Issue Date:

23/12/02

Review Date:

23/12/05

Open Government Status:

Fully open

Approved By:

R C Gray

1. Purpose and scope

1.1 The purpose of this guidance is to facilitate a consistent approach to LC 21 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 that are likely to arise in inspecting for compliance with 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:

2. Licence Condition

Licence Condition 21: Commissioning

21(1) The licensee shall make and implement adequate arrangements for the commissioning of any plant or process which may affect safety.

21(2) The licensee shall submit to the Executive for approval such part or parts of the aforesaid arrangements as the Executive may specify.

21(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.

21(4) The aforesaid arrangement shall where appropriate divide the commissioning into stages. Where the Executive so specifies the licensee shall not commence nor thereafter proceed from one stage to the next of the commissioning 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 commissioning and shall where appropriate provide for the submission of this documentation to the Executive.

21(5) The licensee shall appoint a suitably qualified person or persons for the purpose of controlling, witnessing, recording and assessing the results of any tests carried out in accordance with the requirements of the aforesaid commissioning arrangements.

21(6) The licensee shall ensure that full and accurate records are kept of the results of every test and operation carried out in pursuance of this condition.

21(7) The licensee shall ensure that no plant or process which may affect safety is operated (except for the purpose of commissioning) until:

21(8) The licensee shall, if so notified by the Executive, submit to the Executive the safety case for the aforesaid plant or processes prepared in pursuance of paragraph (7) of this condition and shall not commence operation of the relevant plant or process without the consent of the Executive.

3. Purpose of Licence Condition 21

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, or 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 commissioning of a new or modified plant or process which may affect safety.

3.2 The term "commissioning" is defined in Condition 1(1) and this Condition applies to all commissioning activities whether on new or existing plant. The purpose of commissioning testing is to verify that the plant performs in the way expected by the designer and which was assumed in the plant's safety case. The tests performed should provide a progressive and systematic challenge and validation of the plant up to full design specification.

3.3 Specific requirements for decommissioning including strategies and programmes shall be progressed under arrangements made under LC 35.

4. Guidance on arrangements for LC 21

4.1 In addition to the general requirements for all Licence Conditions the licensee's arrangements shall satisfy the specific Licence Condition requirements which are :

4.2 It is during commissioning that the systems comprising the plant or process are tested and the arrangements should ensure a structured, systematic approach with appropriate controls at all stages.

4.3 Custom and practice has been to include commissioning requirements in a submission made under LC 22 for modifications to existing plants provided that there is clear linkage between the arrangements under LC 21 & 22.

5.Guidance on inspection of arrangements for LC 21

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 the minimum 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 for commissioning new plant, installation or modification 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 LC19, 20, 22 and 35.

5.6 Arrangements should allow NSD 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 modification 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 commissioning proposals to include adequate time for assessment of safety submissions by NSD 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 Arrangements should be in place for for tracking ALL commissioning work activities and linkages between them.

5.10 Arrangements should be in place for tracking and progressing technical queries, concessions, omissions and modifications arising from commissioning activities.

5.11 Arrangements should require that commissioning is undertaken in accordance with a quality plan or similar scheme which addresses:

5.12 Arrangements should require that the case for commissioning considers its impact on the live safety case.

5.13 Arrangements should recognise that where appropriate and notwithstanding the requirement for installation tests some benefit may be claimed for inactive commissioning activities undertaken outside controlled areas and or at manufacture's works.

5.14 Arrangements should identify the requirement for a progressive challenge to commission the plant. Such stages may include inactive, trace active before fully active commissioning.

5.15 Arrangements should require that there is a clear linkage to other supporting arrangements e.g. LC 12 SQEPs, LC14 Safety Documentation, LC20 Modifications to Design of Plant Under Construction, LC24 Operating Instructions and LC28 Examination, Inspection Maintenance and Testing.

6. Guidance on inspection of implementation of arrangements for LC 21

6.1 It is for inspectors 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 21 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 Inspectors should establish with the licensee the point at which the plant status moves from one of "installation" to one of "commissioning" and when commissioning has been declared completed by an appropriate authority.

6.4 Inspectors should ensure that the licensee identifies when the operating rules, safety mechanisms, devices and circuits, and maintenance schedule take effect. This point should occur prior to the introduction of radioactive material and becomes the point at which commissioning may attract more rigorous scrutiny from inspectors and may require the identification of a subset of the full operating rules or even additional rules specifically designed for the particular phase of commissioning.

6.5 Sample, check licensee's safety classification system for commissioning, challenge as necessary.

6.6 Sample, check that commissioning is undertaken in stages commensurate with the safety significance, (hazard presented both nuclear and conventional) and complexity of the plant to provide a progressive and systematic challenge and validation of the plant up to its full design specification.

6.7 Sample check that appropriate safety equipment is in place and tested and maintained and that appropriate liaison takes place with other regulatory bodies on topics such as CDM regs, fire certificate, discharge authorisations, prior to the commencement of that commissioning stage.

6.8 Sample, check for clear linkages between safety commissioning schedule(s) and safety case requirements.

6.9 Sample, check that commissioning schedules are supported by commissioning work sheets.

6.10 Sample, check the application of the licensee's process for progressing issues arising from commissioning including technical queries, concessions omissions and modifications.

6.11 Sample check the licensee's control of implementation of commissioning including:

6.12 Sample, check the licensee's system for appointing SQEPs to undertake commissioning.

6.13 Check/witness commissioning tests and records

6.14 Sample, check that a report is completed of commissioning and considered according to its safety classification by an appropriate overseeing body before commencement of the next commissioning stage.

6.15 Sample, check that, where relevant, the results of such tests are integrated into the safety case.

6.16 Where NSD consent is required to proceed beyond a hold point sample check that licensees due process has been completed in addition to the elements listed in the 6.11 above.