How to Assess your Manufacturing Risk – with FMEA

“What could go wrong?”

That is the central question every manufacturing team must ask before a finished design goes into production?

The fact is every manufacturing project comes with a certain amount of risk.

Sometimes the risk is minor, but sometimes it’s a serious risk that could significantly impact the product’s users, customers or the community at large.

At other times it’s a risk to the product owners and/or investors usually in the form of a financial or reputational loss.

In all cases, manufacturers want to avoid risk – or at least mitigate it – before they go into production.

One way to do that is to conduct an FMEA.

You may know it more specifically as an Application FMEA, or a Design FMEA, or Process FMEA.

FMEA stands for Failure Mode and Effects Analysis.

It is where all parties involved in the product development process can get together and predict what risks – minor and major – may be associated with that product.

When you conduct an FMEA, you start with the assumption that failures will happen.  But then you have to ask:

• How serious will those failures be?
• How much of an impact will they have on the customers, users or community at large?
• How much of an impact will it have on the company itself?
• How likely is it they will occur?
• What can you do to mitigate the problem?

Different types of FMEAs

FMEAs are used to assess risk with various aspects of the product development and manufacturing process.

1. Application FMEAs examine the risk related to how the product will be used – and are typically conducted by the company’s marketing team.

2. Design FMEAs look at the product design itself and tries to identify potential failures in every element of that design.
3. Process FMEAs analyze the manufacturing process and the risks related to every step in that process – from the supply chain to assembly and testing to packaging and product support.

Here at Product Resources, we routinely conduct both Design and Process FMEAs.

‘You can pay me now or pay me later’

Back in the early 1970s, FRAM oil filters ran a TV commercial with the slogan, “You can pay me or pay me later.”  It was a warning to automobile owners to replace their oil filters (now) or run the risk of an expensive engine replacement (later).

That same message could be applied to FMEA.

You can spend a half day in a conference room with your engineering team to identify and mitigate potential risks, or you can do nothing and wait for the public – your customers – to find the problems themselves.

If you wait for your customers to discover the problems, your costs will likely be much higher.

Outside of medical devices and products used in explosive atmospheres, FMEA isn’t required, but it is always recommended.

Finding that level of acceptable risk

Throughout the FMEA process, your team will want to prioritize those risks that are most severe, that could result in death or serious injury. Those risks need to be addressed first and foremost.

But there will be other risks that are much less severe, that might be considered an acceptable level of risk. These are risks that could result in disruption more than injury, that could be remedied at minimal cost.

This is where the product development team will need to make some judgements as to whether the mitigation costs are worth the effort.

The need for reasonableness

With enough imagination, you could probably come up countless scenarios where your manufacturing process faces some level of risk.

Some of those scenarios will be farfetched and unlikely to actually happen.

For this reason, you need to establish some level of reasonableness, and this can be determined early on by the team leader.

The Risk Priority Number (RPN)

But some of scenarios will be close calls – and, for that, we have a Risk Priority Number, or RPN.

The RPN is used to calculate the risk along three factors:

• Severity – how severe will the outcome be with the failure?
• Occurrence – how often or frequently will this failure occur?
• Detectability – how likely are we to detect the failure?

Each of these three factors are ranked on a scale of 1-10, then multiplied together to create an RPM.

No project is without risk.  But there is such a thing as an acceptable level of risk, and the RPM will help you establish that level for each project.

FMEA and the supply chain

Managing complex products, especially medical devices, require an FMEA early in the process to catch many of the early mistakes that are bound to occur.

It often starts with the procurement process when parts are specified and when suppliers are identified and qualified.  It’s also part of the delivery process when parts are received, inspected and documented.

Very often as products are designed and prototypes developed, the design team will rely on whatever parts are easily accessible.

This may include ordering individual parts online from companies like Amazon.

While these parts may work just fine for a prototype, selecting these parts for manufacturing is a very different process.

FMEA and regulatory expectations

Medical devices and products that are used in explosive atmospheres are required to have an FMEA or some similar due diligence process.

When you develop a Process FMEA, it should be viewed as a starting point for your manufacturing process.  It’s not something you do once and consider it done.

It’s a working document.

Too often, as you go through the Manufacturing process, you will discover new risks that were not identified earlier. And so, you need to update your FMEA throughout the process.

The Critical Components List

Many times, a new product has received regulatory approval for design, but that approval is contingent in your use of Critical Components List that was specified in the design.

This Critical Components List then becomes a requirement for manufacturing where those particular parts – and only those parts – must be used.

This needs to be documented as part of the FMEA.

FMEA – How it all works

The FMEA process isn’t a long process, but it does require participation by multiple stakeholders in the project – who must all be available at the same time.

Participants might include representatives from engineering, manufacturing, testing, quality and operations – all with a different angle on the project.

The commitment of time will vary depending on the type, size and complexity of the product, as well as the seriousness of the product.  Medical devices, for example, can take two full days or more to complete while simpler, less regulated products might take only a couple of hours.

Time can be managed effectively by a coordinator who needs to establish some standards and guidelines for the FMEA process.