (DMS) requirements. The ARF database is completed. Information in a form that can be used to inform interventions is recorded. Numbers and safety significance of issues outstanding for attention and progress to monitor if 'backlog' is growing or declining.
4	Making & recording permissioning decision
4.1	The inspector initiating the work collects assessor comments and recommendations and compile a Project Assessment Report, (PAR), to advise on the licence instrument decision. See BMS/INS/001 for process details. Where solely site/project inspectors have assessed submissions the Unit Head should review the PAR and decide if the issues involved are of such significance that peer review is warranted, by other colleagues or the appropriate NTL, before clearance.   Inspection Unit heads, (or Band 2 inspectors for de-fuelled reactor sites), make final permissioning decisions in line with the principles of the EMM . Differences in opinion between inspectors on how assessment recommendations should impact on permissioning decisions should be raised and resolved using the process in BMS/INS/031 .	Records supporting the issue of licence instruments placed on DMS. Fraction of permissioning requests: a) Fully agreed; b) Partially agreed (e.g. with caveats), c) Rejected. Numbers of Consents, Approvals and Agreements issued to time used as OPM - see BMS/INS/001Number of occasions the BMS/INS/031 process is needed to resolve differences of opinion.
4.2	Issue of licence instrument and communication of decision.	Numbers and type of licence instruments issued and information on numbers of any other actions closing out submissions.
5	Learning from experience
5.1	Appeals by licensees against permissioning decisions and challenges are dealt with through BMS procedures BMS in preparation.	Numbers of appeals received, fraction upheld and details of close out and resolution and lessons learned.
5.2	Case reviews for the benefits of learning are conducted when any person involved in a case proposes a review, and this is agreed by the appropriate Unit head. Criteria for proposing a case review include: The task was complex and multi-disciplinary. The task significantly exceeded the estimated effort. There were significant issues when interacting with the licensee. 3a. There were significant issues interacting internally. There were differences in professional opinion between inspectors and procedure BMS/INS/031 was invoked. The permissioning decision was contrary to that recommended by the assessment process. Issues have arisen which may have wider regulatory implications. Case reviews involve: Objective examination by those not directly involved in the case, in a reasonable time after the resolution of the case, but with sufficient time for reflection. Looking at the way the job was done rather than at the technical issues (other than to the extent which these impinge on the effectiveness of the process followed). Encouraging openness and emphasising the opportunities for learning. Allowing all participants the time to share their perceptions and any concerns. Only look back because this might provide opportunities for future improvements. Clarifying the key lessons and resulting in an action plan to implement any improvements. Active management oversight to ensure recommendations from any action plan are addressed in a timely manner.	Numbers of reviews and lessons learned.