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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 determined, these hazards and risks are analyzed and evaluated through existing controls, and the processes are followed. In addition;

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?

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

You can record the existing and/or undetected error types/effects in products and processes.
You can identify the causes and effects of errors.
You can prioritize errors based on probability, severity, and discoverability.
By working on potential errors, you can relate them to production, service, or other parts. • You can create a probability rating table, taking into account the frequency of occurrence of the error type.
Depending on the size of the coefficient, you can decide whether to start improvement activities or not.
You can determine the control points necessary to eliminate your recorded errors and problems and reduce their effects, and you can plan and follow your precautionary activities.
It is compatible with all risk methodologies. It has a completely flexible and user-defined infrastructure. You can adapt the risk methodology applied in the institution.
You can create a risk scoring system specific to the institution and make your evaluations.
You can group risks separately according to different categories such as location, department, process, service, product, and report and monitor them.
There is a precautionary tracking system that works in integration with the CAPA and Action modules of QDMS for nonconformities that arise as a result of all FMEA analyses. You can use the precautionary tracking system for your FMEA forms.
If you want measures to be taken for nonconformities resulting from FMEA analysis, you can contact the Instruction, Procedure, etc., which is integrated with the QDMS Document Management module.
Actions opened during the precautionary follow-up process are automatically notified to the relevant parties via e-mail. You can follow the stages of the actions and report the work that is not done within the deadline to the superiors.
You can provide authorization control over FMEA analysis forms. You can prevent users from gaining unauthorized access and making changes to FMEA forms.
FMEA forms can be exported to Excel in the desired format and reported. If desired, a detailed report of a single FMEA item can also be obtained.
FMEA forms can be revised, you can monitor the old and new status of the revised forms both instantly and on the trend graph.
Thanks to the "Maximum Analysis" and "Comparison" graphics, it is possible to show impact, severity, detection, limit, risk priority number, etc. or department, location, etc. You can get comparison/analysis charts by dimensions.
If desired, you can pass the FMEA forms through the approval stages, and you can publish the risk forms that have passed the approval process through the system.
You can define “control” points on your FMEA forms and ensure that control measures are taken into account while evaluating.
Heat Map analysis report is automatically extracted from the system. You can analyze your risk distributions with this report and prioritize your risk studies.
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