Where FMEA only offers qualitative information, FMECA offers both qualitative and quantitative information, allowing users to measure a level of criticality to failure modes and order them according to importance. FMECA is usually conducted either with a top-down or a bottom-up approach.
FMECA is a technique used to identify, prioritize, and eliminate potential failures from the system, design or process before they reach the customer. they occur.” Initially, the FMECA was called FMEA (Failure modes and e ects analysis)
Failure Modes and Effects Analysis (FMEA) is a systematic, proactive method for evaluating a process to identify where and how it might fail and to assess the relative impact of different failures, in order to identify the parts of the process that are most in need of change.
The 7 steps in the FMEA AIAG & VDA structure
Planning and Preparation.
Structure Analysis.
Function Analysis.
Failure Analysis.
Risk Analysis.
Optimization.
Results Documentation.
FMEA is the quintessential Six Sigma tool. It helps decrease defects while increasing customer satisfaction.
Here’s an overview of the 10 steps to a Process FMEA.-
STEP 1: Review the process.
STEP 2: Brainstorm potential failure modes.
STEP 3: List potential effects of each failure.
STEP 4: Assign Severity rankings.
STEP 5: Assign Occurrence rankings.
STEP 6: Assign Detection rankings.
STEP 7: Calculate the RPN.
Types of FMEA:
Process FMEA (PFMEA) Functional FMEA (FFMEA) / System FMEA (SFMEA).
FMEA is employed during the Analyze phase of the Six Sigma DMAIC cycle. It can help project teams identify product features and process tasks that are more prone to defects and failure.
A Failure Mode and Effects Analysis (FMEA) is a generally valid analytical method in quality management and is considered standard in many companies today. It is used to find potential errors in products before they occur. Appropriate actions are then implemented to prevent these potential errors from occurring.
RPN in FMEA?
Formula: The Risk Priority Number, or RPN, is a numeric assessment of risk assigned to a process, or steps in a process, as part of Failure Modes and Effects Analysis (FMEA), in which a team assigns each failure mode numeric values that quantify likelihood of occurrence, likelihood of detection, and severity of impact.
Companies across various industries use methodologies like FMECA and FMEA to identify and analyze the failure modes for a process or product. The acronym FMECA stands for failure mode, effects and criticality analysis, while FMEA is short for failure mode and effects analysis. Even though these methods share similarities, they are not one and the same. As a business owner, it’s important to understand the differences between the two so you can implement them in your organization.
Failure mode and effects analysis has been around since the 1940s. Today, this method is widely used in the space, aircraft and electronic industries. Its role is to identify potential problems that may occur in the manufacturing, assembly and design processes. Basically, it helps detect errors or failures that may affect a product’s quality.
During this process, the FMEA team will sort the risks from highest to lowest through an RPN risk analysis. The RPN (risk priority number) helps estimate the likelihood of failure, its severity and the effectiveness of corrective actions. It is calculated by multiplying these three variables.
The information provided by this method helps determine the impact of a potential failure on products or processes. Furthermore, FMEA experts rank each failure based on its impact and its probability of occurrence. Businesses can use this data to develop better products by improving their design and key features.
This type of qualitative analysis is typically used both at the design and control stages. Most companies use it when they are launching new products or adding new features to existing products. If a product or process doesn’t work as it should, you may use this method to determine the cause of failure.
the role of fmeca
FMECA, which stands for failure mode, effects and criticality analysis, takes this process one step further. Each failure mode is assigned a severity level. The FMECA team will not only identify but also investigate potential failure modes and their causes.
Compared to FMEA, this method looks at potential problems in more detail and yields more accurate results. When done right, it helps identify those errors with the highest criticality number based on their likelihood and severity.
FMEA provides detailed insights about each product or process, factoring in its safety, health hazards, environmental impact and other aspects. For example, a failure that may lead to death will be classified as catastrophic. One that may result in minor system damage or minor injury will be categorized as marginal. If it’s likely to cause major system damage or severe injuries, it will be considered critical.
After identifying and locating a potential failure, the FMECA team will isolate it through a series of actions. Therefore, in order to apply this method, it’s necessary to first perform FMEA. These processes are interconnected and complement each other, allowing for a more robust analysis.
applications for fmea and fmeca
Today’s customers are more demanding than ever before. They expect to get products that are safe, functional and efficient. Both FMEA and FMECA can help you meet their expectations by delivering quality goods and services. A health care facility, for example, can perform FMEA and FMECA on tomographs and ultrasound devices. A bank can use these methods to identify flaws in its ATM machines.
These methodologies contribute to improved designs for a wide range of products, leading to higher quality, increased reliability and enhanced safety. They can also reduce the costs associated with product development and help you avoid expensive lawsuits.
Additionally, they provide the information you need to ensure that your products meet the highest quality and safety standards, such as Six Sigma, PSM and ISO 9001. Depending on your industry, you may use these methods to carry design, manufacturing, development and other activities that are critical to your business.
FMECA can be conducted based on the following approaches:
Top-Down Approach – System Level / Sub System Level
The top-down approach is mainly used in an early design phase before the whole system structure is decided and the analysis is usually function-oriented. The analysis starts with the main system functions, and how these may fail. Functional failures with significant effects are usually prioritised in the analysis, however, the analysis will not necessarily be complete. The top-down approach may also be used on an existing system to focus on problem areas.
Bottom-Up Approach – Component Level
The bottom-up approach is used when a system concept has been decided. Each component on the lowest level of indenture is studied one-by-one. The analysis is complete once all components are considered.
The Criticality Analysis (CA) can be performed using either a quantitative or a qualitative approach. Availability of part configuration and failure rate data will determine the analysis approach.
As a general rule:
• use a Quantitative approach when actual component data is available;
and
• use a Qualitative approach when no actual component data or only generic component data is available.
The results of the Criticality Analysis will result in either a defined value (Quantitative), where Failure Mode Criticality (CM) is calculated as:
