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Synergy Health Sterilisation UK Ltd (Reading Site) Transport - Inspection ID: 52245

Executive summary

Date(s) of inspection:

  • January 2024

Aim of inspection

The purpose of the inspection was to review compliance of the dutyholder’s arrangements for class 7 radioactive material for road transport.

Subject(s) of inspection

  • Transport (Non-nuclear) Appropriate management system - Rating: Green
  • Transport (Non-nuclear) Contingency plans in accordance with IRR Reg 13 - Rating: Green
  • Transport (Non-nuclear) Dangerous Goods Safety Advisor subsection 1.8.3 ADR - Rating: Green
  • Transport (Non-nuclear) Designation of Controlled or supervised areas Reg 17 IRR17 - Rating: Green
  • Transport (Non-nuclear) Emergency arrangements - Rating: Green
  • Transport (Non-nuclear) Local rules Reg 18 IRR17 - Rating: Green
  • Transport (Non-nuclear) Radiation Protection Adviser Reg 14 IRR17 - Rating: Green
  • Transport (Non-nuclear) Radiation Risk Assessment Reg 8 of IRR 17 - Rating: Amber
  • Transport (Non-nuclear) Security Plan - Rating: Green
  • Transport (Non-nuclear) Sub contract arrangements - Rating: Green
  • Transport (Non-nuclear) Training - Rating: Green
  • Transport (Non-nuclear) Transport documentation - Rating: Green

Key findings, inspector's opinions and reasons for judgement made

The inspector identified a number of examples of the dutyholder meeting relevant good practice in reducing risk to levels that are ALARP, including suitable IRR17 registration and consent, appropriate local rules, contingency plans and a comprehensive set of procedures and arrangements covering all aspects of transport.

The inspector identified one area of non-compliance associated with the radiation risk assessment. This was discussed during the inspection.

Conclusion

The inspection findings were presented to Steris at the close of the inspection.

I judged an overall inspection rating of green was appropriate for this inspection, as relevant good practice was generally met, with only minor administrative shortfalls identified, when compared with appropriate benchmarks.

Steris is required to provide to ONR either with evidence that the identified non-compliance has been resolved, or an appropriate resolution plan with timescales for completion, by the 22 March 2024. The non-compliance will be tracked to completion via a Level 4 Regulatory Issue.