Key Points

• FMEA has several variants that allow for minimizing risk throughout product development.
• Design FMEA is a handy means of implementing lasting changes into your project before it reaches open production.
• Process FMEA is a way to enact solutions to potential risks in your final product.

How can you use FMEA in product development? I’ve talked at length about using FMEA as a means of rectifying problems in production. However, you can apply the methodology to the design process of any product or service you’ve got in the works. It isn’t similar to DMAIC, as DMAIC is generally used to refine processes after deployment.

Today, we’re looking at how FMEA applies to the entire design process. This flexible methodology has different variants that can be used throughout product development to account for failures while also delivering a quality product as a result. If you’re not familiar with how to implement it, you’re in the right place. We’ll cover what you need to do, and how to effectively minimize risk and potential failures throughout the entire process.

What Is FMEA?

FMEA is Failure Mode and Effects Analysis, a systematic approach to rooting out potential pain points and determining their overall causes on a production. Proper implementation of FMEA means you’re not concerned about defects or faults arising in production, because you’ve hopefully remediated those problems before there is reason for concern.

FMEA is a flexible approach, usable throughout all industries, especially when considering the different variants. Typically, you’ll work down the line, breaking down components of a process or product, with some flexibility. FMEA can be down in the details or high-level as you want to go, depending on time and resources.

FMEA determines the pain points and assigns them rankings, based on the severity and rate of detection among other deciding factors. This ranking, or RPN, is how you determine which failure points you’ll want to prioritize first. This leads to a flexible approach that can be as involved or as nimble as necessary.

Why It Works

When developing any sort of product, service, or project, it can be a little easy to get lost in all the details swirling about. However, where FMEA excels is in taking those rather disparate elements we associate with failure modes and turning them into quantifiable and actionable data. Knowing that you’ve got something in the production line that goes down is fine and dandy.

That said, think about the power you leverage from giving that machine downtime a ranking. You determine its severity to workflow, the rate at which it happens, and how fast you can detect it. When assigning a ranking, you can readily dictate how much focus needs to be on that machine.

This is where FMEA shines, in helping your organization develop lasting solutions to things. By giving the qualitative quantity, you can focus your efforts on points where a keen eye is sorely needed. It is something that we see across organizations all across the world who are leveraging FMEA to spend less time fixing things and more time shipping quality deliverables to their customers.

Implementing FMEA in Product Development

Now, we’ve defined the approach and highlighted things. How do you implement FMEA throughout the development process? Well, that might seem rather daunting at first glance but don’t fret. The different types of FMEA allow for a flexible and systematic approach to locating pain points throughout the whole of the product development cycle.

We’re going to highlight the potential stages of a product’s lifecycle, the variants of FMEA to use, and how they’ll apply throughout the entire process. The steps you’ll take to implement FMEA aren’t going to change, regardless of the variant you’re using. However, what it allows you to do is account for potential failures all along the way. So, let’s dive right in.

Concept

You don’t bake a cake without a recipe, and the same applies to any product. When drumming up a new product or service, there’s plenty of brainstorming before honing in on the components and elements needed to make this a reality. However, depending on your organization’s approach, you might have different ways to approach quality.

Many organizations will spend time hammering out the particulars like suppliers, materials, shareholders, and so forth, at least if an organization is adhering to the Lean Six Sigma methodology. This is a fine process to still uphold, but you can readily implement FMEA in product development, even during the conceptual planning of your new product or service.

Functional FMEA

Functional FMEA can be seen as the primordial, elemental variant. Its use is typically in determining the systems and details that go into the development of new products. Where it shines is providing a means of mitigating risk before the final design of your product is even fully realized. As such, if you’re looking for at least one variant of FMEA in product development, this might be the ticket for guaranteeing continued success.

You’re already likely using other tools at this stage of your product’s development, so taking the time to isolate the constituent elements and their potential failure points might be just what you need.

Use of Functional FMEA in Planning and Development

Where Functional FMEA in product development excels in taking a look at the various components of your product before it even hits the design and implementation stage. You can isolate failure points in the likes of raw materials, OEM components, and even manpower if absolutely necessary. This puts it ahead of DFSS in some regard, as you’re not accounting for every eventuality.

By looking at the functional requirements, components, and elements that will comprise your product, you’re essentially guaranteeing a pain-free transition to the actual development and implementation of said deliverable.

Process Planning

Another area where FMEA in product development is worth considering is during the actual planning stages of your processes. You’ve hammered out the details, identified your stakeholders, and are ready to start drafting out the design process. There is still plenty that can go wrong at this stage, as nothing is finalized just yet.

We aren’t quite at the spot where the rubber meets the road, but we’re getting much closer. Thankfully, there’s an FMEA variant tailor-made for making the most of your process planning.

Design FMEA

Design FMEA is where you’re looking for potential fail states in your product before development has begun. For example, you might use it to look for failure points in something like a car. You know multiple components can face any sort of catastrophic failure during this process.

Design FMEA breaks down potential components and allows you to address them. Like the other variants, it establishes a hierarchy or ranking of potential failure points. Once those are established, you’re then ready to start implementing lasting solutions into the product.

Design FMEA in Project Development and Construction

Where Design FMEA excels is in looking at the relative risk of any factor of a product’s design. While going through the design and later implementation of your product, plenty can go wrong. As with the other variants of FMEA in product development, this is where you’re taking a look at all eventualities. Implementing remediation into the design of the product itself means you’re focusing heavily on quality.

At the end of the day, businesses live and die by the quality of their products. You don’t last on the open market with a subpar product, so utilizing FMEA to suss out pain points is a powerful tool. As with the other variants, you’ll want to keep extensive documentation of the changes made. We’ll touch some more on that last point with our final variant, however.

Final Production

At this point, this is where the final design goes to your production line. The rubber has met the road, and you’ve begun to ship products out to customers, vendors, and so forth. Now, this is always a tricky place to consider, especially if problems arise. I’m a firm believer in Murphy’s Law, so let’s just assume they will.

My time in tech has taught me some valuable lessons when it comes to getting the final service to your customers. Things will go wrong at the absolute worst opportunity. You want to make sure there is minimal potential for things to go awry, so we’ll turn to the final FMEA variant you’ll want to consider.

Process FMEA

Process FMEA is arguably the one we’ve spent the most time focusing on when discussing the topic here at iSixSigma. This is one of the most vital FMEA variants you can utilize, as this is where you can enact lasting changes in your production workflow.

One thing I will touch on is the necessity for documentation. You’ll want to catalog everything you’re doing throughout the FMEA process, allowing for historical reference when embarking on this again. It also serves the purpose of allowing you to follow good practices when developing a new product.

Process FMEA is focused on the core components of a process, allowing for the development of solid solutions. As with all the other variants covered, you’ll want to do your due diligence when constructing these plans.

Putting It All Together

The final FMEA variant used is vital for determining the potential risks of your final product. As I’ve said, things will and can go wrong throughout any stage of a product’s lifecycle. Learning how to utilize FMEA to supercharge your risk assessment is a valuable way of keeping a few steps ahead without compromising your customer’s trust in your organization.

Other Useful Tools and Concepts

We’ve talked about FMEA at length, but that isn’t the only tool at your disposal when it comes to mastering the business world. Learning how to leverage artificial intelligence for your business while taking a look at how major industry leaders are utilizing it. AI is a hot-button topic and something that is going to continue to see innovation as the technology grows more sophisticated.

Additionally, you might want to take a closer look at how to avoid the most common mistakes when constructing Ishikawa diagrams. Learning how to utilize this basic QC tool is one of the most effective ways to determine the root cause of a potential problem. However, there are some cases where its use goes very wrong.

Conclusion

Hopefully, you come away from today’s guide with a keener understanding of how to apply FMEA in product development. It is a flexible approach for remediating issues before they even arise, so learning how to effectively leverage it is going to be one of your most powerful tools. FMEA is a great means of leveraging your team’s resources to guarantee quality throughout the entire project development cycle.

The image featured at the top of this post is ©Depiction Images/Shutterstock.com.