CSC-F-013-Hazard-Log-Template.md

qms_version	2.2.0
sop_id	CSC PR.002
sop_version	2.0.1
template_id	CSC F.013
template_version	2.0.1
record_version
record_id	HZ-001
title	Hazard Log

Hazard Log

General

Template ID	CSC F.013
Template Version	2.0.1
QMS Version	2.2.0
SOP ID	CSC PR.002
SOP Version	2.0.1
Regulatory References

Author
Approval

Scope

This document applies to {{device.name}} {{device.version}}.

Purpose

This document contains the outputs of the risk assessment conducted in accordance with the Clinical Risk Management Plan.

This document is meant to be read and agreed-upon by the project owners, the CSC team, and the Clinical Safety Officer (CSO) during design and development. It provides traceability for risk controls throughout the project.

Related documents

Document Title	ID
Clinical Risk Management Plan	CRMP-001
Clinical Safety Case Report	CSCR-001
Verification and Validation Plan	V&V-001

Hazard log

Hazard ID	Hazard	Possible causes	Effect	Harm	Severity	Likelihood	Initial risk	Risk Controls	Final Likelihood	Final Risk	Comment
{%- for risk in risk.risks %}
{{ risk.hazard_id }}	{{ risk.hazard }}	{{ risk.causes }}	{{ risk.effects }}	{{ risk.harm }}	{{ risk.severity }}	{{ risk.likelihood }}	{{ risk.risk }}	- {{ risk.risk_control }}	{{ risk.residual_likelihood }}	{{ risk.residual_risk }}	{{ risk.comment }}
{%- endfor %}

Hazard log - Verbose

{% for risk in risk.risks%}

{% if risk.hazard != None %}

ID : {{risk.hazard_id}}

Hazard: {{risk.hazard}}

Harm : {{ risk.harm }}

Cause : {{risk.causes}}
Effect : {{risk.effects}}
Initial Severity : {{risk.severity}}
Initial Likelihood : {{risk.likelihood}}
Initial Risk : {{risk.risk}}
Control Measures : {{risk.risk_control}}
Residual Probability : {{risk.residual_likelihood}}
Residual Risk : {{risk.residual_risk}}
Comment : {{risk.comment}}

{% else %} ID : {{risk.hazard_id}}
Cause : {{risk.causes}}

Effect : {{risk.effects}}
Initial Severity : {{risk.severity}}
Initial Likelihood : {{risk.likelihood}}
Initial Risk : {{risk.risk}}
Control Measures : {{risk.risk_control}}
Residual Probability : {{risk.residual_likelihood}}
Residual Risk : {{risk.residual_risk}}
Comment : {{risk.comment}}

{% endif %} {% endfor %}