FMEA (Failure Modes and Effects Analysis) Risk Management
FMEA, known as Failure Modes and Effects Analysis, is a risk management and quality control methodology. This analysis is used to identify potential errors in advance and evaluate the effects of these errors, especially in complex systems such as production, design, or process development. Here are the basic principles and steps of FMEA:
1. Identification of Failure Modes
As the first step, potential failure modes within the system are identified. This includes issues that may arise in design, production, assembly, or process steps.
2. Determination of Failure Causes
Causes and possible origins are analyzed for each failure mode. This step is used to understand the probability of the failure mode occurring.
3. Evaluation of Failure Effects
Possible effects of each failure mode are determined. This includes assessing how the failure can impact customers, the production process, or other system components.
4. Evaluation of Failure Levels and Effects
Failure modes are combined with factors such as probability, severity, and detection probability to create a risk priority ranking. This step aims to identify the most critical and prioritized failure modes.
5. Development of Preventive and Corrective Actions
Based on the results of the FMEA analysis, the organization develops preventive and corrective actions. These actions involve steps taken to reduce the probability of errors or minimize the effects of errors.
6. Continuous Improvement of the Analysis
FMEA is a continuous improvement process. Analyses and the effectiveness of measures taken are regularly reviewed and updated as needed.
Key Advantages of FMEA
- Early identification and prevention of potential problems,
- Identification of continuous improvement opportunities,
- Enhancement of quality and reliability,
- Increase in customer satisfaction,
- Cost reduction.
FMEA is a widely used tool, especially in industries such as automotive, aerospace, pharmaceuticals, and defense, but it has also been widely adopted in other sectors.
Key Features of the FMEA Module:
Methodology Support
The module supports widely used risk management methodologies such as ISO 31000, FMEA.
Unlimited Parametric Field Support
Users can add and edit specific parameters for their organizations, providing flexibility.
Revision of Risk Magnitude and Historical Record
The magnitudes of identified risks are updated with revisions, and historical records are kept to track past risk situations.
Trend, Distribution Charts, and Reporting
The module provides trend analysis over time, distribution charts, and detailed reporting for identified risks.
Association and Integration
The module associates risks with other areas of the organization, allowing for an integrated view of risk management.
Follow-Up on Measures
Measures taken against identified risks are tracked with Corrective and Preventive Actions (CAPA), document, and action modules.
Output of Risk Form in Desired Format
The module allows users to obtain a risk form output in the desired format.
Approval Hierarchy Linked to Risk
Predefined approval hierarchies for specific risk levels can expedite and enhance the risk management process.
Automatic Action Alert System
An automatic action alert system for certain risk levels allows quick intervention in critical risk situations.
These features enable the organization to effectively manage and continuously improve its risk management processes in various areas.