top of page

Risk Mitigation Using FMEA: Is Your Organization Taking These Simple Steps?

Updated: Jun 18, 2021

ENCONA | Risk Mitigation Using FMEA

Risk arises from any type of instability in a method or environment. Risk is proportional to the capacity to forecast and foresee its effects. More specifically, it is linked to the potential to eliminate risk in a timely fashion and to mitigate the risk, if it happens despite the apparent preventive interventions. Risks may emerge when delivering products or services to the customers in terms of quality, timeliness, and brand image. The procurement and delivery of goods and services to companies and customers is becoming more dynamic, and with it, the related risk evaluation and management techniques.

Risks can be hard to spot, volatile, and fast-moving. One of the most widely used tools in risk management is Failure Modes and Effects Analysis (FMEA). With the new AIAG-VDA FMEA standard being implemented, it may be daunting for your organization to determine what steps are needed to harmonize your FMEAs. Below are some key points that may assist in this process.


As with any organization, this step takes time. Even during the global pandemic, the #automotiveindustry has remained busy. However, in order to understand the new standard, you must be exposed to the book, The AIAG & VDA FMEA Handbook, to review the concepts presented. Learn about the seven steps of the process as well – Planning & Preparation, Structure Analysis, Function Analysis, Failure Analysis, Risk Analysis, Optimization, Results Documentation – as these steps may not be familiar to you. If this is new to your organization completely, it may be best to develop a core team of those who are most experienced with FMEA to develop a process specific to your organization. This core team will be pivotal to harmonizing the FMEA process across the organization.


If your organization is implementing the AIAG & VDA FMEA harmonized standard, one of the easiest ways to assist with the process is to have a project management board for each step. For example, your first step may be developing a core team, then deciding what software will be used to manage the FMEAs. In any case, give your organization time to sort out the methods that work for you.


Time and time again, FMEAs are not taken seriously by the organization. Root causes are not identified properly, prevention and detection controls are generic and not helpful (i.e. “operator training” as a prevention control), and the risk analysis itself is not effectively managed, including determining the Action Priority (AP) determination and the Optimization steps. Without having adequate support from the top, FMEAs will continue to be taken lightly and auditors will continue to give non-conformities. Leadership must understand that these documents are for understanding and mitigating risks in the design and manufacturing processes. Without leadership support, this becomes another menial task. It is the responsibility of leadership to ensure that risk, in any form, should be minimized as much as possible. Therefore, the time it takes to complete an FMEA, including the support from other Subject Matter Experts (SMEs), must be considered by leadership. The FMEA process should be integrated into most departments, if only for some to have a general concept of its importance to getting the final product to the customer.


The ENCONA team has resources to help you, in-person and virtually, to determine the best way to move forward with AIAG & VDA FMEA harmonization and give your organization a solid foundation for success. This process will be beneficial for your organization’s growth in the long run. With NHTSA reporting over 53 million people impacted by recalls in 2019 alone in the USA, organizations must take risk mitigation seriously, and one of the required tools in the automotive industry is the FMEA. With our strong industry foundational knowledge and implementation of our industrial applications, your organization will have success in the future.

Contact us about our consulting services or view our upcoming courses.

Article contributed by Alecia M. Gabriel

Risk Mitigation Using FMEA: Is Your Organization Taking These Simple Steps?

83 views0 comments


bottom of page