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FMEA

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3 views

FMEA

Uploaded by

Antonio Mateos
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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FMEA: Definition, Steps,

Types & Tools


Build a foundation on what FMEA is all about and proactively capture
and mitigate risks in your processes
What is FMEA?
Failure Mode and Effects Analysis (FMEA) is a proactive method of uncovering
potential failures in business processes in order to prevent them from
happening or mitigate their effect by finding out where they might occur and
determining their impact. FMEA’s systematic approach to identifying and
addressing causes of failures can help prevent costly manufacturing issues,
improve product quality and service reliability, as well as increase customer
satisfaction.
FMEA Types
There are several types of FMEA and the most common of them are DFMEA or Design FMEA
and PFMEA or Process FMEA. The difference between these two types of FMEA is as follows:

DFMEA
As the name suggests, DFMEA or Design FMEA, is applicable to product design, particularly
during its early stage or end-stage. The goal of DFMEA is to uncover potential failures with
the design of the product that could impact health & safety and the environment, among
others.

PFMEA
PFMEA or Process FMEA pertains to the uncovering of risks within new or existing
processes. PFMEA is done before a new process is implemented or, in the case of existing
processes, is conducted before changes made to old processes take effect. Both scenarios
for doing PFMEA intend to find any risks that could negatively impact the product, quality,
safety, and customer satisfaction.
How to Perform FMEA: 7 Steps

The methodology of FMEA usually involves a brainstorming session


by a team composed of experienced, cross-functional, team
members who are familiar with the business processes and conclude
with a re-analysis of failure risks after corrective actions have been
applied to eliminate or mitigate the risk of failures. Having a
facilitator will be helpful before performing FMEA.

Here is a simple breakdown of how to perform FMEA in 7 steps:


Step 1: Determine What Needs to be Addressed

Is there a new process that is yet to be implemented and it needs to be


reviewed in order to proactively catch issues that may appear down the line?
Do you know if there are current processes or a system of doing things that is
plagued by issues that can’t be solved? Is customer satisfaction down and
there’s a decrease in sales or less demand in services offered? Which unit of
the business is problematic?

Determine which process, system, metrics, or aspect of your business you need
to focus on.
Step 2: Create a Cross-Functional FMEA Team

Build a team composed of members who are very familiar with the aspect of
business that will be worked on. The FMEA team members, lead by a
coordinator, are ideally from different functions and can work together with
the goal of identifying issues that need to be addressed.

Step 3: Lay Down the Process, System, or Steps

Lay down the entire process, system, or steps involved in the problematic
aspect of the business that needs to be worked on. Create a diagram or build a
flowchart that clearly shows and describes the whole process to all team
members.
Step 4: Analyze Each Step and Determine Problem Areas

Check each step in the process and identify areas where problems occur or
could show up (failure modes). Create a list of all the issues from the failure
analysis and clearly describe each of them.

Step 5: Select Which Issues to Prioritize

From the list of issues or failure modes, determine which problems to prioritize by
calculating the FMEA Risk Priority Number (RPN). Designate a rating of 1-10 for the Severity,
Occurrence, and Detection and multiply these three with each other. Do this risk analysis for
all of the items on the list. Seeing the issues with the highest RPN should help you decide
which problem/s to prioritize.
Step 6: Implement the Changes

After you’ve determined which issues to prioritize based on the RPN,


implement the changes that would eliminate or reduce the occurrence or
impact of those problems.

Step 7: Monitor the Implementation of the Changes and Measure their Effectiveness

Ensure that the changes are indeed implemented and have positively impacted your
business. Measure their impact by monitoring the process, system, or steps where the
changes took place and check if the desired result was achieved.
FMEA Tool

Before and after changes are implemented, there needs to be a way to know
what the issues are and if they are being addressed. Safety Culture (formerly
iAuditor) is a powerful tool that can aid teams ensure that changes are indeed
implemented and if they are impacting the business as a whole.

Ideal for teams, Safety Culture is a data-driven platform that can be used
online or offline on your mobile to monitor performance and collect data that
can be analyzed to measure impact. Data collected over time can then be used
for training and continuous improvement to optimize production and further
elevate the quality of products and services.

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