On December 11, 2019, the AIAG published a blog post titled “AIAG Announces OEM Deployment Plan For New AIAG & VDA FMEA Handbook”.
It has now been over four years since the Handbook has been published. Is it the standard? If it isn’t the standard, why isn’t it? If you don’t know the correct answer to these questions, it could cost your company a lot of money.
Design FMEA, Process FMEA and the tools which they are integrated with can be the foundation of a risk-based, fully compliant ISO/DIS 9001:2015 Quality Management System (QMS). For the FMEAs to fulfill their critical role in the QMS, they must be done correctly. The paper identifies common mistakes made when performing the two FMEA types that if made will severely inhibit the effectiveness of the FMEAs as well as the QMS.
On Dec. 7, 2021, Ford Motor Co. updated its IATF 16949—“Customer specific requirements” (CSR), which requires the use of reverse FMEAs (RFMEA) on new equipment (“tooling”). The first sentence of the reverse FMEA requirement reads: “Organizations are required to have a process in place that ensures all new launches complete an RFMEA event once the equipment is installed and running.”
How will this affect your company?
On Dec. 7 2021, Ford Motor updated its IATF 169 “Customer specific requirements” (CSR), which require the use of reverse FMEAs on new equipment (“tooling”). The requirement reads: “Organizations are required to have a process in place that ensures all new launches complete an RFMEA event once the equipment is installed and running.”
How is your company going to handle this requirement? First you need to learn what Reverse FMEAs are – and what they are NOT.
In 2017, McKinsey & Company estimated Direct Costs of Poor Quality in the medical device industry at $18 to $22 billion. In this video we identify the systemic causes of the high medical device Direct Costs of Poor Quality AND their solution.
Since the AIAG FMEA 3rd edition manual was published in July 2001 the current version of the AIAG FMEA manual has been the technical equivalent of the current SAE J-1739 FMEA standard.
This is no longer the case.
Whether your new product is a hybrid vehicle, ketchup bottle or a molecular assay to detect a disease, the use of risk-based thinking is critical to designing products and processes that deliver the maximum benefits at the lowest risk.
Are you are struggling to figure out the new AIAG-VDA FMEA Handbook? You are not alone. We break it down for you here.
The Design FMEA (DFMEA) has been used for many years to manage hardware design risk. This has led to improvements in hardware designs and increased efficiency in their development. Unfortunately, the same cannot be said for using the DFMEA to manage software design risk.
ISO 9001:2015 explicitly requires companies to use risk-based thinking to manage their business.
Numerous examples are provided, including a medical device FMEA.
Design FMEAs and Process FMEAs are point in time assessments of your supplier’s design and manufacturing processes. A twenty-minute review of the two documents will often tell you more than a one-day or two-day onsite audit.
IATF 16949:2016, the automotive international quality standards, requires the use of “Risk-based Thinking” in the management of any process that has an impact on product quality. This paper defines the key steps that must be taken to effectively implement of “Risk-based Thinking” in the design process.
An audit of thousands of FMEAs resulted in 30 common mistakes being identified. This article contains the top 10 FMEA mistakes. Nine out ten FMEAs analyzed had one or more of the top ten mistakes.
The Design FMEA helps companies effectively manage design risk. To accomplish this task, the Severity Rating, Occurrence Rating, Detection Rating and Class column must be properly populated for every line of the Design FMEA. This is part one of a three part article that will explain the most effective way of populating these four columns. It will explain the Severity Rating.
Despite countless training classes and numerous books written on the use of FMEAs, most companies do not perceive them as powerful tools but as something that must be done to meet a quality audit or customer requirement. This article that will explain how you can use FMEAs to create profits and not paper. Note: Originally published in Quality Digest
The Process FMEA (PFMEA) methodology found in the AIAG VDA FMEA handbook is based on a VDA FMEA software program released in 1992. This article will explain what the AIAG-VDA PFMEA methodology is and why it will result in a PFMEA implementation that is inefficient and ineffective in managing manufacturing risk.
The Design FMEA (DFMEA) methodology found in the AIAG VDA FMEA handbook is based on a VDA FMEA software program released in 1992. This article will explain what the AIAG-VDA DFMEA methodology is and why it will result in a DFMEA implementation that is inefficient and ineffective in managing design risk. Note: Published in Quality Digest, January 31, 2018.
If you have attempted and Process FMEA class in your lifetime there is a high likelihood that the instructor has told you to “assume everything from the supplier has been received in spec”. Your experience tells you this is not true in the manufacturing plant. It is not true for Process FMEAs either and this video will explain why.
The Machine Tool Industry has struggled for years trying to implement Risk Based PLM tools. The requirement for their proper implementation has received additional emphasis with the introduction of ISO 9001:2015 and its requirement for the implementation of risk-based thinking when managing the business.
What exactly is a Design FMEA? What is it’s history? How did it come about? In this paper we outline the origin of the Design FMEA and explain why it is a powerful tool for uncovering and managing risk.
The new SAE J1739 FMEA Standard JAN2021 DFMEA Process consists of six steps. This article provides an overview of the contents of each of the six SAE J1739 DFMEA process steps as well as a reference on where to find the comparable information in the AIAG-VDA FMEA Handbook.
The new SAE J1739 FMEA Standard JAN2021 DFMEA Process consists of six steps. This article provides an overview of Step One and where to find the comparable information in the AIAG-VDA FMEA Handbook.
