This method is used in the development and continuous improvement of products and processes.
The FMEA method is a tool for quality management and achieving efficient production of competitive products. The purpose of the method is to improve the quality and ensure sustainable, efficient production of competitive products and processes by preventing the appearance of defects (failures) or reducing the negative consequences of them.
Algorithm of application.
Action Plan:
Recognition and evaluation of potential defects and /or failures of products or processes and their consequences.
Determine actions to eliminate or reduce the likelihood of potential defects and (or) failures.
Documenting all these activities.
The result of the application of the method is to eliminate or reduce the likelihood of potential defects and (or) failures in products and manufacturing processes at such important stages of the product life cycle as its development and preparation for production.
Advantages of the method. FMEA (Failure Mode and Effects Analysis) is a systematised set of measures that allow:
- identify potential defects and failures that may occur during the application of the product or the functioning of the process.
- determine the main causes of their appearance and possible consequences.
- develop actions to eliminate these causes or prevent possible consequences. FMEA fits perfectly into the set of tools for ensuring product quality and creating competitive advantages that every enterprise should have.
- helps manufacturers prevent defects, improve product safety and customer satisfaction.
- Quite simply mastered by specialists.
Structured approach with the purpose of:
- Forecasting defects and prevention of their occurrence in production and others functional industries where defects appear.
- Identify methods in which a process may not meet critical customer requirements.
- Assess the significance (severity of the consequences), the probability of detection and the frequency of defects.
- Evaluate the ongoing control plan to prevent the occurrence of these defects.
- Prioritize the actions that need to be implemented to improve the process.
Process defect type and consequence analysis is applied in three main cases, in each of which attention is paid to different points:
Case 1:
New designs, technologies, or process
The subject of analysis of the types and consequences of defects is the design, technology or process as a whole.
Case 2:
Changes in an existing design or process.
Analysis types and consequences of defects should be focused on changes in design or process, possible interaction caused by changes, and the history of operation. May include changes in regulatory requirements.
Case 3:
Applying an existing design or process in new conditions, location, sphere or profile usage (including duty cycle, regulatory requirements, etc.)
Analysis types and consequences of defects should be focused on the impact of new the conditions, location or use of the existing structure, or process.
Types of analysis of types and consequences of defects:
- Analysis types and consequences of system defects: used for system analysis and subsystems in the early stages of design and concept creation. Attention is paid to the types of potential failures caused by the structure, related to the functions of the system.
- Analysis of types and consequences of design defects: used to analyze products before release into production.
- Analysis of the types and consequences of process defects: used to analyze production processes and business processes.
- Analysis types and consequences of equipment defects: used for analysis types of defect in the equipment used in the process.
More about FMEA Method
The FMEA method appeared in USA in the mid-sixties and was used for the first time in the development of the Apollo spacecraft project, and then in medicine and nuclear Technique. In the 80s, the method was further developed under the name FMEA and found application also in the automotive and other branches of industry produced in the UNITED STATES, and then in Europe and Japan. In some areas of industrial The production method has become the basis of quality assurance.
The FMEA method is a systematized set of activities, the purpose of which is detection of the location of possible finding of potential product failures and process, identifying actions that can eliminate or reduce the likelihood of their occurrence, and documentation of all these activities.
FMEA Method Helps Manufacturers prevent defects, increase safety products and customer satisfaction. This method aims to “Embedding” quality in products, so it should be applied as possible earlier, at least until production begins. However, his the application may also be useful for manufactured products and of a functioning process.
Similar methodology FMEA Method of analysis of types and consequences potential defects, focused primarily on automotive industry.
The essence of this methodology rests on the “three pillars”.
1.
The First “Whale” can “swim on its own” in an ocean of quality. Any defect (failure) the article (or assembly) in question can be sufficiently fully characterized with just three criteria:
- Significance measured in terms of the severity of the consequences of the failure.
- Relative frequency (probability) of occurrence.
- Relative frequency (probability) of detection of this defect (failure) or its cause on another the manufacturer.
For each of these the criteria have their own scale of expert assessments in the range from 1 to 10. And this scale is increasing, that is, the greater the significance or frequency of occurrence the higher the estimates.
Integral a (generalise) estimates of the criticality of a given failure is calculated as the product of three evaluations according to the three specified criteria and represents the priority risk coefficient. This generalise estimate can take values from 1 to 1000, moreover, the higher it is, the more harm this defect (refusal) can bring. The resulting estimate is compare with the limit value adopted at the enterprise priority risk ratio. If she is bigger than him, it means that this design and/or technology must be further developing.
2.
The second “whale” is a special structure of work on the project, which is carry out a “cross-functional” team. This team must consist of heterogeneous specialists. Figure 3 shows an example of the composition of such Command. Such teams work by the method of “brainstorming” 3-6 hours a day in rooms and conditions as conducive as possible to creative Activities. In cases where the design and technology are inseparable (e.g. in the production of tires), a single FMEA is created – a team that immediately considers both the design and the production process of the product.
3.
The third “whale” – the requirement of high professional qualification of all members of the FMEA team, having considerable practical experience with similar products and technology in the past.
In light of liability for the quality of the products, this method determines the technical level of the products with from the point of view of error prevention, that is, the identification of potential errors and assessment of the severity of the consequences for the customer (external party), as well as the elimination of errors or a decrease in the degree of their impact on quality (conclusions for internal Party).
Design analysis is based on theoretical knowledge and information about experience. The analysis takes place in parallel with the development process itself, gives it’s a documented form. It sort of summarizes all the searches and reasoning in the development process. Reducing the risk of errors that cause dissatisfaction of the consumer and loss of interest in the products, is an essential element for maintaining competitiveness.