Incoming products are important to a Process FMEA (failure mode effects analysis).  We check it all the way through the PFMEA. We assume it’s good coming in. We know it’s not.  

Let us explore the idea of a process approach and roll throughput yield when it comes to the PFMEA. The PFMEA a lot of times we will see certain failures, such as the tool breaking due to preventative maintenance not being performed correctly. The operator placing one part incorrectly because they were not trained properly.  

This is an opportunity to talk about inputs, because is preventative maintenance a process? Yes, and if you gave preventative maintenance, its own PFMEA, would it have its own occurrence value to how often it might miss, preventative maintenance? Yes. Would it have the protection value to say if it missed the preventative maintenance interval or didn’t perform it correctly, maybe it would not be able to detect it within its system? Yes, and would there be a severity which would be your impact to your manufacturing line? Absolutely! 

The way we look at manufacturing in PFMEA can be applied to all support processes. 

Think about it this way: 

That training process where the operator placed one part in before the other, if the line is not responsible for its training, did that operator go through the training process? Would there be an occurrence, detection, and severity combination, for passing an untrained operator over the manufacturing floor. 

Absolutely. 

The purpose of these questions is to get you thinking about the PFMEA is here, but it is supported by calibration, training, preventative maintenance, work instruction generation, a whole lot of other processes, and each one of those processes carries within a risk profile. 

So, when you think about it in your organization many times your manufacturing operations are impacted, not by its own manufacturing equipment, but by the support processes. You can help it along its way. 

You want to make it more actionable. If you create an FMEA around a support process, treat that risk profile the same way as you would incoming product. If preventative maintenance says ‘the severity if I miss maintenance is going to be a seven’, because you’re going to have downtime, then the occurrence value we miss in maintenance is going to be a four, because we do it, and the detection value is going to be at eight, because if we miss that interval we may not know. 

You now have to task your own operators with making sure the maintenance is done, because what they have told you is, there is a very real chance it may be getting missed.  

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