History of the FMEA
The FMEA analysis is an common used Lean Six Sigma tool. In the past, the FMEA method was initially used by NASA in aerospace and for high-risk technologies. Since the 1980s, the tool has also been used in the automotive industry for Quality improvement. Nowadays the FMEA is a widely used tool for risk assessment & evaluation mainly in the manufacturing industry.
What is FMEA?
The Failure Mode and Effects Analysis (FMEA) is a structured approach for analyzing potential reliability problems at the start of the development cycle. The tool examines what can be done in the product process to ensure that appropriate measures can be taken to eliminate errors and prevent or reduce their impact. The 10 steps of the FMEA process are explained in a simple way below:
STEP 1: Review the Process
It is important to review the processes that are followed within the company. These processes can be stored in documents or maybe you make use of a dedicated solution for this such as Qooling. Then make a list of each process component in an FMEA table. Advanced QMS solutions allow you to connect the procedure directly to the FMEA table.
STEP 2: Brainstorm potential failures modes
Here you investigate what can go wrong. Therefore, study existing documentation and data which you summed up in the previous step. Identify all the ways in which the process can fail for each component. For example with Qooling you can easily assign the process to every potential failure mode.
STEP 3: List potential effects of each failures
Consider the possible failures and the effect these errors would have on the final product or the next steps in the process. It is important to think thoroughly about the potential effects because this allows you to develop some great solutions to prevent it from happening.
STEP 4: Assign a Severity Ranking for each failure mode
Give a ranking score for each effect. For example, a frequently used ranking is that 1 is not serious at all and 10 is extremely serious.
STEP 5: Assign Occurrence Ranking for each failure mode
Estimate the probability of occurrence of the cause. Also use a scale from 1 to 10 to keep a clear picture of the severity of the causes. Where 10 signifies high frequency and 1 signifies low frequency.
STEP 6: Assign deception ranking for each failures mode or effect
What are the chances the failure will be detected prior to it occuring. Here a score of 1 would mean we have excellent control and 10 would mean we have no control or extremely weak control.
STEP 7: Calculate the RPN (Risk Priority Number) for each effect
To decide where to focus first, multiply the Severity, Occurrence and Detection scores together to find the RPN value.
STEP 8: Develop the action plan
During this step, you must prioritize which failures are processed first on the basis of the RPN scores.
STEP 9: Take action to eliminate or reduce high risk failures modes
Assign new tasks to the responsible person within your organisation. This can be collecting data, changing processes or products, adding or removing functions. A Task Management solutions makes is possible to manage those tasks in clear overviews. The responsible employee and management will receive email notifications whenever important changes are made. This makes it much easier to keep track of the progress.
STEP 10: Calculate the RPN again as the failures modes are reduced or eliminated
It is important to document the changes made to the process. Once the actions are complete, analyze the results. Determine whether the changes have helped and re-score the occurrence and detection.
Making FMEA Easy
A Quality Management Software can help you understand your business processes so that you can identify problems at an early stage. By means of automated push notifications, the solution keeps you alert of changes in your product / development process. This allows you to quickly intervene and reduce the impact of the error. Qooling has a built-in template for FMEA risk evaluation. Contact us if you want to know more on how to use this.