What is FMEA?
Failure Modes and Effects Analysis, or FMEA, is an organized
risk identification and mitigation tool.
FMEA uses a systematic process flow to assess potential system failures.
This is done by breaking down the system or process under investigation
into smaller Focus Elements and asking the following questions:
1) HOW does the Focus Element fail to fulfil its primary function? I.e., what are the
Failure Modes?
2) WHAT effects does the Failure Mode have on the internal and/or external customers?
I.e., what are the Failure Effects?
3) WHY does the Failure Mode occur? I.e. what are the Failure Causes?
Source: AIAG/VDA FMEA Handbook (2019)
The Failure Modes and their Effects and Causes are further analysed by determining the:
1) Severity (S) of the Failure Effects → How bad is it for the customer?
2) Occurrence (O) of the Failure Causes → How often does it occur?
3) Detection (D) of the Failure Modes and/or Causes → Do we know when it occurs?
The Severity, Occurency and Detection are scored on a ten-point scale using special
reference tables. Multiplication of the S, O and D scores gives us the total Risk Priority
Number (RPN), with higher values indicating higher risk. As the RPN is not entirely
objective (different combinations of S x O x D can give the same RPN), the so-called
Action Priority (AP) has been introduced as well. The AP uses a reference table to assign
High (H), Medium (M) or Low (L) action priority to each RPN.
To conclude, the FMEA methodology helps us developing a plan to detect, prevent, and/or
mitigate those risks deemed most critical. Overall, FMEA studies provide an invaluable
approach for maintaining and improving our customer satisfaction objectives. This is why
FMEAs consistently remain one of the most used methodologies in corporate product &
process reliability and quality efforts.
Why FMEA in AN?
The FMEA methodology is a mandatory requirement for the
IATF16949 certification needed to be a supplier to the Automotive
Industry. Unsurprisingly, our Automotive & Specialty Coatings (ASC)
organization is a frontrunner within AkzoNobel in implementing the FMEA
way of thinking. In ASC, FMEA is integrated in the complete value chain from
designing new products and application processes in R&D to manufacturing
those products in our plants. For R&D, this means that building and maintaining
FMEA capability in all product development teams around the globe is a key priority.
Although FMEA is not widely used outside ASC yet, it holds great potential to improve our
product lifecycle processes throughout all business units.
How is FMEA applied in R&D?
As explained, the FMEA methodology aims at analysing the risks associated with systems
or processes. Within R&D, a system is typically a new product that is being designed to
meet its customer requirements. The associated FMEA type is referred to as Design FMEA
or DFMEA. A DFMEA basically has three prerequisites:
1) The customer requirements of the new product are known;
2) The key formulation components are known (e.g. binder, solvent, pigment, etc.);
3) The functions of all key components are known (i.e. why is this component used?)
Customer requirements are commonly established by the Marketing teams, whereas key
design components and their functions can be obtained through a System FMEA (or
SFMEA) study. In R&D, however, the Quality Function Deployment (QFD) methodology is
used to obtain all required inputs for DFMEA studies. An Excel template is available for
performing the QFD and subsequent DFMEA studies in new product development.
Another FMEA type used within AkzoNobel is the Process FMEA or PFMEA, which works
on a well-defined process. PFMEAs are commonly used in manufacturing to mitigate the
key risks associated with the scale-up and production processes. In R&D, the so-called
Application FMEA or AFMEA is used, which is similar to the PFMEAs used in
manufacturing, but then focused on optimising the (spray or other) application process.
The AFMEA uses insights from the DFMEA and is especially relevant for setting up our
customers for successful use of our products.
The FMEA methodology is integrated with our StageGate process as illustrated on the next
page. In essence, the QFD is being performed in the Scoping and Feasibility & Justification
phases and can sometimes be extended into the Creation phase. That is also the phase
where the DFMEA and AFMEA are performed, before doing the PFMEA in manufacturing
in the Scale-up & pre-launch phase.
As new product development through the StageGate process involves multiple functions
and departments, it is essential to have clear expectations on ownership and involvement
of stakeholders. The following RASCI table illustrates which roles should be involved in
QFD and FMEA deployment. In summary, new product development is triggered by
Marketing, with the Product Manager assigning a Project Manager to start the QFD. When
the customer requirements are established, the R&D Technical Lead has to make sure the
content part of the QFD is performed by a capable team of R&D experts. The subsequent
FMEA studies are to be triggered by the Project Manager and executed under the
responsibility of the: Technical Lead for the DFMEA; Application Manager for the AFMEA;
ISC Quality Manager for the PFMEAs.
FMEA history
End 1940s The FMEA methodology is developed by the US Military
Early 1960s FMEA is widely used in NASA programs including Apollo & Voyager
Mid 1960s FMEA is adopted by the Civil Aviation Industry
Early 1970s Adoption by other industries, including the Offshore & Food Industries
Mid 1970s Adoption by the Automotive Industry, initiated by Chrysler, Ford & GM
1993 First FMEA standard by the Automotive Industry Action Group (AIAG):
- QS9000 standard for automotive production and its suppliers
1999 QS9000 becomes ISO/TS16949 (Automotive Standard)
2016 The International Automotive Taskforce (IATF) launches IATF16949
2019 New AIAG/VDA FMEA Handbook for the Automotive Industry
(“purple book”)
