Today, when a customer wants to buy a product or hire a service, in addition to the sales price, quality and delivery time, they also try to understand how dependable this product/service is, as reliability is an important factor to be considered before making a decision regarding their supplier.
But what if your process doesn’t work the way it was originally defined? And when the product starts to fail? Defects, production issues, downtime and product recalls are costly and affect a company’s reputation as well as customer satisfaction, and in some cases even compromise consumer safety.
FMEA is one of the methods used to handle such issues and identify their causes and effects, focused on assessing risks. The acronym means Failure Mode and Effect Analysis.
As its name implies, FMEA is a method used to understand and analyze all the failure possibilities of a process, product, or service and, if the failure occurs, what are its effects and consequences. In addition, this analysis is performed to assess the level of risk associated with these failures, in order to correctly rank their importance in order to eliminate or reduce them.
For this reason, FMEA is widely used by different types of companies worldwide and can be key for businesses to prevent consequences from errors.
But if you still don’t know the FMEA method, don’t worry. We have gathered here all the necessary information: what it is, the correct way to apply it and its benefits, to answer all your questions once and for all.
Benefits and advantages of using FMEA
As mentioned, FMEA is a method developed for failure prevention and risk analysis, to analyze failures and determine their respective risk level in order to resolve them as quickly as possible. Failure to adopt this approach in your business may not only lead to dissatisfied customers, but it could also put their health and safety at risk.
By identifying all failure modes, those responsible for the process can enable the implementation of solutions that, at the very least, minimize the impact of these problems. Another great advantage offered by the tool is savings for the company. In a manufacturer, for example, reduced failures in the manufacturing process are directly linked to the reduction of rework and labor costs, as well as use of raw materials.
Thus, the implementation of FMEA can provide several benefits to your company, including:
- Improved reliability and quality of products, processes, and services provided;
- Reduction of costs and materials;
- Identification and quantification of failure probability;
- Registration and monitoring of actions taken to mitigate risks;
- Helps to identify the problem cause;
- Reduces the likelihood of failures, reworks, returns, and customer complaints.
It is important to apply FMEA:
- When analyzing failures of existing processes, products, or services;
- When designing or redesigning processes, products, or services;
- Before implementing improvements and changes;
- Whenever you are analyzing weaknesses in processes or products and need to prioritize which are the most critical;
- Regularly throughout the life cycle of a process, product, or service.
How to apply FMEA?
To properly implement FMEA in your organization, you must follow a simple step-by-step, which consists of, at least, the steps outlined below:
Step 1 – Scope definition
In this step, you must define the object of study of your analysis.
What will be the process, product, or service to be analyzed?
Step 2 – Establish a multidisciplinary team
Assemble a multidisciplinary team of professionals with different knowledge and experience about the object of study to be analyzed. This selection is extremely important because you need people to expose what can go wrong and potential solutions based on their experience with the object of study under analysis.
Step 3 – Gathering information
In this phase, you and the team will collect any and all information about the specification of the product, service, or process to be analyzed.
Step 4 – Failure modes
The team responsible for implementing FMEA will start the analysis by identifying all failures that may occur.
Step 5 – Effects
For each failure mode, identify all consequences for the object of study, these are the potential failure effects.
In this phase, you and the team should ask the question, “How do customers feel about this failure? What happens when it occurs?”
Step 6 – Severity
After identifying the failure effects, it is time to determine the severity of each effect. Severity is usually rated on a scale from 1 to 10, where 1 is negligible and 10 is very severe.
Step 7 – Causes
Then, for each failure mode, determine all potential failure causes. You can use cause analysis tools such as the Ishikawa Diagram, 5 Whys and Brainstorming, as well as the team’s knowledge and experience.
Step 8 – Occurrence
For each cause, determine its occurrence likelihood. This ranking estimates the probability of failure occurring and can be rated on a scale from 1 to 10, where 1 is highly unlikely that the failure will occur and 10 is unavoidable that the failure will occur.
Step 9 – Controls
Next, for each cause, determine its current control. These controls may be tests, procedures, or mechanisms that you have in place to prevent failures from occurring or being detected before they affect customers. These controls can prevent a cause from occurring, reduce the likelihood of it occurring, or detect a failure if it does occur, but before customers are affected.
Step 10 – Detection
For each control, determine the detection level. This level estimate ranks the ability to detect the failure cause or mode after it has occurred, but before the customer is affected. Detections are typically scored on a scale from 1 to 10, where 1 means the control works and the problem can be detected, and 10 means the control definitely does not detect the problem, or worse, no control exists.
Step 11 – RPN Calculation
After defining your severity, occurrence, and detection rankings, calculate the Risk Priority Number or RPN, by multiplying the three scores: Severity × Occurrence × Detection. The RPN results provide guidance on the order in which potential failures should be addressed.
Step 12 – Action plan
After defining the RPN results, the items with the highest score will be the ones that must be addressed first. Thus, in this phase, proposals for improvements and important items for their implementation will be defined, such as: responsibility, deadlines, steps, etc.
These actions could be design or process changes to reduce the severity or incidence of failures, or they could also be additional controls to improve detection.
Step 13 – Assessment of implemented measures
As the actions are completed, the FMEA team should meet again to discuss the current progress of the action plan, verify if there were actual improvements, and observe if the actions caused changes in the RPN results, through improvements in the severity, occurrence, or detection scores.
Conclusion:
Most companies still implement FMEA in Excel; however, Excel is not the best tool to apply FMEA. Users have to do a lot of additional work to follow FMEA rules, create documentation, create links between process flow and control plan, but most importantly, keep history records of all documentation. Therefore, I invite you to learn more about SoftExpert FMEA. The solution helps organizations increase productivity and reduce costs by meeting the requirements set by international standards and regulations such as IATF 16949 and ISO 9000.
To find out more about the advantages and benefits that SoftExpert FMEA can offer your company, contact our experts. They will focus on understanding your challenges and suggest the best way to implement the FMEA solution to meet your needs.
