Lean Six Sigma Green Belt Certification FMEA

FMEA is a proactive tool to prevent mistakes and errors in the processes and design. When you are doing something for the first time and don’t have enough data to quantify the risks of failure, FMEA can be used. Risk management is the process of identifying, assessing, and controlling threats to an organization’s capital and earnings. Risk reduction or “optimization” involves reducing the severity of the loss or the likelihood of the loss from occurring. FMEA serves this purpose. FMEA 6 Sigma is a tricky topic and needs concentration. Read this article to understand everything about FMEA. A video on our website is also available explaining the tool.

Read this blog to understand topics like severity ranking, potential causes, prevention controls, testing, detection controls, and a lot more. The tips below are specially designed by industry experts with 30 years of experience. Read the blog carefully to grab a deep insight on FMEA.

FMEA in Lean Six Sigma

Full form of FMEA in Six Sigma is Failure Mode and Effects Analysis. It stands out as a crucial tool for risk management and process improvement. By combining the principles of Lean and Six Sigma with the FMEA methodology, organizations can effectively identify and mitigate highly hazardous failure modes. This approach enables teams to prioritize their efforts and resources toward addressing critical failure modes that could significantly impact operations, customer satisfaction, or regulatory compliance. 

Purpose of FMEA in Six Sigma is as a robust control and preventive measures to minimize the occurrence and impact of highly hazardous failure modes. This proactive approach not only enhances operational efficiency and quality but also ensures the safety and well-being of employees, customers, and the environment. FMEA stands for in Six Sigma as sustainable improvements while fostering a culture of continuous improvement and risk prevention.

FMEA – How to solve & tips

There are a total number of 12 tips to complete FMEA Lean Six Sigma correctly. These tips were created by experts and they are as follows

• Developed in the 1950s, FMEA was one of the earliest structured reliability improvement methods. Today it is still a highly effective method of lowering the possibility of failure. Failure Mode and Effects Analysis (FMEA) is a structured approach to discovering potential failures that may exist within the design of a product or process. Failure modes are the ways in which a process can fail.
• Effects are ways in which these failures can lead to waste, defects or harmful outcomes for the customer. Failure Mode and Effects Analysis is designed to identify, priorities and limit these failure modes.
• FMEA is not a substitute for good engineering, rather it enhances good engineering by applying the knowledge and experience of a Cross Functional Team (CFT) to review the design progress of a product or process by assessing its risk of failure. One can say that it is a systematic method for identifying possible failures that pose the greatest overall risk for a process, product, or service which could include failures in design, manufacturing or assembly lines.
• FMEA is classified into Design FMEA (DFMEA) and Process FMEA (PFMEA).
• Design FMEA (DFMEA) is a methodology used to analyze risks associated with a new, updated or modified product design and explores the possibility of product/design malfunctions, reduced product life, and safety and regulatory concerns/effects on the customer.
• They are derived from: material properties (Strength, Lubricity, Viscosity, Elasticity, Plasticity, Malleability, Machinability etc.), geometry of the Product (Shape, Position, Flatness, Parallelism, tolerances/stack-ups, interfaces with other Components and/or Systems (Physical Attachment/Clearance; Energy Transfers; Material Exchange or Flow i.e. Gas/Liquid; Data Exchanges – Commands, Signals, Timings), and engineering Noise including User Profile, Environments, Systems Interactions & Degradation.
• Process FMEA (PFMEA) is a methodology used to discover risks associated with process changes including failure that impacts product quality, reduced reliability of the process, customer dissatisfaction, and safety or environmental hazards.
• They are derived from the 6Ms, man: human factors/ Error, methods: methods involved in processes of product/service including assembly lines, supply chains and communications standards, materials: materials used in the process, machinery: machines utilized to do the work, measurement: measurement systems and impact on acceptance, and mother earth: Environment Factors on process performance.
• FMEA is one of many tools used to discover failure at its earliest possible point in product or process design. Discovering a failure early in Product Development (PD) using FMEA provides various benefits.
• Multiple choices for mitigating the risk, higher capability of verification and validation of changes, collaboration between design of the product and process, improved design for manufacturing and assembly (DFM/A), lower cost solutions, tribal knowledge, and Standard work utilization are some of the benefits of FMEA.
• Ultimately, this methodology is effective at identifying and correcting process failures early on so that you can avoid the nasty consequences of poor performance.
• FMEA provides a structured approach to identifying and prioritizing potential failure modes, taking action to prevent and detect failure modes and making sure mechanisms are in place to ensure ongoing process control. FMEA also helps document and identify where in a process lies the source of the failure that impacts a customer’s CTQ’s.

In the world of Six Sigma, the FMEA Six Sigma template plays a vital role in identifying and mitigating potential risks. This template is a structured approach to analyzing failure modes, their causes, and their potential impact. By utilizing the FMEA template, organizations can proactively address weaknesses, optimize processes, and enhance overall product quality. From brainstorming potential failure modes to implementing preventive actions, the FMEA Six Sigma template provides a systematic framework for continuous improvement.

How can FMEA be used?

Target a bottle neck and focus on a failure mode the team needs to eliminate. Once each failure mode is identified, the data is analyzed, and three factors are quantified:

• Severity (SEV): The severity of the effect of the failure as felt by the customer (internal or external). The question may be asked, “How significant is the impact of the effect on the customer?” Severity of 1 denotes low risk to the end customer, and a score of 10 denotes high risk to the customer.
• Occurrence (OCC): The frequency at which each failure or potential cause of the failure occurs. The question may be asked, “How likely is the cause of the failure mode to occur?” Occurrence of 1 denotes low probability of the risk happening, and a 10 denotes a very high probability of the risk happening.
• Detection (DET): The chance that the failure will be detected before it affects the customer internal or external). The question may be asked, “How likely will the current system detect the failure mode if it occurs, or when the cause is present?” Detection of 1 denotes a process that WILL likely catch a failure, and a 10 means the process will likely NOT catch a failure.

FMEA and DMAIC in Lean Six Sigma

FMEA and DMAIC (Define, Measure, Analyze, Improve, Control) are two fundamental methodologies in the realm of process improvement. FMEA, a proactive risk assessment tool, helps identify potential failure modes and their impact, while DMAIC provides a structured approach for problem-solving and process optimization. Integrating FMEA within the DMAIC framework ensures a comprehensive analysis of failure modes throughout the improvement journey, enabling organizations to identify critical areas for intervention and implement effective control measures. By combining the power of DMAIC and FMEA, organizations can drive continuous improvement, mitigate risks, and achieve enhanced operational excellence.

Can FMEA be used outside of Six Sigma?

While FMEA is commonly associated with the Six Sigma methodology, its applications extend beyond this framework. FMEA is a powerful risk assessment tool that can be employed in various industries and domains to identify and mitigate potential failures or risks proactively. It is widely used in engineering, manufacturing, healthcare, software development, and even project management. By systematically analyzing failure modes, their causes, and the impact they may have, organizations can implement preventive measures to enhance product quality, safety, and overall process efficiency. FMEA’s versatility and ability to foster continuous improvement make it a valuable technique applicable to any industry striving for excellence in risk management and quality assurance.

FMEA in Lean Six Sigma- Example

FMEA Six Sigma example below can help us understand FMEA better. Let us understand with the example below:

Each of the three factors is scored on a 1 (Best) to 10 (Worst) scale. The combined impact of these three factors is the Risk Priority Number (RPN). This is the calculation of risk of a particular failure mode. The information inputted into an FMEA is calculated, and the output is a Risk Priority Number (RPN). The RPN is calculated by multiplying the severity times the occurrence times the detection (RPN = Severity x Occurrence x Detection) of each recognized failure mode. With the table given below you can get a better idea about it.

Failure Modes	Severity (1-10)	Occurrence (1-10)	Detection (1-10)	RPN
A	2	4	10	80
B	3	8	2	48
C	9	2	1	18

FMEA link: https://anexas.net/failure-modes-and-effects-analysis-lean-six-sigma/

Also read: Lean Six Sigma Green Belt Certification Control Charts

FMEA- Example exercise 1

RPN in FMEA stands for

FMEA- Example exercise 2

Which Six Sigma tool uses RPN?

FMEA- Example exercise 3

If severity =5, Occurrence = 4, Detectability = 2, what is RPN?

FMEA- Example exercise 4

_ is the probability of the failure being detected before the impact of the failure to the process

Answers for skills building exercises

Answer for the first sample exercise is : FMEA RPN (Risk Priority Number) is a numerical assessment of the risk priority level of a failure mode in an FMEA analysis. FMEA RPN helps the responsible team/individual to prioritize risks and make the decision on the corrective actions.

Answer for the second sample exercise is : FMEA RPN (Risk Priority Number) is a numerical assessment of the risk priority level of a failure mode in an FMEA analysis.

Answer for the third sample exercise is : Risk Priority Number = Severity x Occurrence x Detection.

Answer for the fourth sample exercise is : Detectability is often defined as the ability to detect a failure before it causes harm.