In the manufacturing industry, maintaining high product quality standards is a key driver of success that ultimately translates into satisfied customers. That said, the highest product standards can only be achieved if defects and errors can be identified and analyzed even before they occur. For a great many companies, the “failure mode and effects analysis”, FMEA for short, has established itself as an indispensable quality management method.
What is the FMEA method?
Failure mode and effects analysis is a method of detecting sources of error before errors occur, identifying their triggers and consequences, and analyzing them. The resulting data can in turn be used to determine the appropriate preventative actions to be taken. FMEA is used primarily during the development process for new products (design FMEA) or processes (process FMEA) or when making adaptations to products or processes.
The FMEA method’s chief areas of application are in the automotive and aerospace industries, where the method is used primarily in connection with developing technical products.
The method bears some significant similarities with the 8D problem-solving method, which is also included under the umbrella of quality management. Both procedures involve people working together in interdisciplinary teams, investigating the root causes of errors, and then deriving corrective actions. What differentiates the two approaches fundamentally, however, is the fact that FMEA works preventively; that is, it deals with potential defects, while the 8D method addresses problems that have already occurred.
What are the advantages of the FMEA method?
1. Significant cost savings and greater customer satisfaction
Performing a comprehensive failure mode and effects analysis at an early stage enables the responsible personnel to identify and prevent any damage to the product or in the manufacturing process before it occurs. At the same time, it reduces the likelihood of errors occurring at a later date, when they are far costlier. As a consequence, companies can slash costs while boosting customer satisfaction over the long term.
2. Assuring lasting corporate success
When it’s a customer – rather than the manufacturer itself – who discovers a defect first, the company’s reputation can receive a damaging blow. Implementing the FMEA method goes a long way toward preventing that scenario from occurring.
3. Increased product quality
Failure mode and effects analysis identifies and rectifies errors as early as the design phase. This translates into dramatically enhanced product quality coupled with a reduction in product recalls.
4. Greater transparency in quality management
Using standardized FMEA spreadsheets and forms or FMEA software creates a consistent, transparent, and understandable picture of any product weaknesses. Additionally, FMEA encourages information sharing across departments, which in turn raises quality awareness among the staff.
How does FMEA work?
By harmonizing the FMEA method, the AIAG (Automotive Industry Action Group) and the VDA (Verband der Automobilindustrie – German Association of the Automotive Industry) succeeded in creating a globally uniform standard. The guideline provides a systematic approach based on the following seven steps:
Step 1: Project planning and preparation (scoping)
The first step is to establish the team, define the objective and the scope of consideration, and plan the project. The five T’s serve as a guide to achieving optimal results:
- Target: Why do we need an FMEA?
- Timing: By when should the FMEA be executed?
- Team members: Who are the people that make up the team?
- Task allocation: What tasks need to be completed?
- Tools: What tools are used to perform the analysis?
Step 2: Structural analysis
During structural analysis, the FMEA team visualizes the scopes that were defined in the first step and depicts them visually. In doing so, the team breaks down the objects under examination conceptually into their individual parts and arranges them in a structure tree for greater overview.
Step 3: Functional analysis
The objective at this stage is to establish an understanding of the product or process under investigation. Requirements, empirical data, and specifications can be leveraged to derive and visualize the functions of the system elements or workflows under consideration.
Step 4: Error analysis
In this step, the team identifies potential defects for each function and correlates them to the structure. This establishes correlations among errors – causes – consequences. By the conclusion of this phase, all problems, their triggers, and their consequences should be graphically depicted from end to end.
Step 5: Risk assessment
Based on the error analysis, the relevant staff evaluate the probability of occurrence and detection as well as the impact of the particular defect or root cause. The task priority (high, medium, low) is based on these factors. The risk assessment serves as the starting point for error prevention measures and ultimately for product or process optimization, and replaces the previous risk priority number (RPN) in the FMEA as harmonized according to AIAG and VDA.
Step 6: Optimization
Based on the previously identified task priorities, the team identifies potential solutions for reducing the risks and then performs another assessment. This optimization process is repeated until all risks are at an acceptable level.
Step 7: Documentation
At the conclusion of an FMEA project, the project team documents the results and the process. The documentation contains all of the decisions made, as well as critical errors, their causes, and specific risks.
By documenting FMEA in this way, a company establishes a knowledge base that is logged and that supports ongoing and future development projects.
Why is using FMEA software a worthwhile option?
A lot of companies use common spreadsheet programs such as Microsoft Excel to prepare an FMEA. But manual data entry renders the process extremely time-consuming. What’s more, these types of programs make it difficult to reuse or repurpose the information, for instance as part of a quality control plan or for version management.
Consequently, when it comes to digitalizing critical data and the associated workflows, using dedicated FMEA software is certainly a good idea. By providing prefabricated modules, it allows users to automate the creation process to a large extent and to assign pending tasks directly to both in-house and external staff.
Integrating FMEA into a cloud-based CAQ system such as Fabasoft Approve generates powerful synergies between inspection planning and response and complaint management. In the event of a complaint, companies have the option to access the digital FMEA whenever they want. This makes it easy to verify whether the specific problem is already covered by the software and, where necessary, to add it. A solution of this kind eliminates needless repetitive errors and makes it possible to apply existing knowledge to the development of new products.
FMEA software augments the quality management expertise considerably and is instrumental in helping companies produce high-quality products. By implementing a cloud-based CAQ system, members of the FMEA team and the technical departments obtain a thorough overview of any defects at any time and can respond with appropriate countermeasures. In addition, thanks to versioning, all the changes are transparent and traceable for everyone involved.