Risk Management FMEA For Medical Device
Risk Management tool according to FMEA (FMEA = Failure Mode and Effects Analysis) standard
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Using QPack FMEA Risk Managment helps you reducing the risk while developing your medical.
QPack integrates its FMEA based Risk Management tool in the application lifecycle management, allowing creating risk objects, manage risk properties such as RPN (= Risk Priority Numbers) , Mode of failure, cause of failure effect of failure and risk reduction.
Manage Risk Traceability
Each risk can be related to a specific requirement, or any other ALM artifact, and QPack integration with MS Word allows generating a risk management document according to the FDA regulations, with a click of a button.
Knowing the relevant risks for each requirement allows manager to manage better risk management, and take the right decision when preparing the work plan, and address the requirements where the risk is high.
The relations between risks and requirements in the risk management FMEA module allow traceability in both ways:
Show the risk related to a specific requirement or group of requirements
Show the requirement related to a specific risk.
Risk Management FMEA settings
The following image shows the custom colors for different RPN values, representing the acceptability, based on the failure cause probability (F1) and Failure mode severity (S1).
For example, the user can set a custom RPN for RPN value of 50 (S1=5, F1=10) and override the value "Unacceptable risk" with "Alart Region"
The section below the custom RPN table allows user to determine the RPN value for each acceptability (Acceptable Risks, Alart region, Unacceptable Risks), and set the colors of the acceptability, using 3 colors, based on the RPN value.
Risk Management FMEA - Managing risks
QPack Risk Management tool allows user to manage risks as follows:
The Above table shows the list of existing risks, with relevant parameters.
User can enter specific risk, or create new risks.
The above image illustrates the risk properties.
User can set the values, and the system calculates the RPN based on the risk management settings.
RPN calculation
The Risk Priority Number (RPN) is simply the product the Failure Mode Severity (SEV=S1/S2), Failure Cause Probability (PF=F1/F2), and Control Detection Effectiveness (DET=D1/D2) ratings.
RPN = (SEV) x (PF) x (DET).
Link risk to requirements
QPack allow to link risk to requirements, later on generated both in the requirements documents and the risk management document.
Benefits and uses of QPack Risk Management tool
- Identify action to address potential failure modes that have a high RPN.
- ALM artifacts (requirements, defects, etc) with high RPN needs immediate attention of the engineer since it indicates that the failure mode can result in a negative effect, its failure cause has a high likelihood of occurring, and there are insufficient controls to detect it.
- These actions might include redesign, testing, resource allocation, etc. - all of these activities are managed in QPack and can be traced later on, thus reducing the project risk.
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