FMEA Saves Lives!

"How long has FMEA been around, Graham?" I was recently asked.

"About 60 years" was my reply

"Why aren't we all getting it right then?" Good question I thought.

"People need too get their act together. Its your duty to tell them how!"

So, on that note, allow me to share some thoughts with you.

When I have challenged FMEAs in the past I have been given various reasons for failure:

• It was just a paperwork exercise to satisfy an audit
• Compliance
• We didn't understand

This frustrates me becasue the consequences of a badly executed FMEA could result in injury or even death!

So if you think that you could benefit from a better understanding then read on,, as there are four aspects that need to be fully considered if an FMEA is to be effective.

The four aspects are as follows:

Boundary Diagrams which will focus your efforts

Understand design functions

Understand unintended design functions

Get control and stop things going wrong

1. Boundary Diagrams Focus Efforts

Get your team focused!

Set a boundary diagram for the FMEA.

After the design functions have been established, revisit the boundary to ensure that the FMEA considers the design in the context of its full operating environment.

Check with the team to see if any new knowledge or support from outside your team is required. Why guess when the knowledge exists with others in your organisation?

For the most part, boundary diagrams are produced without looking beyond the 'obvious', only considering the direct connections

The boundary diagram MUST reflect ALL conditions of use and application.

2. Understand Design Functions

Why is it that we don't look beyond the obvious functions?

Why don't we look at functions from a customer perspective?

What is the function of a pen? (see answer at the end!)

This is a basic design principle that all too often is not applied!

Using the Function Tree, develop a full understanding of your design funtions, then carry these prime functions forward into the FMEA

 3. Understand Unintended Functions

Do you open the microwave door to turn it off sometimes?

Do you use the steering wheel as a support to help you get in and out of your car?

Have you ever used a small screwdriver as a bradawl?

Let's face it, this is real world stuff - not all of your customers will use your products in the same or even in the intended way! Some users will intrduce unintended functions - from light to heavy use.

In terms of the design intent should you take these into consideration? Of course you should, it is necessary to consider unintended functions. Sometimes, defining such functions is critical to the products success.

4. Stop it going wrong!

The great thing about FMEA is that it never limits creativity but it does help you to decide the best available option - especially when it concerns customer safety!

In Design FMEA (DFMEA) current controls are all based around the design process and confirmation, verification and validation testing of that design. However there must be a thorough and honest review of how effective these controls will be in detecting failure.

Consider the following:

• Do your tests contain the conditions for both light and heavy customer usage profiles? A light user could cause higher levels of stress upon a given design
• Is the test population significant enough to ensure that the failure mechanisms will be present? If only 5 are tested, is this a significant enough quantity when you are looking to sell 5 million with a life expectancy of 5 years or 250,000 cycles?
• Does the test sample represent a true manufactured situation? Often prototype parts are used that do not feature the process variation experienced during manufacture
• Are design strength issues considered as part of the test? Depending on the manufactured condition the design strength has a distribution of its own
• Is the control in question in use now or intended to be used / developed at some time in the future? Only those controls in use / available at the time of the FMEA should be considered

So what is stopping you from doing it right?

Don't think you need to? Don't want to? Don't know how to? Didn't know it was important? Don't have the time?

Now you have no excuse! Go to our FMEA page to review all of the resources available for download

Alternatively, if you have a question or need help, you can contact me directly:

Graham Cripps

graham.cripps@resultsresults.co.uk

Tel: 01371 859 344

www.resultsresults.co.uk

You can also access an FMEA snapshot by clicking on the icon below:

P.S. What is the function of a pen?

If you said write, I’d say wrong!

Here are just a few functions of a pen: contain ink, provide grip, dispense ink

A pen will only write if it is used as part of a larger system – got it?