The Process FMEA: Template, Use Cases, and Example

Process FMEAs are so useful… and so poorly conducted in China.

There is an art to it, just like there is an art to conducting a solid root cause analysis. It is quite a difficult and unnatural exercise for most Chinese engineers, technicians, and managers.

What is a process FMEA?

It is a formal approach to proactively reducing risks in a process.

A failure modes & effects analysis (FMEA) aims at:

Identifying potential risks
Documenting and keeping track of those risks
Sorting those risks highest to lowest, and focusing more attention on the highest sources of risks
Driving corrective actions that will contribute to an overall risk reduction
Keeping track of the status and the impact of these corrective actions

When to use a process FMEA, and in conjunction with what other tools?

Applying a FMEA to a production process is quite helpful. When there are serious quality issues coming from multiple sources, our consultants tend to follow this sequence:

Mapping the process (in the form of a flow chart)
Working on a FMEA analysis of the process with the factory staff (by simply following the steps mapped previously and wondering, ‘what can go wrong or has gone wrong’?)
Filling out a process control plan to document and standardize the controls — both those already in place, and new ones implemented as responses to the highest sources of risks shown in the FMEA.

(Steps 2 and 3 are quite inter-related and are usually done in parallel.)

Doing a process FMEA is also a great component for a new product introduction (NPI) process. Many companies skip it but it really adds value when an entirely new product is developed. It is a compulsory part of the PPAP (what I would call ‘NPI 2.0’, for makers of OEM auto parts).

Where to get a good template?

A good template you can download is on the Gemba Academy website. There are many others but this is the one we have used as a basis for our company’s template. It is relatively simple and it works.

How to fill out a process FMEA?

The columns most to the left show the potential issues (‘failure modes’) identified and their impact.

Then, each potential issue is rated on the 3 dimensions of risk:

How severe is it, in case if happens? (‘Extremely severe’ is a 10)
How likely is it to occur? (‘Certain’ is a 10)
If it happens, how likely is it to impact the customer, rather than being caught internally? (‘Certain to get to the customer’ is a 10)

(Click on the image to enlarge.)

At this stage, the potential issues can be sorted — highest risk on top.

After that, how to tackle the sources of highest risk? By analyzing root cause(s), thinking of corrective action(s), implementing those actions, following up to ensure those actions are effective, and re-evaluating the risk level.

The best organizations do this exercise regularly. They take actions and update the process FMEA scores. And again. And again.

Common issues with FMEAs

Many failure modes that result in high risks are generally omitted. People tend to overlook some of these aspects: safety, form fit, function, material concerns.

Another issue is, past issues are not taken into account. Actually, past issues on the same or on a relatively similar process are a great starting point for an FMEA!

Here is a longer list of common issues (coming from New Tricks for an Old Tool, published in Quality Progress in May 2017):

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What do you think? What have your experiences been with process FMEAs?

The New Product Introduction Process Guide for Hardware Startups

In this guide, we explore everything that inventors, SMEs, and hardware startups need to know about making a new product in China and bringing it to market.

We include: