Failure Mode and Effects Analysis
A Failure Mode and Effects Analysis (FMEA) is a generally valid analytical method in quality management and is considered standard in many companies today. It is used to find potential errors in products before they occur. Appropriate actions are then implemented to prevent these potential errors from occurring. The process or product to be evaluated is thus assessed in terms of the impact for the customer, likelihood of occurrence and likelihood of detection, using key figures. This enables the process to be adjusted using the appropriate methods.
FMEA is used to increase technical reliability. In quality management, this means that an FMEA must be carried out before the product is produced, i.e. in the early development phase – the product evolution process. This is because the earlier preventive actions are started, the more effective they are. FMEA as a method is used in the automotive, aviation and aerospace sectors in particular, but has spread to other industry sectors as well. Today, FMEA is also used for quality assurance in the project management and service industries.
The objective of the Failure Mode and Effects Analysis is to prevent failures instead of discovering them at some point down the line and having to pay (sometimes extensively) in order to fix them. An FMEA also determines potential weak points and critical components. This helps to prevent costs from being incurred in production or by the end user. In addition, the knowledge gained from the FMEA can be used in other new products. FMEA also offers further benefits by supporting risk assessment, shortening development time, reducing costs and reducing the manpower needed to rectify errors. Ultimately, it helps to achieve the corporate quality objectives.
The ISO 9001:2015 quality management standard requires companies to be more aware of risks. This standard defines a risk as an effect of uncertainty on an expected result. According to this standard, companies are obliged to determine potential risks and evaluate them. As a modern method for risk management, FMEA can help to fulfill the ISO 9001:2015 requirements when determining and evaluating potential risks.
Die FMEA wird in unterschiedliche Bereiche unterteilt: Je nach Zeitpunkt der Anwendung und betroffenem Objekt wird zwischen der Konstruktions-FMEA für ein Produkt (Entwicklungs- und Konstruktionsphase) und der Prozess-FMEA für ein Herstellungsverfahren (Produktionsplanungsphase) unterschieden. Außerdem untersucht die System-FMEA das übergeordnete Gesamtsystem und das Zusammenwirken der Teilsysteme darin.
An interdisciplinary team with participants who usually come from the design, development, production planning, production and quality management departments is responsible for the FMEA. Forms or appropriate software are required for the analysis. This ensures that presentation is clear and well-ordered.
Firstly, a potential failure location is found by applying past experience and the specialist expert knowledge of the people involved. Then the type of failure is determined, the failure is described and classified using a risk priority number (see below). Next, the cause of the failure should be identified. If the cause of failure is known, then generally actions for preventing the failure can be implemented. Suggestions for solutions should focus on preventing the failure, and not simply on detecting it.
The risk priority number (RPN) is used to sort the individual risks into the order that they are to be processed in. The RPN is calculated according to the significance, likelihood of occurrence and likelihood of detection of the failure. This classification can ultimately be used to decide which failures need to be processed first.