ONR BMS: Permission inspection - Managing the permissioning inspection key business activity

PI/FWD - Issue 2

Issue date:: 23/11/2009
Review date:: 23/11/2012
Open Government Status:: Fully Open
Approved By:: Andy Hall

Purpose and scope
Policy
Roles and responsibilities
Definitions
Procedures
Associated documents
Permissioning procedure summary
Process steps

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 ONR responds to duty holders who seek to start, continue or cease specified activities under the NI Act 1965 (As amended) (NI Act) 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 [PDF] and the Policy for Permissioning Regimes [PDF]

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 objective of the inspection activity will determine the balance between these sources and the sequence in which evidence is collected to inform the permissioning decision.

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 HSE's Safety Assessment Principles, Technical Inspection and Assessment Guides and other standards and relevant 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:

Samples of evidence appropriate to the hazards and perceived risks sufficient to make a sound judgment of the submission;
Relevant law, the Safety Assessment Principles, Technical Inspection and Assessment Guides, other standards and BMS procedures;
Recognised good practice such as that from IAEA and that of other national regulators as well as relevant parts of high hazard industries;
Constructive dialogue with licensees, to resolve areas of uncertainty before coming to a decision recognising that:

in some circumstances provisional or staged decisions may be necessary; and,
the decision making process should not be compromised by time pressure subject to proportionality considerations.

2.6 The output of the permissioning process is a management decision of whether or not to grant permission based on professional judgements of inspectors about the adequacy of the submissions and the plant, processes and procedures that flow from such submissions.

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

Issues which need to be followed up and checked following permissioning;
The key aspects of the permissioning decision which should be included in future compliance inspection plans;
Weaknesses in the applicant’s capability (individuals, groups 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 consistent with strategic priorities and in proportion to the regulatory needs of the range of organisations, activities and sites both within their Division and across the Directorate. (see INS/008)
Ensuring the production of proportionate targeted plans for their allocated Divisional responsibilities, 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), act as the focus for consistency of regulatory application, provision and co-ordination of operational advice, adequacy of standards and guidance, advice on research, training & development and resources, for their nominated specialist topic area(s).

3.4 Unit Heads, manage their unit to maximise regulatory impact; co-ordinate the production of proportionate, targeted permissioning reports etc for their Unit; monitor consistency and quality of the work; perform the nuclear safety challenge function; sign licence instruments (BMM Annex 2) 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, accountable and targeted manner in accordance with plans of work (INS/008) and sign licence and other legal instruments where appropriate (BMM Annex 2). Inspectors' plans of work should accord with timescales agreed with line managers and relevant management group(s) taking account of emerging matters of greater safety significance or potential worker or public concern.

3.6 CALM is responsible for appointing suitable person(s) to be responsible for the review and audit of this document, and the associated systems.

3.7 The supporting procedures set out other roles and responsibilities.

4. Definitions

HSE - Health and Safety Executive

ONR - Office for Nuclear Regulation

NII - Nuclear Installations Inspectorate – the inspectorial part of ONR primarily concerned with enforcing the site licence.

CALM – Corporate Assessment Liaison Meeting

ICG - Inspection Co-ordination Group

EMM – HSE’s enforcement management model (see also INS/0030)

Allocated Inspector - the inspector whose main role is to undertake technical permissioning work;

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

Project Inspector - in this procedure refers to Regulatory Project Officers whose work includes coordinating the following:

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

Assessment - applying specialist expertise and judgment to permissioning and compliance inspection as required to achieve ONR's mission.

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 BMS. The guidance given in AST/001 is particularly relevant to the exercise of discretion.

Duty holder - the body corporate with duties under the HSW 1974 Act which is regulated by ONR and which makes permissioning submissions usually under the NI Act licensing.

Issue - a finding, concern or point of variance with the Duty Holder, identified during the regulatory process, which is considered important to safety and which requires action by the Licensee in order to satisfy the tests of adequacy or compliance in relation to a regulatory decision.

Submission - means a formal request for permission under nuclear site licence conditions.

Advice – opinion(s) given to a duty holder to help them comply with the law or their own arrangements. Such advice is given in good faith in the light of current knowledge and understanding but is not binding on either party.

Management Group – typically Intervention steering, management and progress groups formed in compliance with INS/008.

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 - Inspectorial Work Management

6.3 AST/003 - Technical Reporting

6.4 AST/004 - Issues Recording Process

6.5 BMM/ANNEX/006 - Nuclear Topic Leads and Groups and Nominated Specialists

7. Permissioning Procedure Summary

All the following procedural steps that involve consultation and liaison with ONR licensee/duty holders are to be carried out within a framework of established arrangements. These include: MoUs with other regulators and other relevant agreements

	Process Steps	Information and records for control and management
1. Preparation and planning for receipt of submissions
1.1	Inspectors - under the guidance and coordination of Unit heads maintain contact with licensees/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 ONR's Strategies. Management Groups decide on regulatory strategy and the 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 licensees/duty holder to ensure they are delivered on time, with the 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	To facilitate effective permissioning, inspectors may engage with licensee/duty holder at an early stage to advise on early thinking and optioneering prior to receipt of a submission.	Note of nature of contacts and advice given. E.g. Contact Report (INS/003)
2. Submission documentation received
2.1.	Documentation logged in by administrative staff. See BMS/BSS/CAN/001. For routine submissions, a check of completeness may be conducted to ensure that a covering letter, and other required documents are included. (T/INS/14 gives guidance) Project Inspectors - in consultation with relevant Unit Head(s) judge whether to proceed with incomplete submissions depending on the submission significance, confidence in and competence of the applicant and timescales.	Date of receipt of each 'submission' and TRIM. 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 and INS/001. Inspectors take action in line with EMM principles 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. (INS/008)
2.3	Inspectors decide on the scope, of work required in consultation with colleagues in line with current policies: submissions required for compliance licence conditions will be assessed; all top category modifications (Cat 1 or Cat A) submissions will be assessed proportionately: lower category modifications (Cat 2 or Cat B) may be assessed if ONR considers it appropriate. Unit Heads / Management Groups supervise and monitor work to: ensure discretion is exercised appropriately; ensure appropriate areas/aspects of the submission are nominated for assessment; be informed of the nature of future permissioning decisions that will be required; ensure that attention is given to areas of greatest regulatory importance: ensure that resources are prioritised and allocated.	COIN Cases (see AST/002)
2.4	Resource secured by inspectors handling submission. Inspectors initiate the work, in consultation with potential relevant colleague(s) and Unit head if necessary and agree the work. (see AST/001 for assessment process overview; AST/002 for details of work requests and AST/003 for details of technical reporting).	Update of COIN database for those jobs involving non trivial, effort (AST/002).
3. Assessing submissions in Assessment Units
3.1	Work is planned, completed and managed, (see AST/001 for process and AST/002 for COIN). Unit Heads decide whether to accept the work. If accepted the Unit head gives authorisation for the work to the allocated inspector and monitors the progress of work through the relevant intervention management group and the COIN database. Allocated Inspectors are responsible for scheduling and planning their own work and liaising with colleagues in other disciplines and the duty holder especially where timescales may exceed the duty holder expectations. Consultations with EA/SEPA or other enforcing authority is carried out in line with MoUs.	Numbers of Cases in progress and current position. EMM decisions and actions should be recorded in relevant reports (AST/003)
3.2	Allocated inspectors: Report in compliance with AST/003, providing regulatory advice. Feed forward information and intelligence to inform future interventions, including compliance inspections. Raise issues not resolved during the course of assessment in line with AST/004. Management groups monitor the status of issues including those entered on the ONR Issues database (COIN) and that Issues are being closed out in a timely manner.	Suitable records are maintained on TRIM to provide the Auditable Trail. The COIN 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 Originator collates report outputs and recommendations and compiles a Project Assessment Report, (PAR) (AST/003), to advise on the licence instrument decision. Unit Heads review the PAR and, where appropriate, initiate a peer review is carried out before acceptance. (AST/003) 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 recommendations should impact on permissioning decisions should be raised and resolved using the process in http://intranet/operational/nsd_bms/inspection/ins_031/index.htm	Records supporting the issue of licence instruments placed on TRIM.
4.2	Issue of licence instrument and communication of decision.(INS/001)	Numbers and type of licence instruments issued
5. Learning from experience
5.1	Appeals by licensees against permissioning decisions and challenges are dealt with through HSE procedures.	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 the work proposes a review, and it is agreed by the appropriate Unit Head. (This is not to be confused with a report peer review). Criteria for proposing a case review include: 1. The task was complex and multi-disciplinary. 2. The task significantly exceeded the estimated effort. 3. There were significant issues when interacting with the licensee. (ONR Issues – AST/004) 4. There were significant issues interacting internally. 5. There were differences in professional opinion between inspectors and procedure INS/031 was invoked. 6. The permissioning decision was contrary to that recommended by the work process. 7. Issues have arisen which may have wider regulatory implications. (AST/004) Case reviews involve: 1. 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. 2. 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). 3. Encouraging openness and emphasising the opportunities for learning. 4. Allowing all participants the time to share their perceptions and any concerns. 5. Looking back to identify opportunities for future improvements. 6. Clarifying the key lessons and resulting in an action plan to implement any improvements. 7. Active management oversight to ensure recommendations from any action plan are addressed in a timely manner to promulgate the learning.	Numbers of reviews and lessons learned.