FMEA (Failure Mode and Effect Analysis) is a systematic risk analysis method used to identify potential failures in products, processes and systems or services assess the potential effects of these failures and proactively manage risks. Developed in the aerospace industry in the 1960s it is now widely applied in automotive, manufacturing or health and electronics and many other sectors.
Failure Mode and Effect Analysis is a structured method used to proactively detect potential failures in a product, process or system and assess the impact of those failures. This method assesses how potential failures may occur what consequences they may cause and the probability and severity of these failures. It is usually used during the design or production phase of a product to identify potential problems in advance and take measures to prevent these problems from reaching the customer or end user.
Failure Mode and Effect Analysis is an important risk management tool used in various industries and its different types are customised according to the application area. The main types are:
Design
It is implemented during the design stage of a product or system. This analysis is used to identify potential defects that may occur in the components or subsystems of the product and to evaluate the effects of these defects on product performance. It aims to increase the reliability of the design and its compliance with customer requirements. For example in the design of a car's brake system possible failures in brake components are identified and the potential effects of these failures on safety are analysed. It is implemented early in the product development process to eliminate defects before they arise.
Process
It is employed to assess possible errors that might occur during the production process and their impact on the quality of the product. PFMEA takes into account factors such as equipment used in the production line human factors and material quality and environmental conditions. The aim is to prevent defects from occurring in the production process improve quality and reduce production costs. By performing PFMEA on a production line errors that may occur during assembly such as incorrect assembly or equipment failures are identified and the effects of these errors on product quality are evaluated. It’s crucial to address potential issues that may arise during the production phase proactively.
System
It is utilized to detect and analyze potential faults that could impact a system's overall performance. This type of analysis assesses the impact of failure in one component on the entire system taking into account the interactions between all components and subsystems of the system. SFMEA is commonly applied in the development of large intricate systems. For example in the design of an aircraft system these analyses possible failures in subsystems such as the hydraulic system or electrical system and software and the effects of these failures on flight safety. It is an essential measure for boosting the system's overall reliability.
Service
It is used to identify and analyse potential faults that can affect the performance and quality of a service provided in the service sector. This type of Failure Mode and Effect Analysis focuses on service operations such as customer service maintenance and repair processes. The goal is to avoid potential service interruptions and enhance customer satisfaction. By using SFMEA in the customer support process a telecommunications service provider can identify potential failures in the handling of customer complaints and analyse the impact of these failures on customer satisfaction.
Software
It is used to identify potential errors that may be encountered during the development of a software and the effects of these errors on the performance of the software. This type of analysis is critical to prevent software errors from leading to system failures or security vulnerabilities. Software Failure Mode and Effect Analysis is often used in software systems that are particularly safety-critical for example in medical devices or automotive software. It focuses on issues such as coding errors user interface problems and data integrity.
Hardware
It is used to assess the potential faults that may be encountered in a hardware system and the effects of these faults on the functionality of the hardware. This type of analysis is particularly common in projects involving physical components such as electronic or mechanical and electrical systems. It can be used in the design of a computer motherboard where the likelihood of component failure and the impact of those failures on overall system performance are evaluated.
Business FMEA
It is used to assess potential failures in an organisation's business processes and their impact on business performance. This type focuses on business processes such as strategic planning supply chain management and customer relations. The goal is to enhance the overall efficiency of the business while effectively managing risks. By using it in a company's supply chain process potential risks such as supplier delays or quality problems are identified and the effects of these risks on the business are analysed.
The Failure Mode and Effect Analysis process is a systematic approach to identifying potential defects in a product, process and system or service assessing the possible consequences of these defects and reducing risks. This process usually consists of several basic steps. The initial step is to select the product, process or system for analysis and establish its boundaries. Subsequently the team identifies potential failure modes (how a component, process or system might fail) and the probable causes of these failures.
For each failure mode the possible effects are analysed and a risk priority number (RPN) is calculated which assesses how serious the failure mode is how often it can occur and how easily the failure can be detected. These calculations are usually done with a scoring system where severity or probability and detectability criteria are used. Remedial actions are then developed and implemented for defects with a high RPN value. The process is completed by recalculating the RPN scores to assess the effectiveness of the proposed corrective measures.
Design FMEA is conducted during the design stage of a product or system, prior to the start of production. This analysis is performed to identify possible weak points and potential failure modes of the design at an early stage. It is applied during the concept development and detailed design process so that engineers and design teams can assess risks in the design and take mitigating measures before proceeding to the production phase. Performing in a timely manner prevents defects from escalating to the point where they require expensive correction later improves product reliability and helps meet customer expectations.
RPN (Risk Prioritization Number) is a numerical value used to determine the importance and priority of potential failures identified in the process. RPN is calculated by multiplying three key factors: Severity, Occurrence and Detection. Severity indicates how serious the consequences of a failure are probability indicates how often the failure can occur and detectability indicates how easily the failure can be recognised. The RPN is a key tool in the process to prioritise risks and develop risk mitigation strategies using resources in the most effective way.
Risk analysis is performed to manage risks by identifying potential failures with a systematic approach and evaluating the possible effects of these failures. The process starts with a team effort and a detailed description of the product or process or system to be analysed. Next the team identifies potential failure modes; this describes the different ways in which each component process or system can fail. For each failure mode identified the possible causes and the effects that these failures can lead to are analysed. In the next step the Severity, Occurrence and Detection factors for each failure mode are scored between 1 and 10 and the Risk Priority Number (RPN) is calculated by multiplying these scores. The obtained RPN values determine the priority with which the risks will be addressed. Risk mitigation strategies are created and executed for errors that have a high RPN.
In Failure Mode and Effect Analysis the Risk Priority Number (RPN) is computed to evaluate the risk level associated with potential failures. RPN is obtained by multiplying three main factors: Severity, Occurrence and Detectability.
The higher the RPN value the greater the risk and the more urgent the intervention needed.