What is Failure Mode Effect Analysis (FMEA) and why is it important?
Failure Mode Effect Analysis is a methodology that enables organisations to identify and prioritise potential failures and design and implement effective corrective actions to prevent their occurrence during the design stage of a product or process.
Failure modes are the ways in which a specific product or process can potentially fail, and the effects are all the negative outcomes these may create for the customer.
FMEA is one of the 5 essential automotive quality core tools which helps support the expectations of IATF 16949:2016.
FMEA is one of the most effective and low-risk methodologies for predicting and prioritising potential problems and identifying and implementing the most cost-effective solutions for preventing their occurrence.
FMEA will help save your organisation time and money by discovering and correcting failure at its earliest possible point in the design of a product or process.
When should you perform a Failure Mode Effect Analysis?
FMEA’s should always be performed:
- During the design of a new product or process.
- When changing the design of an existing product or process.
- If you want to achieve quality improvement goals for a product or process.
Remember you should also aim to periodically carry out FMEA’s during the saleable lifecycle of your product. It is crucial to evidence and assess all changes which can affect quality or reliability that may occur.
How does a FMEA work?
Once you have identified a potential failure mode, the data can then be analysed and prioritised by quantifying 3 different factors. These are:
- Severity (S) Ranking: The severity of the effect of the failure on your customers.
- Occurrence (O) Ranking: The frequency with which failure or potential cause of failure could occur.
- Detection (D) Ranking: The chance that the failure will be detected before affecting your customers.
Each of these 3 factors is ranked on a 1-10 scale, with 1 being the best and 10 the worst. The sum of these 3 factors (S x O x D) is then calculated to give you the Risk Priority Number (RPN).
The RPN is then used to place priority for corrective action on these potential failure modes.
What is a FMEA Process Template
A FMEA Process Template outlines all the necessary steps your organisation must perform to ensure you successfully identify potential areas of failure for a product or process, correctly prioritises them, and implements the most effective corrective action.
The FMEA process will never be identical for all businesses as it will vary according to both the requirements and objectives of your individual organisation.
Our free example, which you can download below gives a rough idea of how a FMEA process should run but you should be sure to tailor it more specifically to the needs of your organisation.
We also recommend using our FMEA Process Template in conjunction with our FMEA Form Template which can be downloaded here.
How to create your own FMEA Process Template
To create your own streamlined FMEA process template, you will want to begin by considering what the scope of the process is and the objectives you want to achieve with it.
For a FMEA process, your main object is to successfully identify and prioritise potential modes of failure and design and implement effective corrective action to prevent its occurrence.
Once you have determined your scope and objectives, you now need to determine the start and endpoints of your FMEA process template.
In our example, we chose to start our FMEA process with the identification of the product or process to be analysed and end it with either the closure of the FMEA or the re-calculation of the RPN rankings.
After you have established your start and endpoints, you can now fill in all the connecting steps that are required to help move the FMEA process through from beginning to end.
Consider all the steps that must happen within your FMEA process to ensure it is carried out successfully, such as determining the severity, occurrence, and detection rankings, calculating the RPN, and determining effective corrective action.
Using Jomo247 to create your own FMEA Process Template
Now that you have finalised all your planning, you can now create your own FMEA Process Template.
You may prefer to use traditional methods that enable you to create a basic stationary image of your template.
However, we recommend using a software like Jomo247 that not only allows you to fully design and customise your processes but also automate them with ease.
If you are interested in reading more about automation, click here.
Once your FMEA Process Template design is complete, it is now time to implement it into your daily operations.
Remember it is critical whenever you implement a new process that its performance is constantly monitored, and adjustments applied as needed.
Undertaking and recording the continual improvement of your processes is key to ensuring that your organisation conforms to IATF 16949:2016.