Office for Nuclear Regulation

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NNB GeNco, HPC LC 17 - Quality Management arrangements for NSSS (NSSS6)

Executive summary

Purpose of Intervention

This intervention was conducted at NNB Generation Company (HPC) Limited’s (hereafter called NNB GenCo) Hinkley Point C (HPC) Bridgewater House offices and undertaken as part of the ONR intervention plan, HPC Project Intervention Plan beyond J0.

Interventions Carried Out by ONR

I conducted a Licence Condition (LC) 17 (Management Systems) compliance inspection targeted on the nuclear steam supply system (NSSS). This involved sampling the adequacy and effectiveness of the quality management arrangements relating to NSSS and sample evidence as to its effectiveness.  

The focus of the intervention was NNB GenCo’s Management System arrangements for the NSSS, in particular, the identified quality measures for delivering the balance of the NSSS items. The purpose of the intervention was for ONR to judge whether the NNB GenCo Quality Management arrangements and improvements provide adequate assurance that the components delivered by the NSSS Programme will fulfil the requirements of the safety case. 

I assessed NNB GenCo’s LC arrangements against relevant good practice, which included ONR regulatory guidance.

Key Findings, Inspector's Opinions and Reasons for Judgements Made

I have concluded that based on the discussions and the evidence provided on 20 February 2020, the knowledge and experience of the representatives interviewed during the inspection to be good. NNB GenCo demonstrated an improved level of collaborative engagements within the Quality Function and an increased focus in targeted areas of safety significance. However, ONR recognise the proposed improvements relating to the quality measures for NSSS and the reorganisation of the NNB GenCo Quality Function are yet to be fully implemented and demonstrate sustainable improvements.

NNB GenCo highlighted the development of a risk based approach to influence assessments, audit plans and modulation of manufacturing surveillance. However from the evidence presented, it was unclear how the risk based approach had been applied and implemented.

NNB Gen Co demonstrated a level of oversight for the proposed NSSS quality improvement measures; however I consider NNB GenCo engagement and oversight of the NSSS proposed quality measures should be more rigorous and intrusive, to ensure the appropriate quality standards are achieved. 

I noted shortfalls in the timely production of management system documents and arrangements relating to the NSSS as a number of documents presented during the intervention were still in draft status and not implemented. It is noted the manufacture of NSSS components continues at pace from a complex supply chain. 

I observed that NNB GenCo have recognised that the Root Cause Analysis (RCA) for non-conformances performed by Framatome requires improvement to consider the wider implications, and that NNB GenCo should apply an increased level of scrutiny on the output of the RCA.

From the records presented and sampled, I consider that an area for improvement for  NNB GenCo consideration is improved clarity within records to demonstrate and confirm that the NSSS items are of adequate quality, and that all the specified requirements have been achieved and fulfilled. I recommended that NNB GenCo should consider inclusion of overarching affirmative evidence or similar in the end of manufacture reports to clearly demonstrate the specified requirements have been achieved.

From the evidence sampled and discussions held, it is recognised that Framatome have identified longer term quality improvement measures, however it was unclear what short term  quality measures are proposed to address or respond to weak signals which require  immediate and  prompt mitigating action in the short term.

Conclusion of Intervention

Overall I have concluded that an inspection rating of AMBER seeks improvement is appropriate for   LC17 – Management Systems. Areas of good practice were highlighted, and I acknowledge that further developments are planned. However, I found shortfalls in the maintenance, implementation and consistent deployment of management system arrangements and completion of records.

While NNB GenCo are overseeing the implementation of the Framatome quality improvement measures at several levels, I consider that this should include more intrusive challenge. I consider that NNB GenCo’s current LC17 Management System arrangements for NSSS require improvement.

A regulatory issue will be raised the findings from this intervention. The findings will also be used to inform a revision of related regulatory issues 6834, 7201 and 7540.