FMEA – AVOIDING FAILURES BEFORE THEY OCCUR

FMEA – all information comprehensively summarized:

• FMEA definition
• Historical development
• FMEA types
• FMEA implementation
• FMEA software as a comprehensive tool
• Systematic identification of potential failures
• Risk evaluation based on previous FMEAs
• Implementation and documentation support
• What you need to be aware of when performing FMEA
• Costs and benefits of FMEA

FMEA DEFINITION
FMEA stands for Failure Mode and Effects Analysis. In the quality management area, FMEA is a standardized method of avoiding failures in your products and processes. Potential failure causes are analyzed and respective failure avoidance strategies developed whilst a product or process is still in the development phase. Dealing with potential causes of failures at an early stage lets you avoid the high costs or losses that might otherwise occur as a result of these failures. The later an failure is discovered in the product’s life cycle, the more complex and expensive it will be to eliminate it. In addition, FMEA uses the knowledge gained to avoid repeating the failures and for lessons learned purposes.

HISTORICAL DEVELOPMENT
The FMEA story began at the end of the 1940s when the US military published its MIL P 1629 procedure . In the 1960s, this was used by NASA as a basis for developing their FMEA for the Apollo project. In the mid-1970s, the automobile manufacturers Ford, Chrysler and GM each introduced their own FMEAs – making these mandatory for their suppliers, whereby they established the distinction between design and process FMEA. At the beginning of the 1980s, these three major US car manufacturers went on to introduce a standardized FMEA – entitled QS-9000-FMEA – based on an initiative of their suppliers. Ford’s FMEA system was used as a basis which was then supplemented by the specific requirements of the other two manufacturers. In 1996, the German Association of the Automotive Industry (VDA) published a revised FMEA system. Finally, in June 2019, the VDA and the US American AIAG (Automotive Industry Action Group) published a joint FMEA standard that harmonizes the two FMEA families for the automotive industry.

FMEA TYPES
The VDA distinguishes between two types of FMEA: The analysis of product functionality with regard to potential failures during the product design phase (Design FMEA) and the analysis of the individual process steps (Process FMEA).

• Design FMEA (D-FMEA)
  If DFMEA is conducted as a system DFMEA, the interfaces and interaction between the various systems, subsystems, environment, reseller (suppliers (Tier N), OEMs) and the end users are analyzed in a block/boundary diagram. In a component DFMEA, only one subsystem, resp. one part of the system DFMEA, is examined. In addition, DFMEA can also be used to detect failures in machines or tools. Depending on one’s viewpoint, system FMEA and component, resp. product FMEA, may be listed as independent FMEA types.
• Process FMEA (P-FMEA)
  Process FMEA examines the extent to which failures that occur during manufacturing, assembly or logistical processes may lead to the product no longer meeting the design or customer specifications.
  

FMEA IMPLEMENTATION
An FMEA is carried out by a team consisting of employees from different departments and is led by an experienced FMEA moderator.

An FMEA is usually divided into seven steps:

1. Planning and preparation
2. Structure analysis
3. Function analysis
4. Failure analysis
5. Risk analysis
6. Optimization
7. Results documentation

STEP 1: PLANNING AND PREPARATION
To start off, the framework conditions for performing the FMEA are defined. According to the harmonized AIAG/VDA FMEA Handbook, these include the “5Ts”:

• InTent/goals
• Composition of the Team
• Timing/milestones
• Determining FMEA Tools and FMEA methods and
• Assigning Tasks.

These 5Ts are supplemented by the lessons learned from previous FMEAs. In this process step, the FMEA team also determines the depth of observation and tracks down all the interfaces right up to the end user.

STEP 2: STRUCTURE ANALYSIS
Structure analysis visualizes the design of the product or process by means of construction/design FMEA or process FMEA. This makes the scope and depth of the analysis visible. A hierarchical classification results – depending on the defined system elements.

STEP 3: FUNCTION ANALYSIS
The third step allocates functions to the respective system elements. These are based on the requirements, existing specifications and empirical values. These functions are then divided up according to subsystem, assembly and component, resp. process, process step and influencing factor.

STEP 4: FAILURE ANALYSIS
The aim of performing failure analysis is to clearly identify and correlate the failure effects, failure modes and failure causes. This results in a failure chain which can be used to identify the risks contained in a process and the respective effects on the product or end customer.

STEP 5: RISK ANALYSIS
After failure analysis has been completed, risk evaluation, resp. risk analysis and an analysis of the respective actions, is performed. This is aimed at identifying and prioritizing the risks involved, with a focus on the following targets:

• Assigning current prevention and detection actions
• Evaluating each individual failure chain in terms of its severity, occurrence and detection
• Evaluating failure chains and determining action priority
• Cooperation between the customer and the supplier (severity)

STEP 6: OPTIMIZATION
During the optimization process, further actions and proposed solutions are identified with the aim of avoiding potential risks, resp. increasing the probability of their detection. The optimization process continues until all the risks are at an acceptable level.

STEP 7: RESULTS DOCUMENTATION
Finally, the planning process and results of the FMEA are documented. This documentation is intended to:

• Depict the results and conclusions
• Document the risk analysis
• List the risk reduction actions
• Document the effectiveness of these actions
• Evaluate the risk following implementation

FMEA SOFTWARE AS A COMPREHENSIVE TOOL
As already mentioned above, FMEA is always performed by an interdisciplinary team – with employees from different departments and under the leadership of a moderator. For every single FMEA, continuity is crucial to success. In FMEA practice, there is always the risk of certain aspects being overlooked, if the participants do not work together in a meticulous and transparent manner.

Special FMEA software, therefore, is an important aid when implementing FMEA. Your FMEA tool must be centrally accessible to both your FMEA moderator and all in-house participants.

FMEA software, for example CASQ-it FMEA supplied by Böhme & Weihs, supports the participants throughout the entire FMEA process. When structure analysis is performed, our FMEA tool provides tree structures that help to create an overview, whilst graphical system networks visualize the product design and the process chain. Self-learning catalogs automatically suggest the appropriate terminology. This creates a comprehensive knowledge database which allows you to perform further FMEAs more and more quickly.

SYSTEMATIC IDENTIFICATION OF POTENTIAL FAILURES
Our FMEA software systematically identifies and establishes links between potential failure causes, the effects of these failures and their interdependencies. This results in complete failure chains which are displayed in clearly structured networks. In the case of a complaint, you can immediately see which possible resulting effects might need to be reckoned with.

Information on failure modes, causes and effects are directly entered in standard-compliant form sheets, such as our FMEA form. Our CASQ-it software provides an evaluation of the functional and malfunctional interrelationships in the shape of a catalog. The malfunction networks provide graphical support during the cause analysis process.

RISK EVALUATION BASED ON PREVIOUS FMEAS
The multilingual, catalog-controlled error failure mode selection feature helps the FMEA team to determine the necessary actions. Through these catalogs, suitable terminology is proposed based on that already used in earlier FMEAs. This means that existing knowledge is also used efficiently during this process. When conducting risk evaluation, the users can choose between standard-compliant evaluation schemes and your company’s own evaluation system.

Thanks to the clearly structured risk evaluation process, our FMEA software directs your attention straight to areas where there is a need to act and introduce optimization actions. The software creates a personal to-do list with open actions for each individual employee.

IMPLEMENTATION AND DOCUMENTATION SUPPORT
The FMEA moderator receives additional support from our FMEA software. All statuses are continuously updated, whereby the moderator can directly access all the information at all times. In the case of a postponement, the FMEA moderator is notified immediately via email.

CASQ-it FMEA creates your risk analysis documentation either in compliance with the VDA/AIAG standards or according to your own formats. Report bundling, process workflow diagrams in your Control Plan, comparative analysis and action overviews bring transparency to your risk management procedures. Your results are processed seamlessly by CASQ-it – right up until the successful completion of your product development process. Your FMEA system achieves this by supplying the individual process steps for your Control Plan , including detailed test plans.

The final documentation is supported by the FMEA software to ensure that the most important changes are traceable, that action overviews are generated, and that forms and risk overviews are accordingly created.

WHAT YOU NEED TO BE AWARE OF WHEN PERFORMING FMEA
In addition to the standard or organization-specific requirements pertaining to performing an FMEA, typical human errors also need to be considered. These often arise from everyday operations and are frequently overlooked. For example, when employees play down criticism of their developments, or where there is a fear of creating a bad atmosphere between colleagues when a mistake is discovered, or if the team members have simply not been trained well enough in FMEA methodology. Therefore, right from starting to plan an FMEA, the moderator should talk to his/her team about the following points and ensure that these points are accordingly observed:

• Employees should be sufficiently trained in FMEA methodology
• The essential functions of an object should be concentrated on
• The FMEA should not be performed merely superficially
• The confidentiality agreement between the parties should be observed
• Failures should be evaluated objectively and realistically
• Criticism of one’s own developments should be allowed
• There should be no negative consequences for anyone who has discovered an failure

COSTS AND BENEFITS OF FMEA
When first introducing FMEA methodology, the effort involved in the FMEA process initially appears to exceed the benefits. A team of employees is tied up with this project – with numerous working hours spent dealing with the failures of a product that does not yet even exist in reality. On top of this, motivating employees to demonstrate potential failures in their own designs requires the leadership skills of an experienced team leader with a great knowledge of human nature.

So, where are the benefits and ROI of FMEA to be found? When introducing the FMEA method, the expenditure might really exceed the benefits initially. A project is caused to slow down and your employees are tied up. However, the procedure will become routine over time. The employees who are involved in the FMEAs will learn how to use your FMEA software and tools and gain an insight into the project that goes way beyond their original view of their respective areas of responsibility. It will become increasingly easier and quicker to identify failure causes. Every failure cause identified and eliminated in advance cuts out costs to the company that would otherwise be incurred through reworking products, resolving complaints or even awarding compensation. Extrapolated on the basis of the number of products in circulation, even your very first conscientiously performed FMEA will pay itself off.
If a follow-up product is developed, the new FMEA team will be able to draw on the results and experience gained from the previous FMEAs. Failure causes can be found more quickly and corrective actions – modelled on earlier FMEAs – taken much faster – with a hugely reduced amount of effort required.

Therefore, no company should shy away from performing FMEA analysis using the apparently high level of initial effort as an excuse. The introduction of FMEA will result in lower complaint-handling costs, a higher level of customer satisfaction and a generally more reliable product.

If you have any questions on how to implement a software solution for performing professional FMEA analysis at your company, or if you need training or courses on using our CASQ-it FMEA solution, please contact us.