Background
Failure Mode and Effects Analysis (FMEA) is a common methodology used in manufacturing and engineering to identify all possible failures in design, manufacturing, and assembly processes, or in a product or service. It emphasizes presentation and prioritizes risk reduction. While the origins lie in the military, over time the automotive industry has set the standard for FMEAs, and many other industries have adopted the automotive industry’s risk analysis best practices.
The automotive industry quality standard guidelines have primarily been provided by two leading organizations: the Automotive Industry Action Group (AIAG), based in the United States, and the Verband der Automobilindustrie (Association of the Automotive Industry) (VDA), based in Germany.
The increasingly globalized economy has made it easier than ever for manufacturers to source supplies and components from anywhere in the world. But having two sets of FMEA methodologies created inefficiencies that detracted from progress. For example:
Suppliers serving manufacturing customers in both North America and Germany were required to conduct different assessments for the same parts depending on where those parts would be used.
Similarly, when manufacturers audited their different suppliers, they received different scoring systems depending on geography. This made it challenging and time-consuming to compare supplier practices and assess risk.
Overall, having two sets of “standards” led to confusion and added complexity to product and process improvement activities for suppliers and manufacturers globally.
Both the AIAG & VDA historical methodologies have succeeded to a great degree and resulted in quality improvements, but the harmonized standard, developed with a global team of automotive OEM & Tier 1 Supplier subject matter experts, incorporates best practices from both into a structured approach. This approach enables suppliers who supply their products to both European and American customers to use a uniform basis for performing FMEA, eliminating the additional effort of two different procedures and making it easier for suppliers to meet their customers' needs during the FMEA development process.
The AIAG & VDA FMEA Handbook (first published in June 2019) is the automotive industry reference manual for a global standard and guide to assisting suppliers in the development of Design FMEA, Process FMEA, and Supplemental FMEA for Monitoring and System Response.
The handbook provides consistent direction and guidance to all automotive suppliers and features "The 7-Step Approach" for FMEA development, the introduction of Supplemental FMEA for Monitoring and System Response (FMEA-MSR), and an increased focus on function-based FMEAs, amongst other updates to the separate methodologies previously used.
The 7-Step Approach is Outlined Below:
--- SYSTEM ANALYSIS ---
Step 1: Planning & Preparation
The key question at this point is always: "What is the purpose of the FMEA?". Then:
"Do we want to design or modify a component?" (resulting in a Design FMEA)
OR "Do we want to develop or modify a process?" (resulting in a Process FMEA)
There is also a Monitoring & System Response (MSR) FMEA, which is highly specialized and used by a relatively small number of teams, so this article will primarily refer to DFMEAs and PFMEAs.
A core tool used in Step 1 is "The 5 Ts" which define:
Intent
Timing
Team Composition
Task Allocation
Tools
Step 2: Structure Analysis
The tools for the structure analysis step are:
Structure Tree
Block Diagram (for DFMEAs)
The considered product is divided into the System, Subsystem, and Components
Process Flow Diagram (for PFMEAs)
The process is divided into Process Steps and Process Cause Elements (Human, Machine, Method, Material, Environment, and Management).
and the Form Sheet
Step 3: Function Analysis
In this step, the FMEA responsible person has various tasks, including describing the "what" based on requirements and specifications and creating an overview of the functionality of the product or process. These functions must be assigned to a relevant system element.
The tools for the Function Analysis are the same for both DFMEAs & PFMEAs and are:
Function Network
P Diagram
and the Form Sheet
--- FAILURE ANALYSIS & RISK MITIGATION ---
Step 4: Failure Analysis
DFMEAs describe design failures.
PFMEAs describe production or process failures.
Failures are identified based on functions. Failures manifest themselves in many different ways, including:
No function (e.g. failure to operate, sudden failure)
Limited function (e.g. power or performance decreases over time)
Intermittent function (function works/works not/works, etc.)
Fluctuating output (output varies over time, random fluctuation)
Hyperfunction (e.g. operation above permissible threshold)
Unintended function (e.g. operation at the wrong time, in the wrong direction, intermittent function)
Remaining at a certain value
Incorrect direction
etc
Error analysis includes the identification of causes and effects and their interrelationships as well as potential errors. The harmonized approach follows the previous VDA sequence:
Consequence
Error
Cause
To perform and document the Failure Analysis, the following tools are used:
Failure Network
and the Form Sheet
Before the AIAG & VDA Harmonized FMEA, the severity, frequency of occurrence, and detectability of problems were all weighted equally; however, moving forward, the greatest weight is placed on the severity of the problem, then the frequency of occurrence, and finally the detectability. Therefore, the harmonized methodology prioritizes addressing severe issues, even if they occur relatively infrequently and are easy to detect, over less dangerous problems that may occur more often or are more difficult to detect.
Step 5: Risk Analysis
An important point in connection with the risk analysis is the distinction between actions:
Preventive Actions are all actions and activities taken BEFORE a failure occurs.
Detection Actions are all actions and activities taken AFTER a failure has occurred.
As a general rule, preventive actions must be given priority over detection actions for all FMEAs. The resulting FMEA Action Tables indicate the need for action at three levels:
High - measures must be taken or a justification must be provided, and in some cases, management is mandated to review the recommended measures.
Medium - measures should be taken or a justification must be provided.
Low - measures can be taken.
Step 6: Optimization
An FMEA becomes a "living document", utilizing multiple tools to document improvement measures:
Every optimization task must follow the PDCA cycle: Plan, Do, Check, Act - and, if necessary, make adjustments, then plan again, etc.
The objective of every optimization action must be SMART: Specific, Measurable, Attainable, Realistic, and Timeframe. This makes objectives achievable and verifiable.
All actions are recorded in the Form Sheet, including details of the person responsible, the target completion date, and the current status. The effectiveness of the actions must be verified before a re-evaluation can be performed.
--- RISK COMMUNICATION ---
Step 7: Documentation of Results
The following must form part of the evidence and archiving documentation, both internally and externally, for customers:
Planning Document
Scope of Analysis
Definition of Function
Definition of Failures
Rating
Action Plan
The main objectives here are to communicate the results and conclusions of an FMEA to management, to communicate with the customer or supplier, and, if necessary, to identify a basic FMEA as the basis for new projects.
Conclusion
The harmonized AIAG & VDA FMEA method has ensured a uniform and universally valid standard of FMEA in the automotive industry.
Do all FMEAs need to change? No - existing FMEAs can be left in their original form. However, new projects should always be based on the new standard.
Why is this important?
Adopting the new harmonized FMEA methodology, which incorporates AIAG standards alongside VDA standards, ensures the following:
Global Standardization
With the automotive industry being highly globalized, it's crucial that manufacturers and suppliers who operate across various regions all see eye to eye.
Therefore, adopting a harmonized standard for FMEA can ensure consistency and compatibility across various companies' processes and documentation across the globe.
This ensures more streamlined communication and collaboration among all stakeholders in the industry and reduces confusion and errors.
Enhanced Risk Management
The FMEA methodology is a critical tool for identifying and mitigating potential failure modes in automotive components and systems. The AIAG standards combined with the VDA standards help to ensure that previous versions of these codes are improved through an enhanced and more comprehensive approach to risk management.
This helps to emphasise the evaluation of the severity, occurrence, and detection of failure modes, ultimately creating a more robust and risk-averse practice within the industry.
It provides automotive manufacturers and suppliers with greater capability to be proactive about addressing issues before they lead to costly recalls and safety hazards.
Improved Supplier Relations
The vast network of suppliers who service the automotive manufacturing sector can be unwieldy without having the right kinds of standards and codes in place to govern them.
Ensuring that a certain level of quality is achieved across all components and materials requires that the AIAG standards and VDA standards, insofar as FMEA methodology is concerned, are standardized so that relations with suppliers can be strengthened and clear expectations and requirements for quality and risk management can be established.
Through these standards, suppliers can demonstrate their commitment to excellence and, therefore, better align themselves with the processes and expectations of their customers.
Compliance With Industry Expectations
The automotive industry is highly regulated for safety and is constantly evolving to incorporate new technologies.
This means increasingly stringent governance is required, where companies need to adapt their quality management practices to meet increasingly high standards of expectation set through the combined VDA and AIAG standards.
The harmonized FMEA methodology helps to reflect the latest best practices and methodologies for failure analysis and prevention.
Players in the automotive sector benefit greatly from adopting this harmonized approach, as it demonstrates to consumers the commitment to continuous improvement and helps industry participants remain ahead of regulatory changes to stay competitive.
How ENCONA Can Support You
ENCONA runs multiple instructor-led training sessions, both online and in-person, and in-house for groups of delegates upon request.
Our most popular FMEA courses include:
The VDA accredited ID442: VDA & AIAG Harmonized FMEA Basic Training, which aims to teach the basics of FMEA and to give practical tips for application. It is ideal for beginners and prospective users of this method from product & process development, testing, logistics, manufacturing, inspection planning, maintenance, and quality.
The EAC Core Tools I (APQP, FMEA, PPAP) Compact Training, which shows how the issues in individual phases of automotive projects are designed, how specific deployment of methods supports the achievement of planned results, and how the methods are deployed correctly and efficiently. This course is appropriate for all personnel in project teams for product and process design and development, especially from the areas of planning, preproduction, test and inspection planning, and quality.
Contact us at enquiries@encona.org - we enable growth through state-of-the-art delivery of training and production systems.
About The AIAG & VDA Harmonized FMEA Methodology and The 7-Step Approach
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