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FMEA Risk Management

What is FMEA Risk Management?

It is the module where the hazards that may occur on the basis of process, system, design and service are identified, these hazards and risks are analyzed and evaluated through existing controls and the processes are followed. In addition to this;

Supporting all common methodologies
Creation of historical record with revision of risk sizes
Precautions; Tracking with CAPA, Document, Action modules
Getting a risk form printout in the desired format
Unlimited parametric field support
Automatic precautionary warning system for certain risk levels
Trend, Scatter Charts and Reporting
Establishing the desired approval hierarchy based on risk
Legislation, process, supplier, customer, product group, workplace etc. associate with fields such as

What are the Benefits of FMEA Risk Management?

FMEA (Failure Modes and Effects Analysis) is a systematic method for evaluating potential failure modes, their causes, and effects in a product or process. The goal of FMEA is to identify areas of concern before failures occur, enabling teams to prioritize and address risks. In this process, potential failure modes are identified, their severity, likelihood, and detectability are assessed, and the potential effects on the system or process are determined. Based on these evaluations, corrective actions can be taken to reduce or eliminate risks.

With the AIAG VDA-compliant FMEA module, you can document existing and/or potential failure modes/effects in products and processes.
It works in conjunction with control plans, allowing you to define control points necessary to eliminate or reduce the effects of documented failures and problems, and plan and track preventive actions.
While performing failure analyses for your processes, you can easily create and track the interconnected steps of Structure Analysis, Function Analysis, Failure Analysis, and Optimization.
The FMEA module has a user-friendly interface.
FMEA should be reviewed in response to any nonconformities. In this context, you can easily review FMEA based on customer complaints and internal nonconformities, as the FMEA module is integrated with the Customer Complaint and CAPA modules. When creating any Complaint or CAPA records, you can link them to the relevant FMEA and generate review tasks.
You can define the causes and effects of failures.
You can find the likelihood, severity, and detectability tables within the module, and based on these values, the AP priority values will be automatically calculated, allowing you to determine the priority of failures.
By working on potential failures, you can proactively identify and address failures and their preventive actions.
There is a corrective action tracking system integrated with QDMS’s Action Modules for any nonconformities that arise from FMEA analyses.
You can use the action tracking system for your FMEA forms. In the action tracking process, actions are automatically notified to responsible individuals via email. You can track the status of actions, and report tasks that are not completed within the set deadline to higher management.
You can apply access control on FMEA forms, preventing unauthorized users from accessing or making changes to the forms.
FMEA forms can be exported to Excel for reporting.
You can revise FMEA forms, send revisions through the approval workflow, and view revision histories.
Generic FMEA information defined in the system can be used across different products that share common processes.
You can track pending tasks in the FMEA module using the "Pending Tasks" page.