Failure Mode and Effects Analysis (FMEA) is a disciplined approach for determining potential failure modes and the effects they may have on design, process, and system. It is an excellent analysis tool, however, like all systems, mistakes can be made easily enough.
Here we will look at some of the most common mistakes made with FMEA, followed by ways in which to avoid them happening.
For many organizations, they will document what has been done during the process and then file away the FMEA upon completion of that product/process. Never re-evaluating the document and leaving it to collect dust. The aim of a FMEA is to create an actionable plan to reduce the risks of failures within a design/process, and creating an output to CAPA (Corrective Actions, Preventive Actions). If an organization fails to follow the proper procedure for FMEA, they will fail to see the added value and benefit of doing so.
To be successful, a FMEA document is usually compiled upon the agreement of creating a new product or process, or upon the re-design of a product/process. The document needs to be compiled before the production drawings are finalized and regularly updated to fit new situations. Following the proper compilation, the procedure to assure that all the necessary items of information and steps are recorded, analyzed, and documented for future use.
Failing To Use Your Resources
It can seem easy enough to get a group of people together and ask them to look over a design/process to see what risks they can come up with. The danger with this is if the ‘wrong’ people are involved in the FMEA team you risk not identifying the correct types of risks, or people who are not knowledgeable in the required fields.
To avoid this, it is best to put together a small team of key individuals from selected areas who are knowledgeable and open-minded to all possibilities. The skills each team member holds need to be complementary to the others. Having the correct team working together means time is well spent, effective action is driven, and everyone is on board with the proper procedure.
Lack of Understanding of the Basics of FMEA
Anyone can look at a product, design or process and determine basic risks, ones that are usually blatantly obvious effects that could be identified by the customer. The skill is to identify the symptoms of these risks before they arise. The key to a successful FMEA is identifying the high risks that are not so blatantly obvious.
Having the correct knowledge to understand the basics, and beyond, of FMEA reduces high-risk failure modes from being overlooked, and addressing them with a more adequately effective action. A key piece of knowledge needed when compiling a FMEA is how to calculate the Risk Priority Number, as this helps the team determine which risks must be focused on first. Without this knowledge, a FMEA is just a collection of risks without a plan of action. A knowledgeable team member will be able to identify symptoms of a failure mode, as well as its resulting effects that would be noticeable by a customer.
If your organization is looking to incorporate a FMEA into its risk assessment, particularly with the new ISO 45001 coming into play as early as February 2018, then do get in touch and see how my courses can help you today.