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Michele E Ellis.
Sr. Quality Engineer
Mykrolis Corporation
915 Enterprise Blvd
Allen, TX 75013
mickiellis@hotmail.com
SUMMARY
So you need to upgrade your QMS to ISO 9001:2000 or TS 16949:2002, but how do you figure out where
to begin, and how do you determine where to allocate your minimal resources first? This presentation will show
you how you can use an FMEA approach to complete your gap analysis while also prioritizing those needs with a
classical RPN number. By assessing the risks to your business against completing the standard requirements, you
can determine where to concentrate your resources first to get the most return on that investment. This is a unique
application of a classical tool which can serve us all well in a resource limited economy.
INTRODUCTION
In this paper, we will see how the classical FMEA model is ideally suited for an assessment of your Quality
Management System. By analyzing each gap in your system with the requirements of either ISO 9001:2000 or TS
16949:2002, you will be able to determine the cause of the gap, the effect of such a gap on your customers and your
business, and also expose your ability to detect such a gap. Using the calculation of the FMEA Risk Prioritization
Number, you will be able to determine where to apply your limited resources first to make the most improvement in
your QMS and subsequently your business.
The major changes between ISO 9001:1994 and ISO 9001:2000 is that the current version of the standard is
Process based. ISO 9001:2000 and TS 16949:2002 encourage the organization to define your QMS as a series of
interconnected processes designed to turn customer requirements into a deliverable product or service. It makes
sense then to use a process based tool to analyze a process based QMS.
FMEA by its nature is process based, i.e. it forces us to examine possible failures or gaps in an
organizations processes.
While the responsibility for preparing an FMEA must, of necessity, be assigned to an individual, FMEA
input should be a team effort.
FMEA by its very nature provides prioritization. The classical RPN (Risk Prioritization Number) can be
used to determine where to: Get the most bang for your buck!
Provides mechanism for documenting necessary actions and keeping track of their status, while also
identifying the persons responsible for making the actions happen.
Translating these definitions into those suitable for assessing gaps in an organizations QMS reveals the
following QMS-friendly definitions:
FM = Failure Mode = Where does my current QMS not measure up to the requirements of ISO 9000:2000
or TS16949:2002
E = Effect = What is the effect to my business or my customers if I am in non-compliance
A = Analyze = Identify the cause of the non-compliance and identify actions which could eliminate this
particular failure
Completing an FMEA of each business process defined in your QMS will then result in a variety of RPN
numbers assigned to each potential failure. Combining each FMEA into one overall FMEA for the organization and
ranking it by RPN will then identify those gaps which are the most dangerous to your organization and should thus
be addressed first. As with a classical FMEA, each gap should be examined to determine the most effective
correction that can be taken by the organization, and then a new RPN may be calculated to determine if this action
will truly be effective. The FMEA template may also be used to document action plans and individual
responsibilities for completion in order to manage the process.
CONCLUSION
FMEA provides an ideal tool for measuring gaps in your QMS due to its process-based nature, its
teamwork philosophy, its inherent prioritization feature, and its ability to provide and maintain status on the
completion of required assignments. In todays resource limited economy, use of this tool will allow an
organization to determine the gaps in its QMS, prioritize them based on risk to the organization and then establish
necessary actions to close the gaps. An organization can then focus on those items which will Give the most bang
for the buck!