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Who controls and is responsible for the FMEA?

What is FMEA(Failure Mode and Effects Analysis)

Failure Mode and Effects Analysis (FMEA) is an engineering technique used to confirm, identify, and eliminate the known and potential failures, problems, and errors in system design, process, and service before products are sold to customers. That is to say, through the implementation of FMEA, the product defects can be identified in the prototype stage or before mass production.  

Failure Mode and Effects Analysis

Four Types of FMEA

1. System FMEA (also called Concept FMEA)

It analyzes systems and subsystems during the early concept and design phases.  System FMEA is mainly aimed at the potential failure modes between system functions caused by system defect. System FMEA needs to consider the interaction between systems and internal system components. 

2. Design FMEA

It analyzes the product prior to the production phase. The design FMEA is concerned with failure mode resulting from design defects. 

3. Process FMEA

Analysis is carried out during production and assembly.  The process FMEA is concerned with the failure mode due to manufacturing or assembly defects.  

4. Service FMEA

It analyzes the service before the product reaches the user. The service FMEA is concerned with failure modes (tasks, errors and defects) that result from system or process defect.  

Who controls and is responsible for the FMEA?

The system engineer is responsible for the system FMEA. The system engineer ensures that the FMEA result is updated in time and the FMEA tasks are allocated reasonably. The assignment of FMEA tasks are carried out through the control document, and the system FMEA tasks should be at least assigned to the product engineer, design engineer and quality assurance personnel.  

The design engineer shall be responsible for the design FMEA, and the design engineer shall ensure that the design FMEA is updated in time and the tasks are reasonably assigned. The design FMFA is assigned through the control documents, and the FMEA tasks shall at least be assigned to the design engineer, product engineer, manufacturer and quality assurance personnel.  

The system engineer is responsible for the process FMEA. The system engineer ensures that the FMEA is updated in time and tasks are assigned reasonably. The assignment of the FMEA is carried out through the control document, and the process FMEA tasks should at least be assigned to the design producer, design engineer and quality assurance personnel.  

The department manager is responsible for the service FMEA. The department manager ensures the FMEA is updated in time and the tasks are assigned properly. The assignment of the FMEA is done through the control document, and the tasks of service FMFA should at least be assigned to the managers in the affected area, marketing department and quality assurance personnel.  

Special Remarks for FMEA

Any enterprise should and could apply FMEA for any problem.  FMEA’s ease of operation and thinking of dealing with problem proactively is not only used to identify the system, design, production, and service problems, but also integrate with other tools to assist in identifying and resolving issues such as safety, maintenance planning, access, downtime impacts, etc. It is unwise to only apply FMEA or similar tools to limited production processes. FMEA is a tool that can be widely used.  

More Notices for FMEA

First of all, the FMEA staff must notice that don’t turn the FMEA into a very “busy” work, and ignore the work “value”.  FMEA can easily fall into the erroneous zone of “analysis paralysis”.  

Furthermore, it needs to be noted that in the implementation of any level of FMEA, can not stop because of the following excuses:   

  1. We never did that.  
  2. We’re not ready to do that.
  3. We can do without it.  
  4. We tried once, but it didn’t work.  
  5. It costs too much.
  6. It’s not our responsibility.
  7. This doesn’t apply here.  

Finally, it needs to pay attention to the forecasting techniques used for the system (concept), service and quality FMEA. If you are interested in studying these techniques further, you can refer to any book on statistics.  

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