Failure Mode & Effect Analysis (FMEA)
Introduction
The purpose for FMEA is to identify the product’s function and process steps along with their respective potential failure mode, effect and causes. And FEMA is generally refer to product function or manufacturing process steps to perform the risk evaluation.
In addition, FMEA also evaluates the sufficency of existing prevention and detection actions. If it is insufficient, then recommended actions can be implemented.
The following list summarize what FMEA emphasize on for product development:
- Improve product quality, reliabiity, safety, service level and production feasibility.
- Obtain assembly, component's structure and assembly compatibility.
- Reduce warranty and nonconformance costs
- Verify product/process risks to prepare potential legal responsibilities.
- Reduce latter change frequency during product development.
- Release product with no defects/flaws.
- Ensure proper communication between internal/external customers.
- Ensure all compliance factors are considered for product design.
- New material source - from existing supplier or new found suppliers
FMEA shall be applied based on the following conditions:
- New Design, Technology or Process
- Existing Design/Process for New Application
- Engineering Change for existing Design/Process
Before evaluting the Design & Process FMEA, 5T’s shall be considered (see below):
Based on APQP’s timeline, the design and process FMEA’s completion shall refer to the following description:
Before breaking down the differences between design and process FMEA, the following diagram will show the general flow of how FMEA is formulated with these 7 steps:
FMEA Planning & Preparation
Generally in the FMEA’s planning & preparation phase, the purpose is to define the scope for the respective FMEA. In addition, confirmation and planning of objects along with scope boundaries shall bode well for the structural analysis within the product.
The following questions can help to define the scope of DFMEA
- WHAT product is the customer purchasing from us?
- Does customer or internal function require DFMEA?
- Do we MANUFACTURE the product while having the DESIGN OWNERSHIP?
- Do we PURCHASE the product while having the DESIGN OWNERSHIP?
- Do we PURCHASE the product while NOT HAVING the DESIGN OWNERSHIP?
- Who is responsible for the joint design?
- Do we need to analyze aspects such as SYSTEM, SUB-SYSTEM, COMPONENT level?
For DFMEA, lesson learnt from previous product development can be applied to define the proper scope boundary along with structural analysis. But for PFMEA, more concrete input can be considered for the scope boundaries.
The following items can be considered to confirm the PFMEA boundary scope:
- Regulation/Compliance Requirement
- Technical Requirement
- Expectations & Needs from External/Internal Customers
- Diagrams (Block, Boundaries, System)
- Drawing or 3D rendering
- Bill of Materials (BoM) and risk evaluation
- FMEA for similar product
- Quality Function Deployment (QFD)
FMEA Structural Analysis
The purpose for structural analysis is to break down design into levels such as system, sub-system, component level and technical risk analysis.
In addition, the design structural analysis’ objectives are:
- VISUALIZE analytical scope
- Structure tree or others such as Block Diagram, Boundary Diagram, Numeric Model or Actual Component...etc.
- Design Connection, interaction and gap identification.
- Collaboration between customer and supplier's engineering team.
- Foundation of function analysis.
The following items can be considered to confirm the process FMEA boundary scope: