Guidance: LC15 Periodic review
Site inspection and enforcement
T/INS/015 - Issue 1
1. Purpose and scope
1.1 The purpose of this guidance is to facilitate a consistent approach to LC 15 compliance inspection and to provide assistance to inspectors while carrying out their duties in this area. The guidance should not be regarded as either comprehensive or mandatory.
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:
1) Purpose of the Licence Condition
2) Guidance on arrangements for LC 15.
3) Guidance on inspection of arrangements.
4) Guidance on inspection of implementation of arrangements
2. Licence Condition
2.1 Licence Condition 15 - Periodic review
15(1) The licensee shall make and implement adequate arrangements for the periodic and systematic review and reassessment of safety cases.
15(2) The licensee shall submit to the Executive for approval such part or parts of the aforesaid arrangements as the Executive may specify .
15(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.
15(4) The licensee shall, if so directed by the Executive, carry out a review and reassessment of safety and submit a report of such review and reassessment to the Executive at such intervals, within such a period and for such of the matters or operations as may be specified in the direction.
3. Purpose of Licence Condition
3.1 This condition requires the Licensee to ensure that throughout its declared lifetime, the plant remains adequately safe and that the safety cases are kept up to date. Towards this end, the safety cases should be periodically reviewed in a systematic manner to meet the following objectives:
1) To review the current safety case for the plant and confirm that it is still adequate;
2) To compare the case against current standards for new plant, evaluate any deficiencies and implement any reasonably practicable improvements to enhance safety;
3) To identify ageing processes which may limit the life of the plant;
4) To revalidate the safety case until the next PSR, subject to the outcome of routine regulation.
3.2 The arrangements should include a programme specifying the periodicity of these reviews. Some aspects of these arrangements may be discussed and agreed with the Licensee by NSD at a corporate level. Where this is the case the arrangement at individual sites should reflect these agreements.
3.3 In addition, the arrangements should identify a system of reviews and reassessments of safety cases commensurate with the number and safely significance of modifications made to the plant. These reviews, which should be undertaken on a short term basis, should confirm that the safety case remains valid; that implications of all modifications have been addressed, and in addition, other matters such as incidents, have been taken into account. Reassessments should be undertaken on a longer term planned basis unless a review has indicated a need for a shorter or more immediate timescale. Such reassessments will involve the revision and re-issue of the safety case incorporating all the safety submissions made since the case was last issued.
3.4 LC15(1) provides for the making and implementation of arrangements for review of safety cases. It is these arrangements that can provide NII with secondary or derived powers in this area to control this process.
LC15(2) gives the power to the Executive to specify the arrangements or parts of arrangements for approval . This power would generally be used when these arrangements are first made, not for subsequent alterations. Specifications and approvals are rarely used for this LC.
LC15(3) ensures that where the Executive has approved arrangements, the Licensee must apply for approval to amend or alter these arrangements.
LC15(4) gives the power to the Executive to direct the Licensee to carry out a review of safety and submit a report at such intervals as we may specify . This clause provides the primary powers to ensure that the Licensee carries out periodic reviews at such intervals as we may specify. These powers are not generally used: most periodic review is regulated via derived powers under the Licensees arrangements.
4. Guidance on arrangements for LC 15.
4.1 The following list of elements of arrangements provide NSD's views on what the Licensee's arrangements might be expected contain to comply with the LC. The list is neither exclusive nor exhaustive and will be subject to review and revision in light of operational experience. If licensees have generic model(s) for arrangements then it is for the site to justify any deviation from the model(s). [note: not all licensees use generic models].
4.2 Arrangements should be provided to comply with LC 15.
4.3 Arrangements shall address the licence condition requirements.
4.4 Arrangements should be readily available and should be up to date, signed by an appropriate senior manager and controlled under a system compliant with the requirements of LC17.
4.5 The arrangements should identify, as appropriate, a tiered system of reviews and reassessments of safety cases with a corresponding level of detail for each tier. The arrangements may typically refer to three types of review and reassessments:
1) periodic shutdown reviews carried out at the time of a periodic shutdown of the plant, process or system and reported upon at start-up meetings. For some plants it would be appropriate for these reviews to be carried out annually without being associated with a periodic shutdown;
2) periodic safety reviews of plant, processes and systems which are carried out at regular intervals (no longer than 10 years). Each review of this type should include a reassessment of safety cases to re-examine the design assumptions and criteria for the plant, processes and systems in the light of past and projected future operations; and
3) "exceptional (or reactive) reviews" which have followed for example an event on or off the site, recognition of changes in known (or a new) degradation mechanism(s), adverse changes in methodology eg range of validity/ basic assumptions, etc, that may lead to the safety case to be questioned.
4.6 The arrangements should ensure that the routine reviews and reassessments include, as a minimum the following aspects:
1) operating experience since the last review;
2) maintenance, inspection and testing experience since the last review;
3) modifications to the plant since the last review;
4) the history of incidents and abnormal events since the last review;
5) worker doses;
6) the accumulation and monitoring of radioactive waste;
7) radiation and contamination levels in and around the plant;
8) changes in safety standards or safety methodology/ assumptions;
9) changes to and behaviour of life limiting items;
10) changes in management of safety standards and aspects affecting the site; and
11) plant structural integrity changes.
4.7 The scope and outcome of all reviews should be independently assessed and then considered by the Nuclear Safety Committee. Each review should be directed towards demonstrating that the safety case will remain valid until the next safety review occurs.
4.8 The arrangements should state that where a review reveals an inadequacy in a safety case for existing plant modifications to the safety case will be dealt with in accordance with LC22 arrangements.
4.9 The arrangements should specify the timescales for submission of documentation associated with reviews to the Executive, for the purpose of obtaining clearance for start-up or continued operation. (refer to assessment guide for timings).
4.10 The arrangements should ensure that:
1) the persons carrying out the review are suitably qualified and experienced persons.
2) a full and accurate report is made of each review, including a full list of current safety standards and principles, which is compiled, signed and authorised by the appropriate level in the licensee's management structure identified in the procedures before being submitted to the NSC or, if required, to the Executive.
3) any change to a safety case is managed in a similar manner to plant modifications (LC22).
4) reviews are carried out that are relevant to the current and projected status of plant, process or system "time of life" e.g. construction, commissioning, operation and decommissioning.
5) account is taken of the conclusions drawn from any review of the safety case.
6) the plant, process or system meets the original safety design requirements and/ or later standards as appropriate, including a full up-to-date description of the plant or process with any modifications clearly defined.
7) if any life limiting feature is identified that appropriate action is taken and the details reported under LC7.
8) ALARP arguments are made for any shortfall in achievement of modern standards, etc.
4.11 The arrangements should identify the person who has responsibility for reporting non-compliance with this condition to the Executive.
4.12 The arrangements should enable the licensee to respond to any Specification from the Executive. Such procedures should identify the person responsible for responding to the Specification and identify the system whereby constraints, caveats or conditions imposed by the Executive are implemented.
4.13 The arrangements should ensure that once approved under this licence condition by the Executive, they can only be changed or amended with the Approval of the Executive. The person(s) responsible for ensuring compliance with this requirement should be identified in the procedures.
4.14 The arrangements should ensure that the licensee responds to directions from the Executive to carry out a review and reassessment of safety and submit a report of such review to the Executive at such intervals, within such a period and for such of the matters or operations as may be specified in the Direction. The arrangements should identify a system whereby constraints, caveats or conditions imposed by the Executive are implemented.
5. Guidance on inspection of arrangements
5.1 Part 5 of this guidance is to assist inspectors in judging the adequacy of the licensee's arrangements. The following list of is neither exclusive nor exhaustive and will be subject to review and revision in light of operational experience. It does however provide a hit list of aspects of LC15 that can be examined during routine inspection.
5.2 Check that arrangements have been made to demonstrate compliance with the LC.
5.3 Examine the arrangements documentation layout and check that it is consistent. Review the arrangements to establish validity, whether any changes have been made since the last review and whether the identified responsible persons are correct. Note whether instructions, methods and quality assurance rules claimed in procedures have been followed and whether any changes have been correctly incorporated and validated.
5.4 Check that the arrangements identify the safety case and ensure there is a baseline for the review process which includes the suite of documentation at the correct revision status. Confirm that they state the means for achievement of an operational plant safety case may be such as by LC23 arrangements, with production and assessment of safety cases being carried out under LC14 arrangements.
5.5 Check that the arrangements identify appropriately tiered safety case reviews with a corresponding level of detail for each tier. Confirm that at least the following three types of review are included:
1) periodic shutdown reviews carried out at the time of periodic shutdown of the plant, process or system and reported upon at start-up meetings;
2) periodic safety reviews of plant, process and systems carried out at regular intervals (no longer than 10 years); and
3) "exceptional (or reactive) reviews" which have followed any event that may have lead to the safety case being questioned.
5.6 Check that the arrangements include all the aspects listed in para 4.6. If their scope is not as comprehensive as this, discuss with the responsible person identified in the arrangements.
5.7 Confirm that the arrangements require the scope and outcome of periodic safety reviews to be independently assessed and then considered by the NSC. Check that the arrangements state that the review process needs to demonstrate that safety cases remain valid for the period between reviews.
5.8 Ensure that the arrangements specify the timescales for submission of review-associated documentation to the Executive.
5.9 Check that the arrangements with respect to review activities ensure that:
1) the persons undertaking the review are suitably qualified and experienced persons;
2) a full and accurate report is made of each review, including a full list of current safety standards and principles, compiled and authorised at appropriate level in the licensee's management structure, before being submitted to the NSC or, if required, to the Executive;
3) any change to a safety case is managed in a similar manner to modifications under LC22;
4) reviews are carried out relevant to the current and projected status of the plant, process or system "time of life" e.g. construction, commissioning, operation and decommissioning;
5) account is taken of conclusions/ recommendations drawn from any review of the safety case;
6) the plant, process or system meets the original safety design requirements and/ or later standards as appropriate, including a full up-to-date description of the plant or process with any modifications clearly defined; and
7) any life-limiting feature is identified;
8) ALARP arguments are called up where shortfalls against modern standards/ modern safety cases are identified.
5.10 With respect to ensuring suitable interaction with the Executive, check that the arrangements:
1) cover a system for submission for approval to the Executive of those part or parts of the arrangements that may be specified;
2) contain such controls that any consequent amendments only take place with the Executive's approval; and
3) ensure that in response to a direction from the Executive a review and reassessment of safety will be undertaken and relevant reports submitted to a specified timescale.
6. Guidance on inspection of implementation of arrangements
6.1 Part 6 of this guidance is to assist inspectors in judging the adequacy of the Licensee's implementation of their arrangements i.e. is the licensee doing what their arrangements say they should. The following lists are neither exclusive or exhaustive and will be subject to review and revision in light of operational experience. They do however, provide a hit list of aspects of LC 15 that can be examined during routine inspections.
6.2 Prior to the inspection, discuss recent modification/ PSR safety cases with the assessment inspectors to identify weaknesses and strengths that need to be examined. Based on that information examine a sample of modifications in progress, or completed since the last inspection of this condition and establish that an adequate review of the safety cases were made. If any changes were made to a safety case, check that there was compliance with the requirements of LC14.
6.3 Discuss with the person responsible for organising the periodic shutdown that the following aspects are reviewed, in relation to the safety case(s), at the start up meeting held prior to start-up of the plant or system:
1) operating experience since the last review;
2) maintenance, inspection and testing experience since the last review;
3) modifications to the plant since the last review;
4) the history of incidents and abnormal events since the last review;
5) worker doses;
6) the accumulation and monitoring of radioactive waste;
7) radiation and contamination levels in and around the plant;
8) changes in safety standards;
9) changes to and behaviour of life-limiting items;
10) changes to the management of safety affecting the site; and
11) plant structural integrity changes;
6.4 Establish that the start-up review has been directed principally towards demonstrating that an adequate safety case is available for the start up of the plant or system and for the next period of operation.
6.5 Discuss with the responsible person(s) identified in the procedures the strategy adopted at the site for periodic reviews and judge whether there is a change in emphasis, detail or commitment.
6.6 Check that the scope and terms of reference for reviews are adequate. Note, discuss with and seek the advice of appropriate assessment units before accepting the review programme from the licensee.
6.7 Check that the scope and outcome of periodic safety reviews have been independently assessed and then considered by the Nuclear Safety Committee. Establish that the reviews demonstrate that adequate safety margins exist until the next periodic safety reviews are due.
6.8 Ensure that review reports are assessed by the appropriate assessment unit and an agreed action plan is produced for any area that does not meet current criteria and where improvements are considered to be reasonably practicable.
6.9 Ensure that an implementation programme is agreed and monitor the licensee's progress against such a programme. In the event of non-compliance consideration should be given, following discussions with the appropriate unit head, to enforcement action.
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