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ETQ, part of Hexagon, is the leading provider of quality, EHS and compliance management SaaS software, trusted by the world’s strongest brands. More than 600 customers globally, spanning industries such as pharmaceuticals, electronics, heavy industry, food and beverage, and medical devices, benefit from ETQ to secure positive brand reputations, enable higher levels of customer loyalty and enhance profitability. ETQ Reliance offers built-in best practices and powerful flexibility to drive business excellence through quality. Only ETQ lets customers configure industry-proven quality processes to their unique needs and business vision. ETQ was founded in 1992 and has main offices located in the U.S. and Europe. To learn more about ETQ and its various product offerings, visit www.etq.com.
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Filling the Gap
These standards are primarily driven by the original equipment manufacturers (OEMs) that make systems or components for their finished products. It’s important for OEMs to have a single standard for all suppliers to drive towards rather than attempting to track and enforce multiple standards.
Rheem credits Reliance with helping the company overcome many business disruptions. Specific examples include:
Rheem Manufacturing Company was founded in California in 1925. Throughout its early years, Rheem manufactured a number of different products including shipping containers, household appliances, semi-conductors, musical instruments and more. Now, it is the only manufacturer that produces heating, cooling, water heating, pool/spa heating and commercial refrigeration products while remaining the largest manufacturer of water heating products in North America.
Rheem’s focus on industry-leading innovations and energy efficiency has won the company many awards and accolades in the heating and cooling industry. Although the company is headquartered in Montgomery, Alabama, it has locations all over the world to help serve customers on a global scale. The company takes pride in its missiovn to keep people cool in the summer, warm in the winter and enjoying hot water year-round.
About Rheem
Automotive Industry Action Group (AIAG)
German Association of the Automotive Industry (VDA)
The FMEA Handbook, which is often referred to as the ‘Blue-Red Standard’
Table of Contents
FMEA Today
automating fmea
fmea - failure modes effects analysis
how to transition to new fmea standards
In 2019 when the U.S. Department of Commerce was asked to evaluate the impact of shutting down the US/Mexico border, Rheem used Reliance to quickly build a survey sent to Mexican suppliers, helping determine the company’s level of risk quickly should the shutdown occur.
In 2020 when the COVID pandemic hit, Rheem needed a solution to approve suppliers and parts rapidly. Using Reliance, they created an emergency PPAP within the existing PPAP, allowing a fast-track way of approving parts and suppliers.
When the EPA announced that certain chemicals could no longer go into production, Rheem used Reliance to deliver a risk survey to suppliers, allowing them to assess the company’s own risk — within days of the announcement
There are stand-alone tools available that have been configured to meet FMEA standards. These tools typically have simple and familiar interfaces that make them easy to adopt and use.
However, these tools typically lack linkages to enterprise-level solutions. This makes it difficult to share information and prevents data consistency. “If you want to create standard terminology or share information between plants, divisions, or even across parts, it becomes very difficult with a siloed solution,” Vitek adds.
Instead, he suggests making FMEA part of a higher-level enterprise solution. To maximize efficiency, Sandalwood has placed the FMEA product on top of an enterprise quality management system (EQMS) solution.
FAQ
Failure mode effects analysis (FMEA) provides a framework designed to help organizations to perform a thorough risk analysis and identify failure points in product design and production processes.
While FMEA initially began with the automotive industry, it has since expanded into other discrete manufacturing sectors. Today, FMEA standards are part of a broader quality initiative that seeks to prevent failures before they occur.
What is FMEA?
The current FMEA standards have primarily been defined by organizations, including:
FMEA Today
MIKE VITEK,
director at Sandalwood Engineering and Ergonomics
We’re recommending for our customers and people in our advisory group to migrate as quickly as they can. It’s going to happen, so we want to ensure that everyone we’re dealing with is prepared.”
“
“We’ve tried to make those Excel interfaces work. But every time we add a row or a column or move a file, those links break down. It just doesn’t work. It’s an administrative nightmare."
“
Mike Vitek,
director at Sandalwood Engineering and Ergonomics
Automating FMEA
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FAQ About the New FMEA Standards
What is the state of Failure Mode & Effects Analysis (FMEA) today?
Manufacturers also put their own spin on these standards. An increasing number of organizations are driving towards the VDA standard, which is newer and largely process-driven. They are also demanding that their suppliers comply with this standard.
Who must comply with these standards?
What are the consequences of not complying?
Maintaining multiple standards or failing to comply will create difficulties for organizations, as reliability and quality are likely to suffer. Manufacturers that fail to comply with these standards can also be locked out of working with some organizations.
For instance, automobile manufacturer Ford Motor Company is already providing compliance deadlines for the end of the year. Several other organizations are also considering putting their own deadlines in place.
“We’re recommending for our customers and people in our advisory group to migrate as quickly as they can,” says Mike Vitek, director at Sandalwood Engineering and Ergonomics. “It’s going to happen, so we want to ensure that everyone we’re dealing with is prepared.”
How are manufacturers and OEMS dealing with the flexibility in ISO standards?
Many organizations are trying to power through using Excel-based solutions because they are comfortable navigating a spreadsheet.
However, managing complex FMEA requirements in spreadsheets or stand-alone applications is not feasible in the long term. This is because it requires additional capabilities – such as creating linkages between forms – that Excel was not designed for.
Instead of crafting existing solutions haphazardly, organizations should take the time to determine how they’ll deal with these standards internally and devise a concrete plan. Unfortunately, many organizations only realize that they are no longer in compliance when they get to a particular audit.
No, it is not. However, it is important that you don’t try to switch to a new tool and a new standard at the same time. Vitek explains, “If you don’t understand the process and you try to implement a new tool, it can be problematic.”
Instead, Vitek recommends that organizations become familiar with the standard, understand the process, and choose a tool that fits their needs.
He emphasizes that while Excel remains the most commonly used tool for FMEA, it is not a good solution. Many large organizations are beginning to need new and enhanced versions of FMEA that deliver more than Excel.
“We’ve tried to make those Excel interfaces work. But every time we add a row or a column or move a file, those links break down. It just doesn’t work. It’s an administrative nightmare.”
Is it complicated to move from Excel to the new standard??
What other tools are available to do FMEAs?
Over the past couple of years, many organizations have been forced to make cuts and tighten their budgets. One of the key ways they are doing this is through analyzing their workflows and searching for ways to become more efficient. This enables them to pinpoint where redundancies exist and find out where employees are being taxed the most.
Today, there are lots of tools available to help organizations to automate FMEAs and take advantage of workflows and integrations. Leveraging these tools means that employees do not have to do as much extra legwork, which saves money.
Why is now the right time for organizations to consider automating their FMEAs?
Many of the results and output from an automated FMEA process drive critical aspects of quality management. Therefore it is essential to FMEA with quality workflows like asset management, change management, and supplier quality processes that are part of a fully integrated QMS solution.
Why would you position process FMEA and control plans within a quality management system (QMS)?
AN INTEGRATED APPROACH
One of the key benefits of this integrated approach is having common terminology for things such as failure modes, causes, and recommended actions. It also provides a set of standards that people can use to score consistently between plans, parts, and solutions. This solution allows your data to mature within an FMEA, which is what the VDA standard promotes.
“This is very important – especially when you’re starting to look at things like audits, or you start to have people who are looking at your paperwork from afar. It’s important that they see that consistency,” says Vitek
What are some of the benefits of this integrated approach? Can you also talk about some of the data that gets shared?
Yes, it is. And a modern FMEA solution should be compatible with the latest version of the standard while also providing a safety net for those who may be slow to adopt the newest standards.
This current VDA-AIAG standard is applicable to a subset of the market. However, the previous version of FMEA is still applicable broader, is it not?
As of right now, it does not cover functional safety. We have focused on the first application: compliance with VDA and compliance with some of the automotive OEM standards with very specific requirements, such as those from Ford Motor Company.
Does this FMEA solution cover the ISO 26262 functional safety standard?
FMEA - Failure Mode Effects Analysis
The new FMEA standards have been shaped by recent economic downturns that have led many people to leave the automotive industry and move to adjacent markets such as defense, pharmaceutical, and medical.
“The transition to the AIAG and VDA standards is a journey. I would encourage those of you who are considering it to learn as much as you can about the process first and look at what those gaps are in your own process. Once you’ve got an understanding of that, then it’s likely that a tool like the one we have created would be a very good fit for you,” explains Vitek.
“It’s a journey, and starting where you should is always important. When it comes to planning the way along, where we can help with that, then we will.”
ETQ provides the means to integrate FMEA-based risk management into an enterprise quality management framework. ETQ Reliance is a QMS made up of 42 different applications. FMEA is one of those applications that is a part of the New Product Introduction Application Set.
Learn more about transitioning to the new FMEA standards
“We’ve tried to make those Excel interfaces work. But every time we add a row or a column or move a file, those links break down. It just doesn’t work. It’s an administrative nightmare."
“This is very important – especially when you’re starting to look at things like audits, or you start to have people who are looking at your paperwork from afar. It’s important that they see that consistency.”
Mike Vitek,
director at Sandalwood Engineering and Ergonomics
“
MIKE VITEK,
director at Sandalwood Engineering and Ergonomics
The transition to the AIAG and VDA standards is a journey. I would encourage those of you who are considering it to learn as much as you can about the process first and look at what those gaps are in your own process. Once you’ve got an understanding of that, then it’s likely that a tool like the one we have created would be a very good fit for you,
“
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