What is Failure Mode Effect Analysis or FMEA Form Template and why is it important?
Failure Mode Effect Analysis is an efficient and low-risk methodology for identifying and prioritising potential failures so that your organisation can design and implement effective corrective action to prevent their occurrence during the design stages of a product or process.
Failure Mode Effect Analysis is one of the 5 quality core tools which are essential in supporting organisations in the automotive industry meet the expectations of IATF 16949:2016.
Failure modes are all the potential ways a product or process could malfunction, and the effects are the consequences these may create for customers.
By identifying and correcting failure at the earliest possible point in the design of a product or process, your FMEA form template will help save your organisation both time and money.
When should FMEA’s be performed?
It is critical that you perform a FMEA during the design of a new product or process or if you are changing the design of an already existing product or process.
However, you should also carry out periodic FMEA’s throughout the saleable lifecycle of the product. Remember it is crucial to thoroughly assess and evidence all change that might affect the quality or reliability of your product.
How does a FMEA work?
Once you have thoroughly determined a potential failure mode, your data can than be analysed and prioritised by quantifying 3 key factors: These are:
- Severity (S): This ranks the severity of the effect of the potential failure on your customers.
- Occurrence (O): This ranks the frequency that failure or potential failure could occur.
- Detection: This ranks the chance that failure will be detected before it can affect your customers.
Each one of these key factors is given a ranking from 1-10, 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 prioritise the application of corrective action upon these potential failure modes.
What is a FMEA Form Template.
A FMEA Form Template comprises all the necessary fields that must be filled in during the FMEA process to ensure that your organisation successfully identifies areas of failure for a product or process, prioritises them correctly, and implements successful corrective action.
A FMEA Form will not always be the same organisation to organisation as it will vary according to your individual requirements and objectives.
Our free example, which can be downloaded below gives a rough idea of the fields a FMEA form should include but do be sure to tailor it specifically to the needs of your individual organisation.
We also recommend using our FMEA Form Template in conjunction with our FMEA Process Template which can be downloaded here.
How to create your own FMEA Form Template
Your Failure Mode Effect Analysis Form Template should be designed to optimise the collection of data that will allow you to successfully identify and prioritise potential modes of failure and subsequently design and implement the most effective corrective action to prevent its occurrence.
This form should be filled in at each relevant step of our supporting FMEA Process Template which you can download here.
It is best to design your FMEA Form Template in table format for ease when filling it out.
The first column of your table should be where you record which product or process is being analysed. This should then be followed by a column where the requirements of these products and/or process can be defined.
Your table should include columns where you can collect detailed information about a potential failure mode, its causes and effects and any existing prevention and detection design controls you have in place.
Your table should also include columns to record the number given to your severity, occurrence and detection rankings and a column to record their sum as the RPN number.
By quantifying these 3 key factors, it will make prioritising your potential failure modes much easier ensuring you are dedicating time, money, and resources for improvement to the most pressing areas.
The second half of the table should be dedicated to recording any corrective actions that have been determined, who is responsible for them, the date they were completed and if they were successful or not.
This allows you to establish traceability and accountability whilst also evidencing your commitment to improvement.
Be sure to include columns for the re-ranking of severity, occurrence, and detection so that you can compare the RPN prior to and after corrective action to ascertain how successful it has been and whether any further corrective action may be required.