This risk management datasheet is used to conduct a Failure Mode and Effects Analysis (FMEA) on a process step and key input. It involves identifying potential failure modes of the input, their effects and severity, potential causes, existing controls, actions to improve prevention and detection, and recalculating the risk priority number after completing actions.

1. RISK MANAGEMENT DATASHEET
Itemunder
study
Prepared
by:
Page _____ of _______
Group
Members
FMEA Date: FMEA NO._______
Next
Review
Date:
ProcessStep/
Input
Potential Failure
Mode
Potential
Failure Effects
Severity
Potential Causes
Probabilityof
Occurrence
Current Controls
Detection
RiskPriority
Actions
Recommended
Resp.Person
ActionsTaken
Severity
Probabilityof
Occurrence
Detection
RiskPriority
What is the process
step andinput under
study?
In what ways does the
key input goes wrong?
What is the impact
ofthe quality and
safety ofthe
product/
material/patient?
What causes thekeyinput togo
wrong?
What aretheexisting controls that
prevent thecauseor failuremode
What aretheactions
for preventing or
reducing the causeor
improving detection
What arethe
completed actions
taken withthe
recalculatedRPN