Failure Mode And Effects Analysis
A Failure Mode and Effects Analysis (FMEA) is a popular tool used across many industries to proactively identify and address potential risks within a chosen process–in our case, a particular manufacturing process. The analysis provides a deeper understanding of what the risks are and encourages planning for how to address any problems should they occur.
At MedFab, we use these types of analyses to both maintain and improve our manufacturing processes so that we can continue to offer high-quality parts to our customers.
The Steps of a Failure Mode and Effects Analysis
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Assemble a Dedicated Team: This doesn’t just mean getting a small group of people together–it involves building a multidisciplinary team of individuals, each with their own unique expertise and insight into each part of the manufacturing process in question.
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Define the Scope of the FMEA: Once we have a team together, that team then determines what the FMEA is actually going to be about–a concept, system, process, design, etc.? They determine how detailed the analysis will be, what will need to be done in order to fulfill the requirements of the analysis, and who will be identifying each part of the information necessary.
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Gather Information: Once the team has set the scope for the analysis, they then gather any relevant identifying information to fill out the FMEA.
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Define the Function of each ‘Scope’: While this might seem a little repetitive, this step is actually very different from step 2. The analysis team takes each aspect of the FMEA’s scope and looks at its function. For instance, they’ll look at the particular manufacturing process and determine what it does and what is expected from it in terms of its actual operation.
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Identify Failure Potential: ‘Failure Potential’ refers to the ways that a particular part of the ‘scope’ could lose its function. This could be equipment failure, operator failure, or even failures due to conditions beyond control, such as unexpected power outages or weather events.
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Identify the Consequences of each Failure Mode: Once the team has determined all of the ways that a particular process could fail, they then determine the possible consequences of each failure on the individual scope and the production system at large.
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Rate the Severity of Each Consequence: Now, the team rates the severity of each consequence, providing them with a better idea of which failure modes need more attention than others.
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Determine Root Causes of Each Failure Mode: With all of this discussion and careful documentation complete, the team can then move on to figuring out what the real root cause is of each failure mode. This provides them and the company at large with a better understanding of what they can do to move forward and improve.
Contact MedFab Today For More Information
If you have any questions about MedFab’s quality management or control processes, or if you’re ready to request a quote,
don’t hesitate to contact us today.