FMEA Archives - Page 2 of 2 - Quality During Design

Prevention Controls vs. Detection Controls

Dianna compares different types of controls in product development and design engineering: Prevention Controls vs. Detection Controls. She reviews concepts, uses for controls, risk-based controls, and how to prioritize design efforts for the right controls.

Choosing a Confidence Level for Test using FMEA

We should choose a confidence level for our requirements or their test plans. We can associate that confidence level with the level of risk associated with our product. FMEA is a great tool for us to refer to, to help us choose a relevant confidence level by basing our decision on one or more metrics that the FMEA can provide.

Getting Started with FMEA – It All Begins with a Plan

We’re starting to populate an FMEA table with our team. We get it started, but then we get stuck in disagreements. Or we think we finish it and then we don’t know what to do with it.

We can avoid these headaches with a little planning (or maybe a lot of planning – it depends on the project). We talk about risk management planning, as it relates to FMEA.

How many controls do we need to reduce risk?

When we’ve identified a risk to our design or user process – and that risk can pose a potential harm – how many controls do we need to add? We discuss prevention vs. detection controls, ALARP, as low as possible, and some scenarios where we could (and maybe couldn’t) justify a risk as acceptable without…

Designing Specs for QA

Creating specs for suppliers and producers is generally at the forefront of our thoughts about the activity. But, it’s also important to design for our QA friends, too, for inspection. We talk about what acceptance sampling is all about. We also step through a thought process for identifying and creating design features for inspection using…

Every Failure is a Gift

When designs fail we can take on damaging mindsets while we’re deciding our next steps, and this can lead us to bad decisions. We explore this and give some examples of pitfalls. We also talk about what to do within the design-realm to prepare for and combat those mindsets. Finally, I share my mantra when…

Remaking Risk-Based Decisions: Allowing Ourselves to Change our Minds.

We can use FMEA to help us make risk-based decisions about our product within changing and evolving use environments and scenarios.

The Designer’s Risk Analysis affects Business, Projects, and Suppliers

It takes a village to produce a design from concept to realization. Everyone along the way seems to think of risk a little bit differently. Designers are both directly and indirectly involved with all these risk management methods, but it’s important to understand who is looking at what type of information. Why? Because of communication. One group…