About the course
A one-day practitioner course on running clinical risk management for real: operating a proportionate clinical safety management system, writing the clinical risk management plan for a system of systems, facilitating hazard workshops, handing risk over from manufacturer to deployer, and keeping safety assurance current in live service.
Learning outcomes
- Write a clinical risk management plan (CRMP) and shape a clinical safety management system (CSMS) that scale assurance effort to clinical impact
- Plan, facilitate and record a hazard assessment workshop that finds the hazards that matter
- Transfer and accept risk across manufacturers, deployers and connected systems, and keep it under control in live service
The modules
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Welcome
Where Part 1 left off
A short recap of the clinical risk management process and the documents that carry it.
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CSMS
Clinical safety management system
The foundation for everything else. The main principles of an organisation-wide CSMS — top management commitment, accountability, competence, defined processes, records, audit and continual improvement — and risk proportionality through clinical impact triage: categorising each system as minor, intermediate or major impact and scaling assurance to match.
Exercise: complete a clinical safety capability assessment across direction and focus, assurance and improvement, safety climate, and people and skills.
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Module 1
Clinical risk management plan, including system of systems
Starting with the bigger picture: mapping the systems, data flows and organisations around a deployment, finding interface and emergent hazards (missing, late, wrong or misrouted information), and agreeing who owns each boundary. That map becomes the scope of the plan. Then what to include in a CRMP and why each part matters — from scope, intended use, roles and competence through to risk acceptability criteria, interfaces, change control, monitoring and review.
Exercise: map the discharge pathway, then define a CRMP for it.
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Module 2
Hazard assessment workshops
Planning a workshop that finds the hazards that matter: scope, the right people, pre-work and process maps. Facilitation techniques including structured what-if (SWIFT), guidewords and bow-ties. Handling dominant voices and quiet clinicians, and recording hazards, causes and controls so they go straight into the hazard log.
Exercise: take turns to facilitate a live hazard workshop on a worked example.
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Module 3
Manufacturer (DCB0129) to deployer (DCB0160) handover
How to articulate and transfer risk: what the manufacturer must hand over, writing transferred controls a deployer can act on, and how the deploying organisation imports, localises and re-rates supplier hazards. Agreeing ownership and running the handover meeting.
Exercise: a handover role-play between the manufacturer and the hospital.
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Module 4
Maintaining the clinical risk management file in live service
Keeping the safety case true after go-live: post-market surveillance and monitoring linked to hazards; change management and impact assessment for releases, configuration and interfacing systems; turning incidents and near misses into hazard log updates; periodic review and re-triage; and knowing when to re-baseline or retire a system.
Exercise: plan the first year of live service for a worked example.
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Close
Summary and next steps
Reflection on the learning outcomes, a short action plan for your own organisation, and signposting to templates and further resources.
Who this course is for
Clinical Risk Management in Practice is built for CSOs, clinical safety coordinators and safety engineers who already hold Part 1 knowledge and are ready to go deeper into practical implementation. If you've completed a recognised Part 1 practitioner course elsewhere, you don't need to repeat it — you can join ORTHON directly at Part 2.
Format, price and next steps
This course is £400 per person.
Training a whole team? We offer reduced rates for closed courses delivered exclusively for your organisation, minimum 10 attendees — enquire about closed courses.