FMEA is one of several core statistical analysis tools that can improve the quality management system of organizations. FMEA is used across industries and is one of the best tools to analyze potential reliability problems early in the development cycle. The method helps organization to take action and minimize failures. The ability to identify problems early allows organizations to outline a process flow that incorporates reliable, safe, and customer-friendly features into the sequence. In addition to Excel spreadsheets, customized FMEA software has been used for some time.
Technical Quality Management
FMEA and risk management are important in a wide variety of industries. One industry where AIAG FMEA and risk management are central components of quality management is the automotive industry. In the summer of 2019, the Quality Management of the German Association of the Automotive Industry (VDA QMC) and the American Automotive Industry Action Group (AIAG) published a joint standard for failure mode and effects analysis (FMEA). It is considered the benchmark and is described in the American automotive AIAG standard as well as in the German-language AIAG & VDA FMEA manual.
For FMEA, there is specially developed software based on the AIAG FMEA findings that helps to implement transformative and sustainable improvements within organizations of all sizes and levels. Various educational institutions offer FMEA training and seminars on how to use FMEA software. Within an FMEA training course, knowledge and skills for the harmonized AIAG-VDA FMEA are imparted. Step by step, users learn in an FMEA training how to use analysis tools optimally and how to present the results in a comprehensible way.
Guidelines for the FMEA Application
In the course of the development of FMEA analysis, different approaches were followed. Especially in the automotive industry, where the AIAG FMEA originated, there was a great need for criteria to be used for risk assessment. There was also a search for uniform approaches to present the results of an AIAG FMEA for communication with customers. The individual processing of data from the AIAG FMEA often resulted in additional work, since the manufacturers of the products or components often had very different orientations. For this reason, the two FMEA guidelines according to AIAG FMEA (Automotive Industry Action Group) and VDA FMEA (Verband der Automobilindustrie) were combined and unified, so that there is now a new, uniform standard.
The focus of the new AIAG FMEA guideline is now on a systematic procedure in seven steps and on uniform criteria for risk assessment. The significance of possible failure consequences and the probability that a failure or failure cause will occur and be detected in time are evaluated. On this basis, the "priority for action" is used to determine how urgently measures are required to reduce the risk for all identified risks.
Use of VDA/AIAG FMEA Alignment Standards Used in the Company
With the alignment of standards according to AIAG FMEA, which includes VDA analysis and AIAG analysis, risks are no longer only assessed, but the need for action is also presented in three levels (high, medium, low). This method proves to be very effective in evaluating both new and existing processes and systems. For new processes, it identifies potential bottlenecks or unintended consequences before implementation.
Once it has been decided that a performance improvement project on a process should be carried out using the AIAG FMEA method, the first step is to set up a project team for it. The next step is to work with management to establish a charter that will help the team manage the scope of the project and ensure that the changes implemented reflect the FMEA method.
The selected team members have day-to-day responsibility for performing one or more steps of the AIAG FMEA Method process. It is critical to the success of the project that the team members are always up-to-date on the current status. The number of people on the project team depends on the scope of the process. There should be at least one representative from each employee group involved in the process. They also discuss the use of appropriate FMEA software, provide information about the benefits and regularly attend FMEA training.
Use of FMEA Software in the Company
FMEA software provides flexible and scalable solutions that allow individual steps of the AIAG FMEA process to be defined and later combined into a cross-functional integrated solution. This allows individual modules to be expanded to support an enterprise-wide network with users in multiple locations. Solutions are typically designed to automatically import data from a variety of sources.
With the right FMEA software and basic FMEA training, basically any type of analysis can be performed. Special learning modules teach how to use FMEA software. FMEA analysis can thus be easily linked using reliability block diagrams and fault trees to convert the results of the FMEA analysis into a representative reliability model. The use of FMEA software in the company enables the creation of a continuous knowledge repository of VDA FMEA and AIAG FMEA results that can be reused throughout the quality process. In most cases, related analyses such as P-diagrams, DVP&Rs (test plans), Design Reviews Based on Failure Mode (DRBFMs), process flow diagrams and process control plans are also supported.
FMEA Training - Efficiency through Further Training
Why is it so important that responsible persons complete an FMEA training in order to correctly apply FMEA according to the new VDA/AIAG alignment? Customized FMEA software is important for companies of all sizes. It saves money and time and thus enables the entrepreneur to concentrate on his main task and the importance of the company.
In an FMEA training course, the seven essential steps of an AIAG FMEA method are described and taught in an industry-specific manner.
- Planning and preparation
- Structural analysis
- Functional analysis
- Failure analysis
- Risk analysis
- Documentation of the results
In an FMEA / AIAG FMEA training, knowledge is imparted on how the FMEA is planned and prepared. For this purpose, certain definitions such as goal, team, milestones, evaluation basis, methodology and depth of consideration are determined. The structural analysis will help to keep track of the FMEA steps. In it, the scope that was defined in the first step is visualized and depicted in a clear representation.
An FMEA training teaches all important steps of the FMEA analysis. This includes the functional analysis, which creates understanding for the product or process. During the failure analysis, seminar participants learn how to systematically derive possible failures from the functional analysis already performed and how to link them on the basis of the structure. In the risk analysis, the measures already in place or planned are described. On this basis, the training participants learn how to evaluate the probability of occurrence and detection of the fault or cause.
This is followed by optimization according to the FMEA / AIAG FMEA guidelines, in which new measures are jointly developed in accordance with the previously defined priority for action, which serve to reduce the risk. The documentation, which is usually done in a form, belongs to the last step of the analysis. It also allows a check on whether the newly introduced measures are effective and whether the predicted risk reduction has been achieved.