Part of Curriculum level 3 - guidance
Module 3.4 - Identifying the scope of safety assessment
This module focuses on defining the clinical context and scope for risk management, including intended use, users, patients, care settings and care processes, and the consequences of poor scoping.
This module will provide:
Knowledge
- Importance of intended use, users, patients, care settings and care processes
- Consequences of poor scoping for downstream safety activities
Skills
- Defines and documents risk management scope
- Challenges vague or unsafe scope definitions
Behaviours
- Patient-centred mindset
- Avoids scope creep without reassessment
Learning outcome 4
Demonstrates understanding of how to define clinical context and scope.
Content guidance
1. Defining intended use and users
Articulating the system's intended clinical purpose.
Defining user groups, patient populations and care settings.
Out-of-scope statements — saying what the system does not do.
2. Scoping in practice
Gathering context from stakeholders, including front-line clinical users.
Recognising and challenging vague scope statements.
Managing scope changes through reassessment.
Last edited: 16 July 2026 9:45 am