At Synapse DS, we guide NHS and social care organisations through DCB0160 compliance — the official clinical risk management standard for deploying, using, maintaining, and safely retiring clinical software. We make the process clear, structured, and stress-free, so you can focus on delivering safe, effective care.
What is DCB0160?
DCB0160 is a statutory NHS England standard that ensures all health and care organisations identify, assess, and manage clinical safety risks when implementing or operating Health IT systems. It’s the organisational counterpart to DCB0129, which applies to manufacturers and suppliers. If your organisation uses clinical software in the NHS or adult social care, DCB0160 compliance is not optional — it’s a legal requirement under the Health and Social Care Act 2012.
Checklist of required documents:
Clinical Risk Management File
Signed Clinical Risk Management Plan (CRMP)
Up-to-date Hazard Log with residual risk rationale
Explore our three-phase approach to see how we drive growth and efficiency at every step.
Step
01
Governance & Roles
Nominate your Clinical Safety Officer (CSO) and set up governance.
Step
02
Planning
Create a Clinical Risk Management Plan (CRMP), define risk acceptability criteria, and gather supplier safety evidence.
Step
03
Hazard Identification
Map your workflows, configurations, and interfaces; log potential hazards.
Step
04
Risk Evaluation
Decide which risks are acceptable and which need controls.
Step
05
Risk Controls
Implement controls, verify effectiveness, and update the hazard log.
Step
06
Build the Safety Case
Prepare your Clinical Safety Case and produce a Safety Case Report (CSR).
Step
07
Pre-Deployment Review
Check all controls are in place, hazard log is up to date, and CSR is CSO-approved.
Step
08
Go-Live Monitoring
Put incident reporting in place and review safety regularly.
Step
09
Change Management
Assess and document the safety impact of updates, patches, or configuration changes.
Step
10
Ongoing Monitoring
Ongoing hazard log and incident reporting, review and amendments with new and/or removed features and updates.
Step
11
Safe Decommissioning
Apply the same process to system retirement, including data migration.
Hazard Identification Comparison
Digital Clinical Safety: Hazard Identification Methods
Comparing three key methodologies for healthcare technology risk assessment
🔍
HAZID
Hazard Identification
Overview
Traditional systematic approach derived from process industries, adapted for healthcare IT systems. Uses structured workshops to identify potential hazards.
Process
Divide system into components or nodes
Use guide words (What if, How could)
Multidisciplinary team discussions
Systematic documentation
Best For
Large-scale systems, complex infrastructure, early design phases, comprehensive baseline assessments
Strengths
Comprehensive coverage
Structured methodology
Well-documented
Limitations
Time-intensive
Resource-heavy
Can be overly formal
🌳
FFT
Functional Flow Tree
Overview
Hierarchical, visual approach mapping system functions and workflows. Traces potential failures through functional dependencies.
Process
Map system functional architecture
Create tree-based flow diagrams
Trace dependencies and interactions
Identify failure propagation paths
Best For
Systems with complex workflows, integration points, process-driven applications, understanding cascading failures
Strengths
Visual representation
Shows relationships
Good for workflows
Limitations
Complex for large systems
Requires detailed knowledge
Maintenance overhead
⚡
SWIFT
Structured What-If Technique
Overview
Streamlined, scenario-based approach using structured "what-if" questions. Faster and more flexible than traditional HAZID.
Process
Prepare what-if prompt list
Facilitate structured brainstorming
Apply prompts to system elements
Rapid capture and assessment
Best For
Agile environments, rapid assessments, change evaluations, resource-constrained projects, iterative development
Strengths
Time-efficient
Flexible approach
Easy to learn
Limitations
May miss details
Facilitator-dependent
Less systematic
Quick Comparison Matrix
Attribute
HAZID
FFT
SWIFT
Time Required
High (weeks)
Medium-High (days-weeks)
Low (hours-days)
Resource Intensity
High
Medium
Low-Medium
Formality
Very Formal
Formal
Semi-Formal
Learning Curve
Steep
Moderate
Gentle
Documentation
Comprehensive
Visual + Detailed
Focused
Agile Compatibility
Low
Medium
High
Team Size
6-12 people
4-8 people
3-6 people
Best Stage
Early design
Design/Development
All stages
Coverage Depth
Very Deep
Deep
Broad
Clinical Alignment
DCB0129/DCB0160
DCB0129/DCB0160
DCB0129/DCB0160
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