Necessity of the Failure Mode and Effect Analysis (FMEA)
FMEA is used, in industries where faults of any kind can endanger people, e.g. in the automotive, aerospace and supplier industries. The continuous development of autonomous locomotion and the increasing use of more complex sensor technology often lead to customer demands for properly conducted failure analyses by manufacturers.
As a component of quality management, FMEA analysis is often used where the elimination of defects is associated with a low cost risk. In the form of FMEA software, it is often used in quality, development or product management departments of companies.
Automotive Industry as Benchmark of FMEA Analysis
The rapid development of drive technologies in motor vehicles, followed by stricter safety measures to reduce accidents caused by high speeds, make car manufacturers the pioneers of FMEA analysis. Where 50 years ago a seat belt in the car was sufficient to safeguard the driver, today it is a matter of complex systems consisting of cameras, sensors and airbags to safeguard all road users. The requirements of the German Association of the Automotive Industry (FMEA VDA) and the Automotive Industry Action Group (AIAG) are leading the way here.
While both automotive associations had their own guidelines on FMEA analysis until a few years ago, the first harmonized edition of the FMEA manual has been available since 2019 as a result of the collaboration between the two organizations. This serves as the basis for customer-specific sets of rules for failure analysis and failure prevention.
Advantages of Methodical Failure Analysis
An FMEA analysis according to VDA serves to ensure the production, availability, functional efficiency and reliability of a vehicle or machine. The demands of customers to reduce the technical risk of increasingly complex products and processes while at the same time increasing quality requirements, high pressure to optimize costs and in compliance with legal requirements form the basis of the harmonized FMEA VDA.
Due to the difficulty of considering all aspects accordingly, FMEA software is increasingly used as risk management software. Above all, it is used to realize a defect-free product launch. Where teams with employees from different areas used to spend hours brainstorming, the FMEA software collects information from all areas and simulates possible errors. Simulation up front reduces subsequent product changes with potential impact on the product lifecycle. Quality assurance is established, leading to customer satisfaction and long-term customer loyalty.
An advantage of the introduction of an FMEA solution for analysis is thus the cost reduction from complaints and warranty cases and associated damage compensation payments, which in the automotive industry can very quickly run into six figures.
In addition to the systematic tracking and realization of improvement measures through classical analysis, the use of FMEA software ensures the timely communication of all affected departments at any time and worldwide. The data preparation and storage fulfills the duty of verification with the necessary care according to the requirements of the legislator for product liability.
Due to the continuous development and the resulting legal changes, employees should regularly participate in FMEA training. This is the only way to ensure compliance with the current guidelines.
Daily Use of an FMEA Solution in the Company
FMEA analysis on web-based software offers several advantages for daily use in the company. One of them is the constant exchange of information between all relevant departments. For example, product development, design, quality assurance and sales each have access to the FMEA software platform. All information on each project is collected and updated on the web server, i.e. regardless of the time of day (possibly also due to different time zones) and department, each employee can post and also retrieve the latest findings. Time-consuming meetings that only serve to exchange the latest information on the topic are no longer necessary.
Likewise, each department has its own rhythm for performing failure analysis and risk assessment. The processing of a project via FMEA solution is time-independent, so that each department can continue the analysis at any time. While the classical execution of the FMEA VDA is connected with waiting times to a common meeting, the analysis with the FMEA software is processed by the omission of the waiting times in a short period, without intervening the work processes of all departments.
Another advantage is the up-to-dateness of the documentation to fulfill the obligation to provide evidence in terms of product liability. The documents are stored centrally and meet the current legal requirements. While employees learn about the latest changes through FMEA training, with FMEA software the update takes place online. The physical space required for documentation is also eliminated with the web-based solution.
Innovation Requires Information
Even when using FMEA software, one should always factor in attending FMEA training. On the one hand, the software is updated only on the technical side, which concerns, for example, the type of data on documents or their technical layout. On the other hand, changes in guidelines, which are connected with work process changes, are only taught in an FMEA training. The recent harmonization of VDA and AIAG guidelines underscores the importance of continuing education through regular attendance of FMEA training.
The harmonized FMEA standard from both guidelines is a first attempt to create a uniform standard for the American and European continent. The enforcement of a uniform work eases trade barriers and reduces difficulties in sales on the other continent. Compared to FMEA VDA, however, there are sometimes serious differences in the requirements according to AIAG, especially with regard to the evaluation of risks, evaluation tables and delimitations. Harmonization therefore inevitably leads to an increase in complexity in the analysis.
Failure to comply with the changes due to ignorance because of a lack of FMEA training can lead to a considerable competitive disadvantage vis-à-vis domestic and foreign competitors on the international stage. The multitude of dynamic standardization processes over the years requires even more the regular attendance of a FMEA training despite the use of the software.
Regardless of the use of risk management software, regular attendance of FMEA training as part of quality assurance serves to prevent additional costs for the company as a result of incorrect or incomplete analysis.