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Stage 5 Managing Product Delivery

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Risk Evaluation, Control and Review

Finalise Hazard Log
The Hazard Log is reviewed and finalised by the CSC project team, ensuring it is a comprehensive and accurate reflection of all the hazards, causes, controls related to the digital solution, and the relationships between them.

Collate Evidence of Controls
Relevant documents that serve as control evidence continue to be documented on the Controls Evidence List and added to the CRMF.

Complete Scoring of Controls
Each control is scored as:

  1. Weak, Medium or Strong
  2. Existing, Additional or Potential
  3. Full or Partial

For more information on these categories, see Risk Controls.

Residual Risk Scoring
Based on the additional evidence of controls, the residual risk scoring of each hazard is completed and justifications for the assigned scores are documented.

Finalise Clinical Safety Case Report (CSCR)
The CSCR is finalised and reviewed by the wider NCSAS team.

Updated on 27 May 2024
Stage 4 Managing Product DeliveryStage 6 Managing Product Delivery

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