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FMEA (Failure Mode and Effects Analysis)

Failure Mode and Effects Analysis (FMEA) is a systematic team

driven approach that identifies potential failure modes in a system,

product, or manufacturing / assembly operation caused by either

design or manufacturing / assembly process deficiencies.

It also identifies critical or significant design or process characteristics

that require special controls to prevent or detect failure modes.

FMEA is a tool used to prevent problems from occurring.

Failure modes and effects analysis (FMEA) is a step-by-step approach

for identifying all possible failures in a design, a manufacturing or

assembly process, or a product or service.

Failure modes means the ways, or modes, in which something

might fail. Failures are any errors or defects, especially ones that

affect the customer, and can be potential or actual.

Effects analysis refers to studying the consequences of those

failures.

Failures are prioritized according to how serious their consequences

are, how frequently they occur and how easily they can be detected.

The purpose of the FMEA is to take actions to eliminate or reduce

failures, starting with the highest-priority ones.

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Failure modes and effects analysis also documents current knowledge

and actions about the risks of failures, for use in continuous

improvement.

Ideally, FMEA begins during the earliest conceptual stages of design

and continues throughout the life of the product or service.

When to Use FMEA

When a process, product or service is being designed or redesigned,

afterquality function deployment.

When an existing process, product or service is being applied in a new

way.

Before developing control plans for a new or modified process.

When improvement goals are planned for an existing process, product

or service.

When analyzing failures of an existing process, product or service.

Periodically throughout the life of the process, product or service

FMEA Development

FMEAs are developed in three distinct phases where actions can be

determined. It is also imperative to do pre-work ahead of the FMEA to

assure that the Robustness and past history are included in your analysis.

Step 1 is to determine all failure modes based on the functional

requirements and their effects. If the severity of the effect is a 9 or 10

(meaning safety or regulatory in nature) actions are considered to

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change the design or process by eliminating the Failure Mode if

possible or protecting the customer from the effect.

Step 2 adds causes and Occurrences to each Failure Mode. This is the

detailed development section of the FMEA process. Reviewing the

probability or occurrence number in order of the highest severity and

working downwards, actions are determined if the occurrence is high

(> 4 for non safety and regardless of occurrence >1 when the severity

is 9 or 10)

Step 3 considers testing, design verification and inspection methods.

Each combination from steps 1 and 2 which are considered at risk

requires the detection number to be selected. The detection number

represents the ability of planned tests and inspections at removing

defects or excite failure modes to fail.

FMEA cycle:

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FMEA Working Model

e.g.

How can FMEA be used to reduce the risk of medication errors? To cite one

example, a multidisciplinary committee could use FMEA to assess new

drugs being considered for the formulary. Heres how the process would

work .

Step 1: The committee would explore how the intended product would be

procured and used, from acquisition through administration. Who would

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prescribe the drug and for what type of patient? Where would the drug be

stored? Who would prepare and dispense it? How would it be administered?

Step 2: Potential failure modes (how and where systems and processes may

fail) would be identified while considering how the product would be used.

Could the drug be mistaken for another similarly packaged product? Does

the label clearly express the strength or concentration? Does the name sound

or look like another drug on the formulary? Are dosing parameters complex?

Is the administration process error prone?

Step 3: Once failure modes have been identified, staff would determine thelikelihood of a mistake occurring and the potential consequences of an error.

What would happen to the patient if the drug were given in the wrong dose,

at the wrong time, to the wrong patient, by the wrong route, at the wrong

rate or at the wrong time?

Step 4: Staff would identify any preexisting processes in place that could

help detect the error before it reaches the patient, and evaluate their

effectiveness based upon knowledge of human factors.

Step 5 : If failure modes could cause errors with significant consequences,

actions would be taken to prevent the error, detect it before it reaches the

patient, or minimize its consequences. A few examples include using an

alternative product; preparing the drug in the pharmacy; standardizing drug

concentrations, order communication and dosing methods; using auxiliary

warning labels or computer alerts; and requiring entry of specific data into

computer systems before processing orders.

Benefits of FMEA

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Improve the quality, reliability and safety of a product/process

Improve company image and competitiveness

Increase user satisfaction

Reduce system development timing and cost

Collect information to reduce future failures, capture engineering

knowledge

Reduce the potential for warranty concerns

Early identification and elimination of potential failure modes

Emphasize problem prevention

Minimize late changes and associated cost

Catalyst for teamwork and idea exchange between functions

Reduce the possibility of same kind of failure in future

Documents and tracks action taken to reduce risk

Integrates with Design for Manufacturing & Assembly techniques

Applications for FMEA

Process - analyze manufacturing and assembly processes.

Design - analyze products before they are released for production.

Concept - analyze systems or subsystems in the early design concept

stages.

Equipment - analyze machinery and equipment design before they are

purchased.

Service - analyze service industry processes before they are released

to impact the customer.

Types of FMEA

Process: analysis of manufacturing and assembly processes

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Design: analysis of products prior to production

Concept: analysis of systems or subsystems in the early design

concept stages

Equipment: analysis of machinery and equipment design before

purchase

Service: analysis of service industry processes before they are

released to impact the customer

System: analysis of the global system functions

Software: analysis of the software functions

Uses of FMEA

Development of system requirements that minimize the likelihood of

failures.

Development of methods to design and test systems to ensure that the

failures have been eliminated.

Evaluation of the requirements of the customer to ensure that those do

not give rise to potential failures.

Identification of certain design characteristics that contribute to

failures, and minimize or eliminate those effects.

Tracking and managing potential risks in the design. This helps avoid

the same failures in future projects.

Ensuring that any failure that could occur will not injure the customer

or seriously impact a system. To produce world class quality products