Scope and Hazard Identification
Hazard Workshop
Hazard workshops consist of an introduction to hazards, causes and controls, before moving into an interactive mind map session. Participants are asked for their input to identify any patient safety issues that should be considered and to explore ways of ‘designing them out’ or mitigating the risk before wider implementation of the digital solution.
Multiple hazard workshops may be held, depending on the complexity of the solution in question and the amount of discussion required to draw out the relevant information.
SME sessions
SME sessions are run in addition to larger hazard workshops to allow participants to focus on a particular area of the digital solution. These sessions involve a small number of SMEs with expertise in a particular area e.g. cybersecurity.
Develop Hazard Mind Map
One or more mind maps are used to collate information during project initiation, hazard workshops and SME sessions. As required, these are reviewed, combined and further developed to ensure all of the relevant information regarding hazards, causes and controls is captured in one place.
Information Spreadsheet
As we progress through the CSC process, key pieces of information that benefit from being highlighted in the final Clinical Safety Case Report often surface. These are captured in a separate spreadsheet for future reference.
Issues clinics
If the digital solution under scrutiny is already live and in use, it is useful to run issues clinics. These sessions allows users and SMEs to report known or developing issues and discuss their resolution.
Controls review
As the CSC team work through the programme documentation, workshops and SME sessions, evidence of existing controls may be provided. This information is reviewed and recorded on the controls evidence list to be used when developing the Hazard Log.
Initial categorisation of controls
Each control is categorised as:
- Weak, Medium or Strong
- Existing or Potential
- Full or Partial
For more information on these categories, see Risk Controls.
Consolidate CRMF
The file should continue to be populated and reviewed over the course of the CSC.