T/INS/019 - Issue 2
1.1 The purpose of this guidance is to facilitate a consistent approach to LC 19 compliance inspection and to provide assistance to inspectors while carrying out their duties in this area. The guidance should not be regarded as mandatory. Although every attempt has been made to deal with all the key features which are likely to arise in inspecting for compliance against this licence condition additional aspects may need to be examined to ensure a comprehensive and complete inspection.
1.2 The guidance does not indicate when or to what extent these compliance inspections should be made as these matters are covered in individual inspectors’ inspection programmes.
1.3 The guidance provided is split into four main elements:
19(1) Where the licensee proposes to construct or install any new plant which may affect safety the licensee shall make and implement adequate arrangements to control the construction or installation.
19(2) The licensee shall submit to the Executive for approval such part or parts of the aforesaid arrangements as the Executive may specify.
19(3) The licensee shall ensure that once approved no alteration or amendment is made to the approved arrangements unless the Executive has approved such alteration or amendment.
19(4) The aforesaid arrangements shall where appropriate divide the construction or installation into stages. Where the Executive so specifies the licensee shall not commence nor thereafter proceed from one stage to the next of the construction or installation without the consent of the Executive. The arrangements shall include a requirement for the provision of adequate documentation to justify the safety of the proposed construction or installation and shall where appropriate provide for the submission of this documentation to the Executive.
19(5) The licensee shall, if so directed by the Executive, halt the construction or installation of a plant and the licensee shall not recommence such construction or installation without the consent of the Executive.
3.1 This Licence Condition is part of the group of conditions (LCs 19 -22 & 35) designed to provide a system of rigorous and appropriate regulatory control of changes to plant or processes on the licensed site. These changes may be brought about by construction, modification or commissioning of new plant, commissioning, modification or experiment on existing plant including any change of process, and decommissioning. The purpose of this Condition is to ensure that adequate arrangements exist for the construction or installation of new plant which may affect safety
3.2 The term new plant here means essentially, a development separate from an existing facility; however it should be noted that new ‘separate’ plant could be installed within the existing envelope of the facility. The regulation of the linkages that may affect safety between a new and an existing facility requires the licensee to clearly identify and define ownership and responsibilities.
3.3 Changes to the design of plant under construction shall be progressed under arrangements made under LC 20.
3.4 Changes to an existing facility or process shall be progressed under arrangements made under LC 22 as appropriate.
3.3 Specific requirements for decommissioning including strategies and programmes shall be progressed under arrangements made under LC 35.
4.1 In addition to the general requirements for all Licence Conditions the licensee’s arrangements shall satisfy the specific Licence Condition requirement(s) for Licence Condition 19 which are:
5.1 The following list includes elements of good practice which have been compiled from information currently available. This list is neither exclusive or exhaustive and will be subject to review and revision in the light of operational experience. Good practice elements may exceed minimal compliance requirements.
5.2 If licensees have generic model(s) for arrangements then it is for the site to justify any deviation from the model(s). Site staff should be able to demonstrate how their arrangements meet the regulatory requirements. [Note: not all licensees use generic models].
5.3 Arrangements shall address the licence condition requirements
5.4 Arrangements should include a system for classification by safety significance of new plant or installation based on hazard which takes due recognition of the works being inadequately conceived or executed and should include a review process for each classification commensurate with safety significance i.e.robust review/assessment for the most significant safety classification and referral to the relevant safety committee or Nuclear Safety Committee as appropriate. Arrangements should be specific about assuming the worst that can happen, i.e. inadequately conceived or executed, without reference to risk. The use of a risk based classification system frequently results in lower categories being applied; however, the risk assumption used offers the potential for inadequate conception. Good practice classification systems have categories linked to potential doses to members of the public and workers on the site. In addition where there is the potential for significant off site doses (e.g. doses in excess of 5mSv for members of the public) or where dose limits for workers on the site could be exceeded. such proposals should be referred to NII as well as clearing the licensee’s own due process.
5.5 The classification system for safety significance should be consistent with that used for LC20, 21, 22 and 35.
5.6 Arrangements should allow ONR to agree or acknowledge and opt in or out of regulatory hold points as appropriate (flexibility for NII permissioning activities).
5.7 Arrangements should include a requirement for construction or installation of new plant proposals to be systematically compiled, reviewed, assessed, revised, extended, validated, verified, approved or cancelled by staff who are SQEP/DAP. This should include as a minimum multiple agreement, separate assessment and independent authorisations prior to implementation. Where appropriate independent company safety departments and expert staff should also confirm satisfaction with the proposal.
5.8 Arrangements should identify the requirements for the licensee’s construction/installation programme(s) to include adequate time for assessment of safety submissions by ONR and or other regulators. This time should be independent of that required for their own internal peer review processes, which should be complete before submission to the regulators.
5.9 A procedure should be in place for recording, tracking and progressing modifications (LC 20), technical queries, concessions and omissions for all construction and installation works.
5.10 Arrangements should require an implementation Quality Plan or similar scheme for construction/installation activities which addresses:
5.11 Arrangements should demonstrate the linkage to the facility’s safety case and its development in line with design, construction or installation activity.
5.12 Arrangements should require that there is a clear linkage to other supporting arrangements e.g. LC 14 Safety Documentation, LC 20 Modifications to Design of Plant Under Construction, LC24 Operating Instructions and LC28 Examination, Inspection Maintenance and Testing.
5.13 Arrangements should allow for the Executive to achieve regulation of projects using the secondary powers provided under the licensee’s arrangements, i.e. the release of agreed programme holdpoints should be via licence instruments apart from, for example, use of the primary power associated with the formal Consent to Operate a facility.
6.1 Inspectors are required to apply their experience and discretion to determine the extent and depth of a particular inspection taking due account of a number of factors such as safety significance, complexity, importance and technical specialism of the area. In some cases it may be possible for the inspector to reallocate progress of specific regulatory matters on a topic within his unit or division.
6.2 The following list of areas for inspection of arrangements for compliance with LC 19 has been compiled from best information available. This list is neither exclusive or exhaustive and will be subject to review and revision in light of operational experience.
6.3 Sample, check licensee’s safety classification system for construction or installation of new plant, challenge as necessary.
6.4 Sample, check the licensee’s control of implementation of construction/installation work, including,
6.5 Sample, check the application of the licensee’s safe system of work process for control of construction/installation hazards (conventional and nuclear). Inspectors should take account of the Memorandum of Understanding for the arrangements for conventional health and safety regulation on nuclear sites. The requirement of joint inspections with FOD should be considered.
6.6 Sample, check the application of the licensee’s system for progressing issues arising from design, construction or installation activities including the management of technical queries, concessions and omissions.
6.7 Sample, check that there are appropriate links to the safety case requirements for every stage of development of design, construction and installation and that those responsible for undertaking and implementing these activities are aware of/have access to the safety case requirements.
6.8 Sample, check time limits for completion of design, construction or installation activities and that there are no undue delays. Although delays are largely a commercial matter for the licensee, clearly there is a need for the inspector to ensure that this does not impact upon NII’s ability to assess any safety documentation in support of the release of any holdpoint. Additionally, undue delays should not adversely affect the ability of the licensee to deliver project milestones that may have been declared elsewhere, i.e. decommissioning programmes. Progress on some activities may be critical to the success of other projects. The knock-on effects of delays should be recognised by the licensee.
6.9 Sample, check example(s) of design, construction or installation activities that adequate progress has been made in key areas to enable, the facility or process to progress from one stage to the next. Areas to consider here include:
6.10 Where ONR Consent is required to proceed beyond a hold point, sample check that licensees due process has been completed in addition to the elements listed is 6.9 above.