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AcmeLi
Risk mangement plan
Product Number:
Life cycle phases for which this plan is applicable (tick all applicable)
Manufacturing process
End user
Verification
For completeness of plan the following must be verified:
Risk control
Responsibilities
Who will be responsible for the following?
Title Responsibility
Risk analsis team
Risk analysis
Risk evaluation
Risk control
Position
AcmeLimited Risk Analysis
Risk mangement plan
ments
Date:
AcmeLimited Risk Analysis
Intended use/purpose worksheet
Product Name:
Product Number:
Occurance
Detection
The above tables have been reviewed and accepted as the standard to be used for this Risk analysis of the
following product:
Signed
Position
AcmeLimited Risk Analysis
Occurrence
Action results
Detection
Recommended
Severity
Hazard Potential Failure Potential Effects of Potential causes of Risk index Resp. & target
Risk control method (SxOxD) actions for risk
ID mode (Hazard) Failure (Risk) failure completion date Action taken &
Index
Completion
Sev
reduction
occ
det
verification reference Date
-
AcmeLimited Risk Analysis
Occurrence
Action results
Detection
Recommended
Severity
Hazard Potential Failure Potential Effects of Potential causes of Risk index Resp. & target
Risk control method (SxOxD) actions for risk
ID mode (Hazard) Failure (Risk) failure completion date Action taken &
Index
Completion
Sev
reduction
occ
det
verification reference Date
-
AcmeLimited Risk Analysis
Risk reduction - Option analysis worksheet
Product Name:
Product Number:
Step 7 All residual risks shall be evaluated against the criteria defined in the risk management plan.
If the risk does not meet the criteria then a new risk assement and control measure plan (FMEA)
shall be implemented, if acceptable all relevent information necessary to explain the residual risks
shall be placed in the appropriate documentation supplied by the manufacturer.
k management plan.
ure plan (FMEA)
n the residual risks
AcmeLimited Risk Analysis
Risk Reduction - Risk/benefit analysis
Product Name:
Product Number:
Step 8 Does the medical benefit out-weigh the risk (s) involved?
To be completed if the risk is judged unacceptable and further risk control is impractical.
List all unavoidable risks list all medical benefits
Attach all evidence to report
The medical benefits have been/not been proved to outweigh the risks involved in using this device
We therefore judge this device to have an un/acceptable risk level an will inform the user of any residual risk
involved in the use of this device.
Signed: Date:
Position:
al risk
AcmeLimited Risk Analysis
Risk reduction - Generated hazards worksheet
Product Name:
Product Number:
Product Name:
Product Number:
Review all hazards listed in step 2 for completeness of risk evaluation, list any risk (s) that have been omitted
and enter onto new risk evaluation worksheet at step 3.
Sign: Date:
Position:
been omitted
AcmeLimited Risk Analysis
Overall residual risk evaluation worksheet
Product Name:
Product Number:
Step 11 Does the overall medical benefit out-weigh the residual risks involved?
List all unavoidable residual risks list all medical benefits
Attach all evidence to report
The medical benefits have been/not been proved to outweigh the risks involved in using this device
We therefore judge this device to have an un/acceptable risk level an will inform the user of any residual risk
involved in the use of this device.
Signed: Date:
Position:
al risk
AcmeLimited Risk Analysis
Risk Management report
Product Name:
Product Number:
We have studied the hazards and risks associated with the above product (s) and have judged
that the risk (s) arising from hazard (s) generated by the manufacture and use of this product are
of an acceptable level at this time. We will review any new risk (s) arising and update the risk
management file accordingly.
Signed: Date:
Position: