Outcome 6 Quality Management System
Outcome 6 Quality Management System
System
DMAIC
DMADV
Software FMEA
Steps of FMEA
Step 1: Planning & Preparation
In Planning & Preparation, the team defines the purpose and definition
of the scope, sets boundaries of the analysis (what needs to be included
or excluded), and establishes the foundation for the entire FMEA
process.
Step 2: Structure Analysis
In Structure Analysis, the system structure is further clarified for technical analysis.
The boundaries set up in Planning & Preparation are analyzed to identify which
systems, sub-systems, and/or components will be part of the FMEA.
Additional tools to support the Structure Analysis are provided such as a structure
tree, block diagram, boundary diagram, flow diagram, or other visualization tools.
Step 3: Function Analysis
In Function Analysis, the product and process functions are explored as well
as the criteria on how to evaluate the performance of functions.
The system elements done in the Structure Analysis are individually
analyzed of its functions and corresponding requirements.
Step 6: Optimization
In Optimization, the team develops a plan of action to mitigate
risks and assess the effectiveness of the optimization actions.
Actions are divided into 2 categories: prevention and detection.
Assignments of responsibilities and deadlines are given.
After actions have been performed, the team reviews the results
to rescore the risks.
Step 7: Result Documentation
In Results Documentation, the FMEA is summarized, documented,
and communicated to the team and stakeholders.
The FMEA report includes summary of scope, identification of high-
risk failures, the corrective actions taken and their effectiveness, and
insights/plans for current and future processes.
The results documentation is to summarize and communicate the
results of the FMEA activity.
Quality Function Deployment – An
Introduction
The average consumer today has a multitude of options
available to select from for similar products and services. Most
consumers make their selection based upon a general
perception of quality or value. Consumers typically want “the
most bang for their money”.
In order to remain competitive, organizations must determine
what is driving the consumer’s perception of value or quality in
a product or service. They must define which characteristics of
the products such as reliability, styling or performance form the
customer’s perception of quality and value.
Many successful organizations gather and integrate the Voice
of the Customer (VOC) into the design and manufacture of
their products. They actively design quality and customer
perceived value into their products and services. These
companies are utilizing a structured process to define their
customer’s wants and needs and transforming them into
What is QFD?
• Quality Function Deployment (QFD) is a process and set of tools
used to effectively define customer requirements and convert
them into detailed engineering specifications and plans to
produce the products that fulfill those requirements.
• QFD is used to translate customer requirements (or VOC) into
measurable design targets and drive them from the assembly
level down through the sub-assembly, component and
production process levels.
• QFD methodology provides a defined set of matrices utilized to
facilitate this progression.
QFD was first developed in Japan by Yoji Akao in the late 1960s while working for Mitsubishi’s shipyard. It was
later adopted by other companies including Toyota and its supply chain. In the early 1980s, QFD was
introduced in the United States mainly by the big three automotive companies and a few electronics
manufacturers. Acceptance and growth of the use of QFD in the US was initially rather slow but has since
gained popularity and is currently being used in manufacturing, healthcare and service organizations.
Why Implement Quality Function
Deployment?
• Effective communication is one of the most important and
impactful aspects of any organization’s success.
• QFD methodology effectively communicates customer needs
to multiple business operations throughout the organization
including design, quality, manufacturing, production,
marketing and sales.
• This effective communication of the Voice of the Customer
allows the entire organization to work together and produce
products with high levels of customer perceived value.
How to Implement Quality Function
Deployment?
The Quality Function Deployment methodology is a 4-phase
process that encompasses activities throughout the product
development cycle. The four phases of QFD are:
1.Product Definition
2.Product Development
3.Process Development