FMEA: Definition, Implementation, Benefits
An investigation that detects errors as early as the production phase is called Failure Mode Analysis. FMEA stands for Failure Mode and Effects Analysis. With the support of FMEA, errors are found and analyzed. The errors are eliminated. Afterwards, solutions are sought that prevent the errors from occurring in the first place. In this way, one can ultimately influence production and maintain the good reputation of a company.
There is another reason for using an FMEA: Failure analysis not only uncovers errors in planning or production. With the help of FMEA, production costs can be kept at a low level. If the errors are detected earlier, the possibility of them occurring again later and causing high costs is reduced. FMEA is thus suitable for cost analysis.
Requirements and guidelines
The specifications and guidelines, which are intended to provide more assistance than instructions for the correct execution of an FMEA, vary from industry to industry. For medical technology, the requirements for an FMEA are determined by the Medical Devices Act. Furthermore, DIN EN ISO 13485 and DIN EN ISO 14971 must also be observed. In the food industry, the requirements of HACCP are taken into account. HACCP stands for the Hazard Analysis an Critical Control Points concept. The pharmaceutical and chemical industries must adhere to the guidelines of the German Drug Law and the German Medical Law when using FMEA analysis.
The corresponding legal requirements and DIN standards are explained in more detail in FMEA training and are also taken into account in the development and production of FMEA software.
FMEA types and operation
The mistakes that can be made during the development of a product are very diverse. Accordingly, the possibilities for error analysis can be divided into three types. System FMEA focuses on the safety and functionality of the method. The design FMEA looks for possible sources of error in the design of the products. A process FMEA starts at the base of the production chain and identifies possible errors in the production designs.
The operation of an FMEA is much more advanced today than in the early days. While in those days the search for errors was often accompanied by a pad and pencil, computer-aided operation is now much faster. However, in the case of some errors, the tried and tested method still has to be used if errors are to be recorded. For this purpose, forms have been developed that can be adapted to the specific needs of the individual industry. These forms are filled out by the employees who accompany the troubleshooting process. Once the data has been recorded, specialists are entrusted with further processing. The results serve and support the internal risk management. Controlling also benefits from the key figures recorded during the FMEA. Ultimately, this is where the decisive information is provided that initiates the cost-reducing measures.
Benefits of an FMEA analysis
The main purpose of an FMEA is to detect as many faults as possible that can occur during the development and production of a product. However, the primary goal also uncovers other results that not only justify the use of an FMEA, but can even make it indispensable.
Customers will be delighted when they hold a fault-free product in their hands. This not only ensures satisfaction for them, but can also have a marketing effect on the manufacturing company through word-of-mouth propaganda. In internal operations, the results of an FMEA analysis support the development and planning of new products. The approach is completely different when you know where errors can occur.
The FMEA analysis has proven itself in the past. More and more manufacturing companies are relying on it to detect errors at an early stage. FMEA software is very helpful for this purpose. It also makes sense to prepare the employees concerned for their use in an FMEA training course.
The main area of application of an FMEA is in the production process. Here, already during the development of the products, care is taken to ensure that no errors occur. The same procedure is followed if products are changed or an update of the product is necessary. Sectors in which FMEA is used include medical technology, the aviation industry, automotive, electronics, plant and mechanical engineering as well as service and industrial companies.
For a better support and correct use of FMEA a special software is used. An FMEA training informs the participants about the possibilities that an FMEA provides and about the exact procedure in the company.
Advantages of the FMEA software
The use of FMEA software specially programmed for troubleshooting has shown that the employees not only save mountains of paper during their work, but also provide all those involved in the process with an overview that leaves no questions unanswered. With the help of the software, the errors in the processes are to be documented and the results presented in a comprehensible form. In addition, a specially developed software makes it possible to adapt the results to the different company divisions without much effort. A prerequisite for this is, of course, that the software meets the common general requirements, but at the same time covers the needs of the individual company. A software considers in particular that different product ranges of a company can have different sources of error. A program for troubleshooting offers individual solutions and especially ensures that the information is processed correctly. The use of a software saves not only money but also time. In addition, the motivation of the employees increases when they finally bring a faultless product to the market.
Advantages of FMEA training
In addition to specially designed software, the use of an FMEA also requires that employees know how an error analysis is carried out and which tasks they are entrusted with during its implementation. Furthermore, they must of course know how the software used in their company works. All relevant information is provided to participants of an FMEA training course. In addition to the functionality and application areas of an FMEA and the software used, concrete examples are presented during the FMEA training and those weak points that can trigger errors are examined more closely. In addition, an FMEA training course provides the necessary system understanding of the software and makes every participant a good user.
During the planning and development of products, errors often creep in, which can trigger high costs. This not only affects the economic situation of the company, but also its reputation. In order to prevent this from happening in the first place, the errors must be nipped in the bud. If sources of error are identified during the planning and development of a product, high costs can be avoided.
The use of an FMEA is a sensible solution. An FMEA analysis is suitable for companies for quality assurance and cost savings. A prerequisite is that the employees have been trained in the course of an FMEA training and can use a special FMEA software to carry out an FMEA. The advantages of FMEA software cannot be denied. In addition to the clarity that a program offers, it is designed to meet the needs of the company using it and to quickly identify weaknesses. Thus, errors are quickly corrected without much effort. FMEA training supports the use of the software and turns participants into good users.