Office for Nuclear Regulation

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Assessment of NNB GenCo QMS audit of Framatome

Executive summary

Purpose of Intervention

NNB Generation Company (HPC) Ltd (NNB GenCo), the licensee for Hinkley Point C (HPC) has contracted Framatome to deliver the reactor coolant circuit who, in turn, sub-contract work to other manufacturers. NNB GenCo assesses its major suppliers partly through a formal audit of the supplier’s quality management system (QMS) and targeted assessments. NNB GenCo are conducting a series of QMS audits of Framatome’s major sites which includes the heavy manufacturing facility at St Marcel.

The purpose of the intervention described here was to understand and judge the adequacy of NNB GenCo’s arrangements for:

Interventions Carried Out by ONR

Licence Condition (LC) 19 requires that “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”.

The intervention was conducted through an ONR observation of NNB GenCo conducting a QMS audit at the Framatome heavy manufacturing facility at St Marcel, France. Through its level 4 engagements, ONR understands that the QMS audit forms part of its overall assessment and that it will be complemented by targeted assessments.

NNB GenCo’s audit was performed over two days by two auditors who assessed Framatome’s QMS against the requirements of ISO 9001:2015. The audit was largely office based with two visits to the work area; I observed the audit over both days and joined one of the visits to the work area.

Explanation of Judgement if Safety System Not Judged to be Adequate

This was not a system-based inspection.

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

In my opinion, the auditors demonstrated a suitable level of competency and experience in the requirements of ISO 9001:2015 and in carrying out audits against this standard. This judgement is based upon the audit scope (that was provided prior to the audit) and by observing the auditors conduct the audit. Prior to visiting St Marcel I sought the opinion of ONR quality experts who informed me that, in their opinion, the scope of the audit was adequate in assessing Framatome St Marcel’s QMS arrangements but that the duration of the audit appeared to be too short to explore all of the items in depth. This appeared to have been recognised by the auditors who informed me that there was a constraint of two days for each of the Framatome audits and ideally they would have liked longer. I recognise that this audit was part of an overall programme of audits at different Framatome sites.

In some areas, the audit appeared to be poorly supported by Framatome who did not provide the appropriate experts (primarily for records management) according to the audit schedule; the auditors noted this and stated that the audit report would conclude that not all areas were covered in depth.

The auditors sought evidence for Framatome’s implementation of their QMS and in my opinion the priority given to each of the items on the audit scope was appropriate. The audit generated several important findings; I expect NNB GenCo to seek timely closure of these findings as part of the audit process and for the nuclear island team to consider what additional action should be taken.

In my opinion, the audit would have been more effective if it had been supported by technical staff that had knowledge of the manufacturing arrangements for the HPC primary circuit. There appeared to be a considerable amount of manufacturing of HPC items in progress and technical support could have directed the audits to particular areas of interest. In particular, because of the relatively short duration, technical support may have improved the efficiency of the audit.

Conclusion of Intervention

Through my observation of NNB GenCo’s QMS audit I was satisfied that, when it is combined with the findings from the audits at the other Framatome locations, it is likely to provide NNB GenCo with an adequate assessment of Framatome’s QMS and its implementation.

NNB GenCo recognised that they will need to complement the QMS audit by more targeted assessments to gain adequate confidence that Framatome will deliver items of appropriate quality for HPC. ONR will continue to monitor NNB GenCo’s arrangements and seek evidence that these assessments are providing the required assurance.

I was satisfied that the intervention was successful in meeting its intended objectives. Based upon the above findings I have assigned a rating of green with regard to NNB GenCo’s arrangements for conducting QMS audits and the contribution of the QMS audit in assessing Framatome as a supplier of NSSS items for HPC.