Failure Modes and Effects Analysis (FMEA) is not just a document creation activity. It is a disciplined risk analysis methodology, which starts with Step 1: Planning & Preparation. According to the AIAG-VDA FMEA Handbook, this step is the foundation for the entire FMEA process.
Planning and preparation ensures that the analysis is structured, focused, and efficient, aligning with both project and organizational goals.
Let’s dive into what this first step involves.
Why Planning & Preparation Is Critical #
Skipping or hurrying in the planning step leads to the complete FMEA with lack in focus, scope, or clarity. It is like creating a document that does not add any value in design or process.
The goal of Step 1 is to define the framework for analysis. what you’re analyzing, why it matters, and how you’ll approach it.
AIAG-VDA clearly explains this step as essential for get to know the “InTent” of the FMEA, making sure your team is working on the right problem, at the right time, with the right people and information.
What Happens in the Planning & Preparation Step? #
Here’s what you should actually do during this step, based on the AIAG-VDA method:
1. Do project planning using 5T in FMEA (Refer 5T worksheet)
This is the important step in project planning and preparation where you need to define your 5Ts (InTent, Timing, Team, Tool, Task).
Refer complete article: The Five Ts in FMEA – Intent, Timing, Team, Task, Tools
Rest we will cover everything about planning and preparation here.
2. Clarify the Purpose of the FMEA
Is this FMEA being done for a new product launch? For a customer requirement? A response to a field failure? You must define the reason why you are doing a FMEA analysis, this is your project’s intent.
Example purposes:
- Prevent potential failures in a new ECU design.
- Fulfill a customer requirement during APQP.
- Evaluate a process change in the welding line.
Clarifying the purpose will help to focus the analysis and achieve a success.
2. Identify the FMEA Scope
Scope defines what is included and excluded in FMEA analysis.
- For Design FMEA, the scope is to do risk analysis of a subsystem such as the motor drive or the seatbelt mechanism.
- For Process FMEA, the scope can be a specific operation e.g., glue dispensing or spot welding.
Consider this as a boundary in which you need to do analysis:
- Product or process boundaries
- Customer interface and internal interfaces
- Relevant system levels
You can visualize and define your scope using a boundary diagram (for DFMEA) or a process flow diagram (for PFMEA).
3. Define Technical Assumptions and Boundaries
The AIAG-VDA method recommends clearly documenting assumptions to avoid misunderstanding during failure analysis.
Examples of assumptions:
- A component will operate in a temperature range of -40°C to 85°C.
- The upstream process provides 100% inspected parts.
These assumptions are helpful and justify the basis of your risk analysis and can be check during audits or reviews.
4. Gather Data & Input Documents
An effective planning step includes collecting and reviewing relevant technical documentation, such as:
- Drawings and CAD models
- Process flow charts
- Specifications and standards
- Lessons learned from previous FMEAs
- Warranty and field return data
- Special characteristics matrix
It is always good that the team have these all relevant data and a complete technical picture before moving to structure or failure analysis.
5. Assemble the Right Cross-Functional Team
Although team roles (the “Team” T) are part of the Five Ts, in this step, the practical action is to identify and involve the right persons, such as design engineers, manufacturing engineers, quality, purchasing, FMEA moderator and customer team as needed.
This helps in:
- Understanding of functions and failure modes
- Accuracy of occurrence and detection ratings
- Validity of recommended actions
6. Decide the Analysis Strategy (Top-Down or Bottom-Up)
Depending on the system complexity and available data, teams may choose:
- Top-down approach: Starting from system to sub-system to components.
- Bottom-up approach: Starting from known failure data or critical parts.
Both are valid and can be used in combination.
7. Plan for Timing and Deliverables
FMEA is most effective when done early and on time, Design FMEA before design freeze and Process FMEA before process launch.
So set:
- FMEA start and end dates
- Milestones for review
- Integration into the APQP timeline
- Version control process
This proactive planning makes sure your FMEA doesn’t become a last-minute compliance task, and done on time.
8. Define Interfaces to Other Quality Tools
This is the step to establish links between FMEA and other tools like:
- Control Plans
- Special Characteristics
- Test Plans (e.g., DVP-R/PV)
- Process Flow Diagrams
- Design Verification Matrix
Integrating tools increases the robustness and practical use of the FMEA and creates a linking documentation structure.
Outputs of Step 1: Planning & Preparation #
At the end of this step, below points should be clear and documented:
- FMEA type: Design, Process, MSR
- Scope and boundaries
- Assumptions and exclusions
- Team members and roles
- Timeline and milestones
- Data sources for analysis
- Linkage to other tools
All of these are inputs for the next steps, such as Structure, function and failure Analysis.
Summary / Key points #
Planning & Preparation is not just a checklist, it’s a strategy phase that decides why you’re doing the FMEA, what it will cover, who will be involved, and how we are going to create it.
When this step is done properly, every hour spent on FMEA adds real value of reducing risk, improving quality, and meet customer expectations.
