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. Whilst 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 is 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 defines:
Intent
Timing
Team Composition
Task Allocation
Tools
Step 2: Structure Analysis
The tools for the structure analysis step are the:
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, 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 of 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 in 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, 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.
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