RISK ANALYSIS

Document #:
Project Description:
Project #:
Author:
Revision:

APPROVALS REQUIRED:

Project Team Members:

Engineering – (Name)
Marketing – (Name)
Regulatory – (Name)
Quality – (Name)
Manufacturing – (Name)
Planning – (Name)
Purchasing – (Name)
Clinical – (Name)
Documentation – (Name)
– (Name)

APPROVALS/DATES MAINTAINED ELECTRONICALLY WITHIN THE AGILE SYSTEM

Revision Description of Change

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1.0 PURPOSE

2.0 SCOPE

3.0 SUMMARY OF HAZARDS

3.1

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4.0 RISK ANALYSIS

Project:
(Table 1)

Part
Date
Rev.
Hazards Arising From Product Design
Hazard Investigation/Controls

Occurrence

Importance
Severity

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 (Table 2)

Part
Date
Rev.
Risk Matrix

Occurrence Severity

Severe Major Minor Negligible

Frequent H H I I

Probable H I I L

Occasional I I L T

Remote I I L T

(Table 3)

Estimation of Risk Codes

H High Risk must be reduced

I Intermediate Reduce risk to ALARP, cost a minor factor

L Low Reduce risk to ALARP, consider cost/benefit

T Trivial Broadly acceptable

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 (Table 4)

Occurrence Severity of Consequences

Codes Consequences
Codes Patient Product Clinical Study

Potential death or
product damaged, Clinical trial outcome
Frequent F > 5% Severe S permanent injury
loss of customer jeopardized

Potential serious product damaged, Will affect clinical trial

Probable P > 3% Major Ma injury, not permanent customer will notice results

minor damage to
Potential minor injury, May affect clinical trial
Occasional O > 1% Minor Mi not permanent
product, customer
results
may notice

Potential minor negligible damage to

Remote R  1% Negligible N discomfort, not product, customer
Won't affect clinical
trial results
permanent won’t notice

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