Fmea Final

FMEA

What is FMEA?

A systemized group of activities designed to:▪ recognize and evaluate the potential failure of a product/process and its effects▪ identify actions which could eliminate or reduce the chance of potential failure▪ document the process

Failure Mode and Effect Analysis

Failure Mode and Effect Analysis

Simply put FMEA is:a process that identifies all the possible types of failures that could happen to a product and potential consequences of those failures.

FMEA TermsFailure mode - the way in which

something might fail

Effects analysis – studying the consequences of the various failure modes to determine their severity to the customer.

Why do an FMEA?Preventing problems is cheaper

and easier than cleaning them up.Some things are too risky or costly

to incur mistakes.

The Reasons for FMEA Get it right the first time Indentifies any inadequacies in the

development of the product Tests and trials may be limited to a few

products Regulatory reasons Continuous improvement Preventive approach Team building Required procedures

FMEA Provides the Potential to:

Reduce the likelihood of customer complaints

Reduce the likelihood of campaign changesReduce maintenance and warranty costsReduce the possibility of safety failuresReduce the possibility of extended life or

reliability failuresReduce the likelihood of product liability

claims

Benefits Identify potential and known failuresReduce the number of engineering

changesReduce product development timeLower start-up costsGreater customer satisfaction Increased cooperation and

teamwork between various functionsContinuous improvement

History An offshoot of Military Procedure MIL-P-1629, titled

Procedures for Performing a Failure Mode, Effects and Criticality Analysis, dated November 9, 1949.

Used as a reliability evaluation technique to determine the effect of system and equipment failures.

Failures were classified according to their impact on mission success and personnel/equipment safety.

Formally developed and applied by NASA in the 1960’s to improve and verify reliability of space program hardware.

Concept FMEA Used to analyze concepts in the early

stages before hardware is defined (most often at system and subsystem)

Focuses on potential failure modes associated with the proposed functions of a concept proposal

Includes the interaction of multiple systems and interaction between the elements of a system at the concept stages.

Design FMEAAid in the objective evaluation of design

requirements and design alternativesAid in the initial design for

manufacturing and assembly Increase the probability that potential

failure modes have been consideredProvide additional information to aid in

the planning of efficient design testing

Process FMEA Indentify potential product related process

failure modes Assess the potential customer effects of the

failures Indentify the potential manufacturing

causes on which to focus on Develop a ranked list of potential failure

modes Document the results of the manufacturing

Types of FMEA

Resources NeededCommitment of top managementKnowledgeable individuals Individuals attentive to FMEA

timelinesPeople resources may be internal

or external to the business or a combination of both

FMEA TimingFMEA should be updated:

▪at the conceptual stage▪when changes are made to the design▪when new regulations are instituted▪when customer feedback indicates a problem

AdvantagesEnhance design and

manufacturing efficienciesAlleviate late change crisesMinimize exposure to product

failuresAugment business records Improve “bottom line” resultsAdd to customer satisfaction

LimitationsEmployee training requirements Initial impact on product and

manufacturing schedulesFinancial impact required to

upgrade design, manufacturing, and process equipment and tools

▪These limitations should be recognized and treated as short term and minimal interruptions to a business.

Risk Assessment FactorsSeverity (S): A number from 1 to 5, depending

on the severity of the potential failure mode’s effect 1 = no effect5 = maximum severity

Probability of occurrence (O): A number from 1 to 5, depending on the likelihood of the failure mode’s occurrence1 = very unlikely to occur5 = almost certain to occur

Risk Assessment FactorsProbability of detection (D): A number from 1 to 5,

depending on how unlikely it is that the fault will be detected by the system responsible (design control process, quality testing, etc.)1 = nearly certain detention5 = impossible to detect

Risk Priority Number (RPN): The failure mode’s risk is found by the formula RPN = S x O x D. RPN = Severity x Probability of Occurrence x Probability of Detection. RPN will be a number between 1 (virtually no risk) and 125 (extreme risk).

Risk Priority Number

Procedures for FMEA

Necessity

“Process

Function”

Problem

“Failure Mode”

Effects How bad is it?

“Severity”

Causes How Likely?

“Occurrence”

Score Steps to

Prevent

Procedures for FMEA

Necessity

“Process

Function”

Problem

“Failure Mode”

Effects How bad is it?

“Severity”

Causes How Likely?

“Occurrence”

Score Steps to

Prevent

Put PB on bread

Procedures for FMEA

Necessity

“Process

Function”

Problem

“Failure Mode”

Effects How bad is it?

“Severity”

Causes How Likely?

“Occurrence”

Score Steps to

Prevent

Put PB on bread

No PB

Procedures for FMEA

Necessity

“Process

Function”

Problem

“Failure Mode”

Effects How bad is it?

“Severity”

Causes How Likely?

“Occurrence”

Score Steps to

Prevent

Put PB on bread

No PB Jelly Sandwich

Procedures for FMEA

Necessity

“Process

Function”

Problem

“Failure Mode”

Effects How bad is it?

“Severity”

Causes How Likely?

“Occurrence”

Score Steps to

Prevent

Put PB on bread

No PB Jelly Sandwich

5/5

Procedures for FMEA

Necessity

“Process

Function”

Problem

“Failure Mode”

Effects How bad is it?

“Severity”

Causes How Likely?

“Occurrence”

Score Steps to

Prevent

Put PB on bread

No PB Jelly Sandwich

5/5 Out of Stock

Past Expiration

Procedures for FMEA

Necessity

“Process

Function”

Problem

“Failure Mode”

Effects How bad is it?

“Severity”

Causes How Likely?

“Occurrence”

Score Steps to

Prevent

Put PB on bread

No PB Jelly Sandwich

5/5 Out of Stock

Past Expiration

2/5

Procedures for FMEA

Necessity

“Process

Function”

Problem

“Failure Mode”

Effects How bad is it?

“Severity”

Causes How Likely?

“Occurrence”

Score Steps to

Prevent

Put PB on bread

No PB Jelly Sandwich

5/5 Out of Stock

Past Expiration

2/5 10

Procedures for FMEA

Necessity

“Process

Function”

Problem

“Failure Mode”

Effects How bad is it?

“Severity”

Causes How Likely?

“Occurrence”

Score Steps to

Prevent

Put PB on bread

No PB Jelly Sandwich

5/5 Out of Stock

Past Expiration

2/5 10 Check Pantry

Check Expiration Date

Conduct an FMEAConduct a process FMEA on a

paper airplaneBuild a paper airplaneConduct a design FMEA on your

paper airplanePaper Airplane Competition