You have been asked to do an audit of your process or product. How do you effectively audit an FMEA in your manufacturing operation? When you look at the FMEA you are auditing risk, so let’s explore risk.

According to ISO 9001:2015, paraphrasing, “Risk is the negative effect of uncertainty.” So, the conversation that you are having around the FMEA is that there is uncertainty, which is unfavorable, which is called risk, and the FMEA is expression of that risk.

This is different than the Control Plan, as an example: A Control Plan is very finite. You are supposed to check five pieces, you are over checking three, it is very easy to audit because there are a lot of numbers.

How to Audit an FMEA
To effectively audit a FMEA you need three things:

First, have the document that explains the risk profile that the industry or the organization has communicated to the customers (FMEA).

The second thing you need to have is the Customer Specific Requirements (CSRs) and organization requirements, that the organization signed up to. When they took the job, what are the costs and what do they do with the FMEA.

The third thing you are going to need is the performance of that FMEA.

Not talking design or process individually, because it is all the same.

You take the FMEA which is the expression of that risk that your product or process causes. Compare it against the CSRs and the organizations own requirements that it came up with. Lastly, you look at the performance of that FMEA relative to these targets in the CSR. 

That’s it. Fundamentally, that is how to audit an FMEA.

There is no such thing as a world with zero risk. If you are trying to get to zero that is a falsehood, and it is an imaginary object. The FMEA is the expression of that risk that the product or process causes in the customers product.

Tie it back to Performance
In the customer reaching out and taken that FMEA in and signing that PPAP, they have accepted that level of risk for that process or product, and that is why you must tie back to performance.

A lot of you may be looking for special characteristics to audit, looking for the answers of how to do this from a ritual standpoint:

The FMEA is a performance-based document. Which means you should not let the ritual of how it looks in the format be more important than the results that it derives for the customers. Because remember, you are auditing customer satisfaction. 

To learn more about FMEA visit our Blog or browse training programs in FMEA, AIAG Core Tools, and more.