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Failure Mode & Effects Analysis
Measurement System Analysis
Lean Concepts

FMEA - Failure Mode & Effects Analysis
What is an FMEA?
Failure Mode & Effects Analysis was first introduced in the aerospace industry. It has since become a vital tool to identify components of concept, design or process steps. A list of the potential failures associated with these steps, the possible effects and causes of the failures, and the ability to detect them are determined and rated numerically.
The steps to completion involve a systematic approach to recognizing and evaluating all possible potential failures of a product, process or service. Actions must be identified to eliminate or minimize the cause (best option) or the failure mode.

Failure Mode & Effects Analysis needs to be completed in a timely fashion to ensure successful implementation of actions. The FMEA must happen as a "before-the-fact" proactive technique rather than an "after-the-fact" reactionary must.
Who is involved in FMEA?
The development of a Failure Mode & Effects Analysis should be the responsibility of those involved in the various stages of, as well as anyone else with insight into, the product, process or service.
Types of FMEA
Concept FMEA - looks at system options and helps estimate whether a concept can achieve its desired level of performance.
Design FMEA - looks at design requirements and their alternatives and ties them into the initial design for manufacturing and design for assembly.
Process FMEA - looks at new manufacturing and assembly processes and anticipates potential process failure modes, their effects and causes.
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MSA - Measurement System Analysis
What is Measurement System Analysis?
When identifying sources of variation, one must take into account the 5M's and 1P. They stand for Machine, Method, Material, Measurement, and People. Time and effort are spent on all the sources of variation but often the Measurement System is overlooked.
A quantitative evaluation of the gauges, operators, methods of data collection, etc. used in make numerical observations falls under the banner of a Measurement System Analysis
The main reason that an MSA is performed is to ensure that the data collected is a true representation of the process(es) it has been taken from. There is no room for the GIGO Syndrome (Garbage In, Garbage Out).


Components of MSA (1)

- the larger of the apparent and effective resolutions for single reading systems. A discrimination ratio which describes how many classifications can be reliably distinguished given the observed process variation.
- the difference between the observed average of measurements and the master average of the same parts using precision instruments (gauges).
- the amount of total variation in the system's bias over time on a given part or master part.
- the difference in the bias values of a gauge through the expected operating range of a measuring instrument (gauge).
- variation in the average of the measurements made by the same "measurer" using the same measuring instrument when measuring the identical characteristic on the same part(s).


The term repeatability refers to the inherent variation of the measuring system, which occurs when repeated measurements are made of the same item under absolutely identical conditions (i.e. same operator, same setup, same units, same environmental conditions).
- variation in the average of the measurements made by different "measurers" using the same measuring instrument when measuring the identical characteristic on the same part(s).


The term reproducibility refers to the inherent variation occurs when measurements are made under different conditions, holding all factors constant, and varying only one of either different operators, different setups, different units, different environmental conditions, or different measurement systems.
(1). Taken from Measurement System Analysis - Reference Manual 2nd. Edition, February 1995
Note: Typically, repeatability and reproducibility are the two major components of the measurement system analysis that are focused on more than the others. Reference is made to them as the Gage R&R.
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Lean Concepts
What is Lean?

Lean involves the elimination of waste. Sources contributing to waste can come from methods, materials, machines, measurement or the actual personnel, to name a few. Minimizing waste from one or more of these sources optimizes the returns of the organization, in the form of better quality and increased productivity. But this is not a new concept.

Lean involves tightening the purse strings. The task becomes one of not disrupting the quality of the product, process or service. Only this way will a company be able to continue in this competitive day and age.

As a company strives toward lean concepts, the benefits soon become obvious. The organization is able to withstand economic as well as competitive pressures, without sacrificing quality and service. The bottom line will be satisfied customers and a profitable company.


Who is involved in Lean?

Lean concepts should, like most quality initiatives, involve all areas of an organization. This will insure that everyone is working toward the goals of lean concepts.

Fundamentals of Lean

Lean concepts incorporate three elements. These are: Visual Control, Visual Display, and 5 S (Sort, Stabilize, Shine, Standardize, Sustain). It also utilizes the techniques of Kaizan and error proofing (Poka Yoke).
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What is Reliability?
Customers are the ones who define what quality is - based on their expectations. They want products and services that will meet or exceed their needs and expectations throughout the expected life of the product or service, at a cost they can afford. Reliability is related to the ability of a product or service to perform its desired function for a given life span, and under the operating conditions encountered in a manner that meets or exceeds customer expectations.
The focus is on the probability of maintaining the intended function over time, and is typically measured as a percentage. The measurable are related to the probability of failure in a test or field run. Tied into the measurable is the customers' perception. This perception must then be converted into understandable engineering terms. From this point on, the time to failure can be successfully determined.
An approach
After analysis and diagnosis of the reliability components, requirements need to be defined. From this point on, robustness needs to be designed into the process. Upon completion of the design for robustness, there must be some form of verification. This would lead to sustaining the gains and improving the quality of the product, process or service.
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