Failure Modes and Effects Analysis (FMEA) is a time-consuming process – even for top-tier manufacturers with the resources to invest heavily in customized IT systems. However, it is also a highly effective process when coordinated the right way. The challenge you face as a quality management professional is how to prepare, coordinate and (when necessary) revise FMEAs to harmonize with your company’s Advanced Product Quality Planning (APQP) and beyond.
Today, too many companies still consider FMEAs as more of an afterthought than a priority (i.e., as just another box to check during APQP and compliance audits). To help you avoid this all-too-common pitfall, this post will walk through you through a refresher on FMEAs in manufacturing and why they need to be a priority.
What Are FMEAs?
Failure Modes and Effects Analysis are a critical part of APQP that creates “living” documents (i.e., documents that you will need to revise and update every so often). Ideally, FMEAs allow you to pinpoint and resolve quality management issues before they occur. FMEAs are also known as a reliability engineering methodology, which may be more familiar to you if you have a background in engineering.
Essentially, there are three main categories of Failures Modes and Effects Analyses commonly used today:
- system FMEAs
- design FMEAs
- process FMEAs
Depending on your company’s position in the supply chain, you may have to pay more attention to one specific type of Failure Modes and Effects Analysis. For example, an up-and-coming supplier to the automotive industry should ideally focus on design and system FMEAs, but which of these add the most value? The major challenge you face is to decide which FMEAs add the most value to your company’s quality management system.
Here’s a list of some of the most common Failure Mode and Effects Analysis guidelines published today:
- Potential Failure Mode and Effects Analysis Reference Manual Fourth Edition, published by the Automotive Industry Action Group (AIAG)
- Potential Failure Mode and Effects Analysis in Design, Potential Failure Mode and Effects Analysis in Manufacturing and Assembly Processes, published by the Society of Automotive Engineers (SAE)
- Analysis Techniques for System Reliability – Procedure for Failure Mode and Effects Analysis, published by the International Electrotechnical Commission
- Recommended Failure Modes and Effects Analysis Practices for Non-Automobile Applications, also published by the SAE
These manuals are a good starting point if you need a refresher on the fine details of FMEA best practices by trusted experts from the AIAG and SAE in the US. In the automotive industry, FMEAs play an absolute critical role in assuring safe products reach consumers. The fast-paced demands of today’s manufacturing industry place even more importance on FMEAs than in the past.
Here’s a quick look at why Failures Modes Effect Analysis are so critical.
What Makes Failure Modes and Effect Analysis So Critical?
If you can catch design, process, or equipment failures before they have a negative – if not catastrophic – effect on your downstream manufacturing operations, the cost to address these failures goes down substantially. The fact of the matter in quality management today is that costs increase mightily as problems occur late in the production process; anticipating problems during product development saves your company time and money.
As a quality management professional, you already know the worst case scenario all-too-well: morbidly expensive global recalls of unsafe, poor quality products that reach consumers and business partners. FMEAs fit into APQP as a tool to assess the risk associated with a particular failure mode (i.e., what could possibly go wrong with a subsystem or assembly). Without a sound, company-wide Failure Mode and Effects Analysis process in place, APQP suffers, which only increases the likelihood of unforeseen problems surfacing late during production.
FMEAs are critical to helping you identify which failures have high severity, a high likelihood of occurring and potentially serious negative impacts. Today’s consumers may demand 110% safe and perfectly reliable products, but this ideal is nearly impossible to achieve. However, FMEAs and APQP give you the chance to come as close to the zero-defect ideal as possible. Think of the way 5S (i.e., the method of ensuring quality is continuously improving) helps companies stay one step ahead of quality issues.
At the end of the day, Failure Modes and Effects Analysis should be a key part of your company’s APQP and cost-containment strategy. Costs rise as quality defects come to light late in the production process. FMEAs give you a tool to identify potential failures, assign risk and move on to corrective and preventative actions.