What is FMEA Analysis?

You might have heard about product recalls from even top brands. These recalls are the result of poorly designed products or can also arise due to poor processes. These failures are generally discussed in the public forum with suppliers, service providers, and particularly manufacturers. Many critical evaluations are done on the product to determine the brand's inefficiency in producing a safe product. Is it possible for manufacturing units to assess these failures in advance? Yes, it is possible with Failure Mode and Effects Analysis. 

FMEA analysis – The Meaning:

When hearing about the term FMEA analysis for the first time, you will naturally ask what FMEA Analysis is. This is the short form for Failure Mode & Effect Analysis. It is nothing but a technique aimed at permitting organizations to judge failure in advance. This technique allows manufacturing units to judge failure right in the designing stage itself. It helps manufacturing units judge not a single but all the probable failures in a production or design process. 

You now know what is FMEA Analysis. But you should be interested in knowing when it was discovered. It was developed in the 1950s, and from then on, it steadily gained popularity among manufacturing units through the structured dependability and improvement technique. Today, it continues to gain popularity as a highly effective technique to reduce the chances of failure.

Detailed Meaning:

You know that FMEA is called a technique together. However, this term can be split into two. Even, when you split, they have a meaning of their own. For instance, failure modes are the methods of how a process can fail. Effects are how these failures can contribute to harmful outcomes, defects, and customer waste. So, now, you know the answer to the question of the purpose of the Failure Mode Effective Analysis. Yes, it is to identify, give importance and restrict these failures.

Two Categories of FMEA:

Now, you might think that FMEA can eliminate the need for good engineering. Nevertheless, it is not a substitute. Rather, it aids in improving good engineering by applying the experience and knowledge of the Cross-Functional Team for reviewing the design progress of a process or product by evaluating its risk of failure. FMEA is divided into a couple of broad categories. They are Design FMEA and Process FMEA. The former is referred to as DFMEA, while the latter is called PFMEA.

Design FMEA Explained:

The purpose of Design FMEA is to explore the product's chance of malfunctioning. It also evaluates the factors that can contribute to a reduction in the product's life. It even evaluates regulatory concerns derived from tolerances, material properties, interfaces with systems/components, geometry, and engineering noise.

Process FMEA:

The purpose of process FMEA is to spot failures that impact the quality of the product. It also spots customer dissatisfaction, reduced dependability and the process and atmospheric risks derived from different factors like materials used, techniques followed when processing, human factors, machinery used, atmospheric factors on process performance and measurement systems effect on acceptance.

FMEA – When To Use It?

You will be interested in finding the answer to the question of what is FMEA used for after understanding what is Failure Mode Effect Analysis. A manufacturing unit can use this analysis when:

• It is creating improvement goals
• The manufacturing unit is developing updated or new control plans.
• There is a change in the supply chain or process
• There is a transformation of service with modified, new or additional steps
• A product has a design update or new design and
• When the manufacturing unit is engaged in the development of an entirely new product.

Working of FMEA:

After identification of failure modes, you will have to engage in data analysis. In this process, three factors are to be considered with the utmost care:

1. Severity: This is the first of the three factors to consider when analyzing data. It involves the severity of the effect of failure from the customers' point of view. Here, customers include both external and internal customers. To find the severity of the effect of a product failure, it is better to talk straight to the customers. Only then, it will be possible to gain a clear understanding of how they were affected.
2. Occurrence: This denotes the interval at which the potential cause of the failure or the actual failure takes place. Here, you will have to ask yourself about the likelihood of the cause of the failure mode taking place.
3. Detection: Thirdly, detection involves the probability that the failure will be detected early. Early denotes the identification of the failure even before it affects either the internal or external customers. To identify the failure before it shows up, you will have to question the efficiency of the present system.

Finding FMEA Failure Modes:

One of the initial steps when completing FMEA is to identify the participants. The right people with the appropriate experience, like designers and process owners, should be involved when identifying failures. When these people are present, it will be easier to spot potential failure modes. You can also call upon customers and suppliers to gather alternative points of view.

Once all the participants have reached the place of discussion, the brainstorming session should begin. Together this team should identify all elements of the functions, processes, systems and components that can cause potential failure. Only when this type of move is done, it will be possible to identify the probability of failure that can prevent the product reaches the level of reliability or quality. In addition to explaining the effects of failure, this team should be able to spot the potential causes.

Steps In FMEA:

If you are answering what is FMEA in Six Sigma or what is FMEA in Quality, irrespective of the area of the process it is used, FMEA will be of great help with spotting the factors that can make a product or process a failure. If you wish to use this technique, it is better to be aware of the steps involved in FMEA:

Step 1: Identifying Potential Failures and Effects:

The initial step in FMEA is to evaluate the functional requirements. Not only functional requirements but also their effects should be identified. Only then, it will be possible to spot all failure modes. The thing to remember here is that failure mode in one element can take failure modes in other elements as well.

Once they are identified, all failure modes should be listed. This listing should be done per function in technical terms. When taking a note, the ultimate effect of each failure mode should be considered. 

Step 2: Determining Severity:

Severity involves how severe the effect of failure will be. Here, it is better to spot the effect of failure on a 1-10 scale. You have judged it right. If an effect has one as the rating, it means that it has the least severity and if an effect is given 10 as the rating, the effect will be very severe. Here, you can gain a better understanding of how to rate the effects:

Rating 10—Very high and hazardous. When an effect has this number, the product can become inoperative, thereby frustrating the customer. Based on the type of failure, there are chances of safety hazards that can even cost users their lives.

Rating 7-8 – Loss of basic functions causing dissatisfaction among users

Rating 4-6 – Moderate, making most users feel annoyed or inconvenienced.

Rating 3 - Minor, which means only a part of the system has a failure that can be identified only by a few users.

Rating 2 – Very Minor, which means that the failure can be identified only by very few users with technical knowledge.

Rating 1 – No Effect or danger. 

Step 3: Gauge Probability of Occurrence:

At this stage of FMEA, your team should evaluate the causes of each failure mode. Also, the rate at which the occurrence repeats itself should be evaluated. To do these things, you can compare similar products or processes and their documented failure modes.

At this phase, you should identify and document all causes of potential failure technically. The causes of failure are generally indicators of weaknesses in the design. Some of the examples of causes encompass incorrect algorithms. Based on the nature of the product, there can be other causes like humidity, too hot/cold operating atmosphere, excess voltage, etc. The failure modes are allocated with an occurrence ranking shortly called O. The ranking is done again from 0 to 10 as given below:

Rating 10 – Very high and the product becomes inoperative and creates dissatisfaction in customers' minds. In this case, the failure includes a safety hazard causing injury or even death.

Rating 9-10 -Failure is almost certain

Rating 7-8 – High = Repeated Failures

4-6 – Moderate failures happen occasionally

2-3 – Low with relatively few failures

1 – No documented failure on similar products

Step 4: Detection of Failure:

After remedial actions are identified, they should be tested for efficiency and effectiveness. At this stage, the design should also be verified, and inspection procedures should be specified.

At this stage, engineers evaluate the present system controls that can hinder the failure mode from progressing. Otherwise, they spot failures before they impact the customer/user. They do this by using similar techniques for spotting failures in similar systems/products.

Conclusion:

Not only what is the Failure Mode Effect, you know many things about this technique now. Without any doubt, this technique has proven itself to be effective in many manufacturing practices and will help your industry as well. Failure Mode and Effects Analysis (FMEA) stands as a powerful tool for preemptively identifying and mitigating potential failures in manufacturing processes or product designs. By systematically evaluating failure modes, their severity, occurrence probability, and detectability, FMEA empowers organizations to proactively address vulnerabilities and enhance product reliability. From identifying failure modes to gauging their severity and probability, FMEA guides teams through a structured approach to risk management. Ultimately, embracing FMEA fosters a culture of proactive problem-solving and continuous improvement, ensuring products meet the highest standards of quality and reliability. Simpliaxis also offers Six Sigma courses, empowering professionals with the methodologies and tools to drive process improvement, enhance efficiency, and achieve excellence in quality management.