Failure Mode and Effects Analysis (FMEA) is used for failure prevention, to avoid failures in products or processes before they occur, instead of laboriously correcting them afterwards. For this reason, FMEA should be used in every company, and at a very early stage of the product development process.
Classically, an Excel spreadsheet is usually used for FMEA creation, but the modern form of the digitalized FMEA can considerably simplify many previous work processes. In this blog article, you will learn how to create an FMEA systematically and efficiently, and what advantages software-based FMEA has over the classic method.
We will also show you how a digital FMEA can be structured and how it can be used optimally using various screenshots of the iqs FMEA software.
1. Scoping – identification and definition of the project
First, determine what should be considered in the FMEA. This can be a product, a component, a process, or an interface between components (e.g. Be in the case of bolting, press-fitting or welding). Below is a list of possible occasions for an FMEA:
- New development of a product
- Product change
- Analysis of complex manufacturing processes
- Hazard analysis of safety-relevant products or processes
- Use of new machines and equipment
- Analysis of processes and products with high environmental risk or risks for occupational health and safety
- Analysis of changed operating conditions at the customer
Through this first step in the harmonized FMEA methodology, the process or product is delineated and described. You determine what specifically should be considered and analyzed. This then results in the project order, in which you define the starting point, the analysis limits and the 5Z (purpose, timing, composition of the team, assignment of tasks, WerkZeuge).
Advantages of FMEA software:
You can directly set the team members and their responsibilities in the software. In the event of a change, they then receive an action to adjust the FMEA. Action tracking is straightforward and possible at any time.
2. Description of the system structure
In the structural analysis, you first document all elements relevant to your FMEA: In the case of the P-FMEA (process FMEA), these are the processes to be considered chronologically to the corresponding production order. In the D-FMEA (design or construction FMEA) it is the part to be considered and its components.
The interfaces are also documented in this step – this applies to both the D-FMEA and the P-FMEA.
Tip: In the P-FMEA the processes always form the focus level, i.e. the main level of consideration (also often referred to as the failure level). In the D-FMEA, the focus level is determined by the part or the process. its components and their connections are formed.
Advantages of the FMEA software:
The available blocks and the auto-completion simplify the creation of the FMEA. The adopted building blocks can be adapted to a specific project at any time. For a better overview and a simplified creation, maintenance and editing you can choose from different representations.
3. Determine the functionality
During the functional analysis, it is recorded what the product exists for and which primary functions (D-FMEA) it must have or. which specifications are to be produced (P-FMEA). For this purpose, the individual functions, specifications and requirements are examined and listed.
In the D-FMEA, the functions are linked and visualized with the help of a function network. You get a graphical support to quickly and easily see by which interrelationships of the sub-functions the main function is ensured, respectively. which characteristics have been dimensioned for which function.
In the P-FMEA, the function network plays a very subordinate role at best.
Advantages of the FMEA software:
Drawing integrations make it easy to transfer specifications (characteristics) into the FMEA by selecting the relevant characteristics from the total scope. Since all features are displayed, nothing can be forgotten and no transcription errors occur.
The interrelationships between the functions can be clearly represented in the function network. In this way, everyone knows during the process which point is at issue and at which analysis step the team is currently located. This means that you always have an exact overview of the current status of the FMEA.
4. Analyze possible defects
Failure analysis is about uncovering and describing potential failures, damages and hazards of each function.
It is important to describe the defects briefly but precisely. Consider also improbably occurring problems, defects with small effect or problems, which occur only under certain conditions resp. arise at certain stages of production.
Example: The designation "Diameter not in order" is not clear enough and an error prevention or. -detection therefore not possible. Better would be "Diameter too small" or "Diameter too large". These statements are clear and the need for action can be derived from them.
advantage of the FMEA software:
By systematically recording errors, error sequences, causes and their links in the error network, the team quickly sees where the focus of errors and thus the need for action lies.
The software-based FMEA evolves with your products or processes. So you can e.g. B. In a database-based CAQ system, in the event of a complaint, access the FMEA and compare whether the problem that has occurred has already been identified. If not, this can be supplemented. If it has already been described, you can check whether corresponding measures have been defined or whether they still have to be defined, if necessary.
5. Risk analysis to prevent defects
Now that you have linked all possible errors as consequences-error-causes, an initial risk assessment is carried out (previously as RPN, today as task priority AP).
For each "error-consequence-cause chain", preventive and detective measures are documented, which reflect the current state of the process. Map initial state. This results in the evaluation criteria for the probability of occurrence and detection of defect-cause combinations.
Advantage of the FMEA software:
For similar products and processes, you can fall back on already created modules and inherit them. Thus, you can take over already created characteristics and adapt them accordingly without having to start from scratch. This means that existing experience is not only reused, but also further developed.
6. Optimization through action planning
In this step, all measures are checked for their optimization potential. It makes sense to first work on the errors that harbor a high hazard potential or safety risk.
Previously, the RPN (risk priority number) was used here. However, due to the harmonization of AIAG and VDA, the AP (task priority) is now used.
The planning and implementation of the measures takes place within the framework of the FMEA. Other or additional persons outside of the team can also be involved in the measures. During implementation, it is checked whether the improvements and objectives pursued with the measure are achieved.
Advantages of the FMEA software:
With a database-based CAQ system, all actions can be tracked centrally. Versioning also means that changes can be tracked at any time.
Another advantage is that each employee has only one to-do list for all measures. For comparison, when using Excel, a team member may be mentioned in 25 files to complete a task.
7. Documentation of the results
After the FMEA project is completed, the team leader records the results of the FMEA process and documents them for the company, other FMEA teams, and departments (e.g. development, production, product management). By documenting FMEA results, the company gains a logged knowledge base to better support current and future development projects. If you regularly carry out FMEA projects in this way, a corresponding quality culture can develop in your company.
Advantage of the software:
In a database-driven CAQ system, the FMEA is a living document. It represents a knowledge repository of the company, which is constantly being further developed. Through the integration of complaint management, process and product audit, the knowledge repository receives additional new input.
Conclusion on the advantages of a digital FMEA
The seven steps of an FMEA are always the same, regardless of which system you are working with. In every step, however, the advantages of software are clear: many work processes (e.g. B. Inputs, assignments, etc.) are simplified and can be carried out more quickly as a result. A central database provides a good overall view and all parties involved can see the current status at any time. The clear documentation creates a valuable knowledge store that helps your company to further develop and optimize the following FMEA projects.