Guidance: LC14 Safety documentation

Site inspection and enforcement

T/INS/014 - Issue 1

Issue date:: 22.04.03
Review date:: 31.12.10
Open Government Status:: Fully open
Approved By:: B J Furness

1. Purpose and scope

1.1 The purpose of this guidance is to facilitate a consistent approach to LC 14 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 14.

3) Guidance on inspection of arrangements.

4) Guidance on inspection of implementation of arrangements.

2. Licence Condition

2.1 Licence Condition 14 - Safety documentation

14(1) Without prejudice to any other requirements of the conditions attached to this licence the licensee shall make and implement adequate arrangements for the production and assessment of safety cases consisting of documentation to justify safety during the design, construction, manufacture, commissioning, operation and decommissioning phases of the installation.

14(2) The licensee shall submit to the Executive for approval such part or parts of the aforesaid arrangements as the Executive may specify .

14(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.

14(4) The licensee shall furnish to the Executive copies of any such documentation or any such category of documentation as the Executive may specify .

3. Purpose of Licence Condition

3.1 The purpose of this Condition is to ensure that the licensee sets up arrangements for the preparation and assessment of the safety related documentation comprising safety cases to ensure that the licensee justifies safety during design, construction, manufacture, commissioning, operation and decommissioning. It should be noted that LC 14 does not require a safety case to demonstrate the safety of that operation. This requirement is made in LC23 (Operating Rules).

3.2 The safety case will comprise a suite of pre-defined safety documentation which, in its component parts, covers the various project stages and which, taken together, comprise the safety case for the plant throughout its life. For each phase of the installation's life the licensee's arrangements should specify the format, content and purpose of each safety document. They should address the suitably qualified and experience requirements (SQEP) for persons responsible for its production, together with those for other suitably qualified and experienced persons responsible for control and supervision of implementation of the arrangements.

3.3 The arrangements should show how safety documents are categorised in accordance with their safety significance. The safety significance of the document should determine the extent of review and assessment and whether or not it is then submitted to the NSC for consideration and advice. When classifying safety significance it is not the considered risk but the potential hazard arising directly or indirectly, during or after the activities under consideration, that must be considered. This should include any hazard arising from inadequacy in conception or execution.

3.4 Safety cases should refer to the licensee's own safety criteria and standards and provide an analysis to demonstrate that risks have been reduced to as low as reasonably practicable. Safety testing and inspection that need to be undertaken during manufacture, construction or commissioning should be identified to enable their translation into relevant manufacturing, construction or commissioning documentation. The licensee may decide to split major projects or modifications into stages and provide a safety case for each stage. For projects or modifications of minor safety significance, a safety case is still required but some or all of the documentation may be combined or omitted as appropriate.

3.5 The arrangements should include provisions for the safety cases to be written, independently assessed and peer reviewed as appropriate. In all cases, the documents should be reviewed and approved by SQEP staff of an appropriate level within the licensee's management before the particular activity is started. This peer review may comprise internal design validation and verification. It should include a check that hazards have been properly identified, that assumptions made comply with accepted criteria and that standards and methods to evaluate consequences are in accordance with recognised and accepted procedures.

3.6 Independent assessment should be carried out by persons independent of the groups responsible for the production of the safety case and for operations, and it should provide a detailed overview based on a rigorous safety assessment. After review and any assessment the NSC may need to consider the safety documentation. This requirement should be explicit in the licensee's arrangements.

LC14(1) provides for the making and implementing of arrangements for the production and assessment of safety cases through the life of the plant.

LC14(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.

LC14(3) ensures that where the Executive has approved arrangements the Licensee must apply for approval to amend or alter these arrangements

LC14(4) gives the power to the Executive to require the licensee to furnish any safety documentation that the Executive may specify in order that the NII can satisfy itself, by its assessment process, that the safety claims made by the licensee can be substantiated. This primary power is rarely used, documentation is usually provided by the Licensee in accordance with their arrangements, providing NII with a derived power.

4. Guidance on arrangements for LC 14

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]. Note: some of the activities undertaken by the licensee for compliance with LC 14 may be carried out by non-site based staff i.e. licensee's staff and/or contractors. It may be necessary to inspect arrangements (interview staff and examine documentation) off the licensed site i.e. corporate centres and or contractors' offices).

4.2 Arrangements should be provided to comply with LC 14.

4.3 Arrangements shall address all the licence condition requirements

4.4 Arrangements should include clear reference to the processes and safety classification system drivers for safety documentation (safety cases). i.e LC 19 new plant, LC 23 operating rules, LC 22 modifications etc. The classification system for new plant or processes or modifications that may effect safety (including changes to safety cases) should be hazard based, and should take account of the activities which they substantiate being inadequately conceived or executed during the design, construction, manufacture, commissioning, operation and decommissioning phases of the installation (plant or process).

4.5 Arrangements should include an adequate regulatory interface process between the NII and the licensee to ensure that sufficient time is included in safety documentation submissions programmes for assessments by NSD and/or other regulators. Arrangements are expected to contain procedures which allow NII to call in for review any category of safety documentation and, if required, allow NII to place hold points beyond which the licensee does not proceed without NII agreement.

4.6 Arrangements should ensure that the interaction and impact of any safety submission to all other relevant safety justifications is visible, documented, monitored and controlled.

4.7 Arrangements should require that criteria are developed for the scope, format and content of all safety documentation.

4.8 Arrangements should require persons producing, (or revising), reviewing, approving and independently assessing safety documentation to be SQEPs.

4.9 Where a Licensee uses contractors to produce whole, or parts of, safety cases the arrangements should ensure that the contractors used are appropriate for the work to be undertaken and that the individuals involved are SQEPs. The arrangements should include a robust system of control of the whole safety case production process including the initial choice of contractor, criteria for assessing the competence of contractor before, during and after the production of the safety case.

4.10 Arrangements should include robust processes for verification, review and independent assessment of safety documentation commensurate with safety significance.

4.11 Arrangements should include an endorsement and approval process for safety documentation commensurate with safety significance.

4.12 Arrangements should ensure that the licensee maintains and controls all documentation to support their safety cases and the documentation is readily retrievable.

4.13 Arrangements should ensure that the responsibility for ownership of safety cases is clearly defined at all times during the plant's life cycle.

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 is neither exclusive or exhaustive and will be subject to review and revision in light of operational experience. It does however, provide a hit list of aspects of LC 14 that can be examined during routine inspections.

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 arrangements include clear reference to the processes and safety classification system drivers for safety documentation (safety cases). i.e LC 19 new plant, LC 23 operating rules, LC 22 modifications etc.

5.5 Confirm that the arrangements include an adequate regulatory interface process between the NII and the licensee. This often includes flowsheets and should include indicative timings for all stages of the process. Establish that the arrangements support the "derived power" frequently used by NII to control safety documentation (see section 4.5).

5.6 Check arrangements ensure that the interaction and impact of any safety submission to all other relevant safety justifications is visible, documented, monitored and controlled.

5.7 Confirm arrangements require that criteria are available for the scope, format and content of all safety documentation and that they are actually available.

5.8 Check that the arrangements require persons producing, (or revising), reviewing, approving and independently assessing safety documentation to be SQEPs. Note these persons may be Licensee's staff or contractors.

5.9 Confirm that the arrangements include a robust system of control of the whole safety case production process including the initial choice of contractor, criteria for assessing the competence of contractor before, during and after the production of the safety case.

5.10 Confirm arrangements include processes for verification, review and independent assessment of safety documentation commensurate with safety significance. Check the process for ensuring independent review is carried out by SQEP persons independent of the originator(s).

5.11 Confirm arrangements include an endorsement and approval process for safety documentation commensurate with safety significance.

5.12 Check that the arrangements contain a system to ensure that the licensee maintains and controls all documentation to support their safety cases.

5.13 Confirm that arrangements should ensure that the responsibility for ownership of safety cases is clearly defined at all times during the plant's life cycle.

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 list is neither exclusive or exhaustive and will be subject to review and revision in light of operational experience. It does however, provide a hit list of aspects of LC 14 that can be examined during routine inspections.

6.2 Sample/check the arrangements documentation layout and 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: check whether instructions, methods and quality assurance rules claimed in procedures have been followed and whether any changes have been correctly incorporated and validated.

6.3 Sample/check that safety case documentation is readily retrievable and accessible by those persons required to use it, that it is up to date, validated and adequately controlled.

6.4 Sample/Check that only SQEPs are carrying out the production and assessment of safety cases. Where outside organisations are being used to prepare and assess safety cases, confirm that the licensee has adequate arrangements to ensure that only SQEPs are used by outside organisations and that these arrangements are being adequately implemented.

6.5 Prior to the inspection, discuss with assessment inspectors the perceived strengths and weaknesses of recently submitted safety cases. Based on this information, sample/check examples of completed safety documentation and that it has been reviewed, assessed and approved in accordance with the licensee's arrangements. Challenge the licensee's safety classification system as necessary.

6.6 Sample/check that the interactions of safety submissions on all other relevant safety justifications is visible, documented, monitored and controlled.

6.7 Check whether the Executive has requested approval of arrangements and that such approval has been obtained. Where any constraints are imposed, check that they have been followed with clearance by a SQEP before proceeding further. Check that any alteration or amendments to approved arrangements are being treated similarly.

6.8 Sample/check that safety documentation has been subject to appropriate review and assessment by suitably qualified and experienced persons who are independent of those producing them or their eventual implementation and that the review covers:

1) all safety implications are addressed;

2) a review of the safety classification

3) verification that proposals meet design intent and appropriate design standards.

6.9 Sample/check that safety documentation has been subject to independent assessment and that where the assessment is carried out by an outside organisation, that there is certification or endorsement by the licensee, by person(s) independent of those producing or implementing the documentation. Compare NII assessment of recent safety case(s) with the conclusions of the independent safety review to establish the rigour and quality of the independent review process.

6.10 Sample/check that safety documentation has been considered by the NSC were appropriate (see also LC 13 guidance).