INTRO:

Problems and defects are expensive. Customers understandably place high

expectations on manufacturers and service providers to deliver quality and
reliability.
Often, faults in products and services are detected through extensive testing
and predictive modeling in the later stages of development. However, finding a
problem at this point in the cycle can add significant cost and delays to schedules.
The challenge is to design in quality and reliability at the beginning of the process
and ensure that defects never arise in the first place. One way to achieve this is to
use failure mode and effects analysis (FMEA), a tool for identifying potential
problems and their impact.

START:
Used across many industries, FMEA is usually created in a spreadsheet and is
one of the best ways of analyzing potential reliability problems early in the
development cycle, making it easier for manufacturers to take quick action and
mitigate failure. The ability to anticipate issues early allows practitioners to design
out failures and design in reliable, safe and customer-pleasing features.

The FMEA process is an on-going, bottom-up approach typically utilised in

three areas of product realization and use, namely design, manufacturing and
service. A design FMEA examines potential product failures and the effects of these
failures to the end user, while a manufacturing or process FMEA examines the
variables that can affect the quality of a process. The aim of a service FMEA is to
prevent the misuse or misrepresentation of the tools and materials used in servicing
a product.

There is not a single, correct method for conducting an FMEA, however the
automotive industry and the U.S. Department of Defense (Mil-Std-1629A) have
standardized procedures/processes within their respective realms. Companies who
have adopted the FMEA process will typically adapt and apply the process to meet
their specific needs. Typically, the main elements of the FMEA are:

It is important to note that the relationship between and within failure modes,
effects and causes can be complex. For example, a single cause may have multiple
effects or a combination of causes could result in a single effect. To add further
complexity, causes can result from other causes, and effects can propagate other
effects.
 Once the participants are together, the brainstorming can begin. When
completing an FMEA, it is important to remember Murphys Law: Anything that can
go wrong will go wrong. Participants need to identify all the components, systems,
processes and functions that could potentially fail to meet the required level of
quality or reliability. The team should not only be able to describe the effects of the
failure, but also the possible causes.
Designers often focus on the safety element of a product, erroneously
assuming that this directly translates into a reliable product. If a high safety factor is
used in product design, the result may be an overdesigned, unreliable product that
may not necessarily be able to function as intended. Consider the aerospace
industry that requires safe and reliable products that, by the nature of their
function, cannot be overdesigned.

The advantage of a numeric rating is the ability to be able to calculate the

Risk Priority Number (RPN) (see Step 9). Severity ratings can be customized as long
as they are well defined, documented and applied consistently.

Note: if a failure rate falls between two values, use the lower rate of
occurrence. For example, if failure is 1 in 5, use a rating of 8.

In general, the failure modes that have the greatest RPN receive priority for
corrective action. The RPN should not firmly dictate priority as some failure modes
may warrant immediate action although their RPN may not rank among the highest.

There is not one single FMEA method. The following steps provide a basic
approach that can be followed in order to conduct a basic FMEA. An FMEA for a car
tire is used to help illustrate the process.

There is no definitive RPN threshold to decide which areas should receive the
most attention; this depends on many factors, including industry standards, legal or
safety requirements, and quality control. However, a starting point for prioritization
is to apply the Pareto rule. As a rule of thumb, it says that teams can focus their
attention initially on the failures with the top 20 percent of the highest RPN scores.

Once corrective actions have been completed, the team should meet again to
reassess and rescore the severity, probability of occurrence and likelihood of
detection for the top failure modes. This will enable them to determine the
effectiveness of the corrective actions taken. These assessments may be helpful in
case the team decides that it needs to enact new corrective actions.
 For our example, let us use Soap Making as an example. Your FMEA team
could include the Quality Control Manager, the Factory Supervisor, the Product
Manager, the Marketing Director, the Cost Accountant and the General Manager.
Take note that they have diverse expertise yet everyones opinion is valuable in the
decision making process. After an imaginary brainstorming, they came up with the
following entries to the FMEA table:
Under the potential failure modes, the team listed three possible failures in
soap making and its respective effects and potential causes. For severity, analysts
can assign severity for the respective failure mode from a low severity of 1 to a high
10. Occurrence is scored in the same manner while detection is scored in reverse. If
a failure is highly detectable, the score is low. Hard to detect failures should be
scored high in detection.
RPN is the product of severity, occurrence and detection. (RPN=S*O*D)
Critical characteristic is mostly optional in many companies because of its
subjectivity. It is the measure of the overall impact of the failure to the company. It
is usually scored Y or Yes if either severity or occurrence is at 9 or 10 and if
detection is higher than 3.

Based on the accomplished table, priority should be on the uniformity of size

because it has the highest RPN and wrong fragrance because of its critical
characteristic. The companys scarce resources will then be channeled to these two
failures.

The next step for the FMEA team would be to come up with action plans to
counter the failures. It is also important to assign ownership or responsibility of the
course of action and define the length of time for the cycle or the period for which
the action plan is to be implemented before another analysis.

Due to the implementation of the courses of action or process control

improvements, the re-assessed occurrence ratings will change. The severity scoring
always stays the same all throughout the cycles unless the company changes its
goals or customer profiling. Detection will also change based on the process
controls implemented but for our example detection remained constant because the
action plans were focused on the occurrence of the problem.

Note that the ratings for the misshapen soaps failure remained the same.
This is because no action plan was implemented to resolve the problem. The
problem on size uniformity has been addressed significantly as it has the biggest
drop on RPN due to the drop on its occurrence.
 Given the results of the Second Cycle FMEA, the failure on misshapen soap
already ranks as the top failure in the soap making process. It is therefore the
priority failure mode and the companys scarce resource will then be channeled to
resolve the problem. You can conduct FMEA analysis periodically to check on the
performance of the process.
END:
Everyone wants to support the accomplishment of safe and trouble-free
products and processes while generating happy and loyal customers. When done
correctly, FMEA can anticipate and prevent problems, reduce costs, shorten product
development times, and achieve safe and highly reliable products and processes.