FMEA - are you using it effectively?
Alok Ranjan
Co-founder at WalkingTree, Qritrim and EngazeWell| Generative AI, AI/ML and Product Engineering
FMEA has been in existence for more than 40 years and I don't need to introduce Failure Model and Effect Analysis (FMEA). However, for the manufacturing operators, the question I have is
As you would imagine, the objective of an FMEA has to be to identify all the possible ways in which a product, machine, process, pipeline, factory, etc. can fail. At to this the complexity that a failure can occur due to reasons beyond product design. For example - users may use the product in ways that are not suitable/prescribed, or they may expose the product to a condition that hasn't been factored in. So, the job of the FMEA team becomes critical to cover all the scenarios and include them in the FMEA.
The core purpose of FMEA is to prevent failures before they happen. It is a way to identify the failures, effects, and risks within a process or product, and then eliminate or reduce them.?
When you use FMEA effectively, naturally it will help in reducing the potential liability/cost if the product or process didn't perform as expected and enhancing the safety & experience of the customers/users. Hence, FMEA can have a serious impact on the bottom line of the company!
FMEA and Customer Experience
As enterprises realize that they need to move closer and closer to the customers predicting and preventing failure upfront will continue to take the center stage. This will enable them to explore newer business models like considering personalization of their products (may be at a premium cost) for specific needs/desire of the customer.
As we say, the ideal time for planting the tree was 20 years ago and the next best time is now, same applies in the case of FMEA as well. You want to eliminate possibilities of errors/failure as early as possible and build mechanisms to learn about possible failure well in advance.
A through FMEA must be built and used during the design and manufacturing process development phase of the product. However, applying the FMEA on the existing product will be definitely key to higher accuracy of the predictive maintenance models!
We all know that after-the-effect corrective actions create emergencies and unpredictability. While on one end it causes immediate & unplanned productivity loss, on the other hand, it causes loss of brand value and customer dissatisfaction.
When it comes to personalization, you need to be able to understand how the customer's product is functioning, understand the potential risks and fix/repair/replace them proactively. This is where the combination of FMEA and Digital Twin will create an ultimate combination.
Quality Systems and FMEA
FMEA must be part of a comprehensive Quality System to ensure that the company is able to make effective use of data and information. In the software language, the FMEA should be architected in a way that allows Quality Engineers to verify broader use cases, boundary conditions and possibilities with lesser preparation and maximum reuse.
The beauty is that when you integrate the FMEA process with Quality Engineering, it indeed provides you with the process and data to use the same FMEA during production and support. It allows you a great way to document the procedures for validations. That is how you eliminate the guessing game around FMEA.
FMEA and Prioritization of Risks
FMEA looks a lot simpler, but it requires a solid collaboration among the product and process experts. Here are the steps that you typically follow and you can imagine the kind of effort and thought process that you would need to come up with complete list of failure modes and rating for the purpose of prioritization.
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As you would have seen in the above diagram, FMEA typically allows you to capture three parameters in the range of 1 to 10
It allows you to calculate a simple number called RPN, which is a multiplication of SOD and thus it ranges between 1 and 1000. Such a high granularity provides you with clear guidance on which risks you need to address first.
An effective FMEA allows you to identify these risks early and thus you are able to plan and fix lower risks items as well. Everytime you fix, you should be able to rate these failure modes again and recalculate RPN for the reprioritization. Thus FMEA become a running document. That in turn reduces potential failures proactively.
Measuring the Success of FMEA
While there are many ways to create and manage FMEA, and I will speak about our value add as well in a different article, the deal is how you measure if it is helping you or not.
An effective FMEA must help you measure and improve the following:
While you can focus on many things, I believe if you can get good control on improving these things, you will be able to make a serious impact in the topline as well as the bottom line.
Summary
Whenever you need to bring in the collective wisdom and identify the list of potential failure modes and associated risks, FMEA provides you a great process and template to do so. This of course helps you reduce risks across the different stages, including process, design, manufacturing and support. Add to that, while the FMEA originated in manufacturing domain, it can be used in other areas as well - e.g. Financial Services, Software Development, etc.
The main question is - do you use FMEA? Do you maintain it actively? Is it helping you? Let me know your thoughts.
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