FAILURE MODE AND EFFECT ANALYSIS (FMEA) THE BASICS OF FMEA

Presented By:

Joseph E. Kenol
NYCT, EMD QA, MOW, Dept. of Subways

REFERENCE: THE BASICS OF FMEA

Robin E. McDermott Raymond J. Mikulak Michael R. Beauregard

DEFINITION
FMEA is a systematic analysis of potential failure

modes aimed at preventing failures. It is intended to be a preventive action process carried out before implementing new or changes in products or processes
Ideally, FMEAs are conducted in the product

design or process development stages, although conducting it on existing products and processes may also yield benefits

PURPOSE
An effective FMEA identifies

corrective actions required to prevent failures from reaching the customer; and to assure the highest possible yield, quality, and reliability

THE HISTORY
The first formal FMEAs were conducted in the

aerospace industry in the mid-1960s, specifically looking at safety issues

Before long, FMEAs became a key tool for

improving safety, especially in the chemical process industries

While Engineers have always analyzed processes

and products for potential failures, the FMEA method standardizes the approach and establishes a common language that can be used both, within and between companies

HISTORY (CONT)
FMEA techniques have been around for 30 +

years
More widespread use thanks in large part to U.S.

automotive industry and its QS-9000 supplier requirements

QS-9000 standard requires suppliers to conduct

product/design and process FMEAs in an effort to eliminate potential failures

TYPES OF FMEA
System focuses on global system function Design focuses on components and

subsystems Process focuses on manufacturing and assembly processes Service focuses on service functions Software focuses on software functions

PRODUCT/DESIGN VS PROCESS FMEAs

Product/Design
The objective for a product or design FMEA is to uncover problems with products that will result in safety hazards, product malfunctions, or a shortened product life Product FMEAs can be conducted at different phases of a product life cycle (preliminary or final design, prototype) or on product that are already in production

PRODUCT/DESIGN VS PROCESS FMEAs

Process FMEA Uncovers problems related to the manufacture of the product Examples: A piece of automated assembly equipment may misfeed parts resulting in products not being assembled correctly In a chemical manufacturing process, temperature and mixing time could be sources of potential failures resulting in unusable product

BENEFITS
Substantially reduce costs by identifying design and

process improvements early in the development process when relatively easy and inexpensive changes can be made
Improves product/process quality and reliability More robust process, and reduces or eliminates the

trend for after-the-fact corrective action and late changes crises

Significantly reduce potential costly liability when

product or process do not perform as promised

Provide new ideas for improvements in similar designs

or processes

PART OF COMPREHENSIVE QUALITY SYSTEM

While FMEAs can be effective used alone,

maximum benefits cannot be achieved if systems are not in place to support it

Examples of comprehensive quality systems

include: Malcolm Baldrige, ISO 9001, QS9000 guidelines, Six Sigma management system, NY Empire State Advantage criteria

TWELVE KEY QMS ELEMENTS SUPPORTING FMEA PROCESS

Q uality System Elem ent Leadership R ole in the FM EA Process Supports FM E A pro cess, assuring the team has the necessary too ls, reso urces, and time to work o n the FM E A U ses the resu lts of FM E A s to assist in d irecting future impro vement activities Strategic Q uality P lanning Pro cess and business measures E ffective use of data and in formatio n Pro cess control (Both, co mpany and supp liers) H uman reso urces T raining

M easures and mo nito rs the results o f FM E As both, in terms o f pro duct quality and bo ttom line resu lts

Pro vides facts and dates to confirm FM E A analysis and to measure the resu lts of the FM E A pro cess

A ssures a stable process and product at the start o f an FM E A and statistically mo nito rs improvements made thro ugh the FM E A process Supports the FM E A team w ith appro priate training in quality improvement too ls and techniques Pro vides the basic sk ills necessary to work on an FM E A team, identify po tential problems, and determ ine so lutions Identifies FM E A as part o f the o verall quality strategy o f the co mpany. D efines w hen and w here FM E As sho uld be used and documents the FM E A pro cess the teams shou ld use A ssures the co nsistent o perating metho ds are bein g used thus reducing unnecessary variation in the pro duct o r pro cess A ssures co nsistency in the desig n pro cess Pro vides the team w ith info rmation abo ut w hats impo rtant to the custo mer, and informatio n that can be incorporated in the FM E A process Pro vides the FM E A team w ith additio nal data to co nsider during the FM E A pro cess

A docu mented quality p lan D ocumented pro cedures

D esign co ntro l Customer fo cus

A customer feed back system

OBJECTIVE
To look for all of the ways a process or

product can fail

Failures are not limited to problems with the product Because failures also can occur when the user makes a mistake, those types of failures should be included in the FMEA Anything that can be done to assure the product works correctly, regardless of how the user operates it, will move the product closer to 100% customer satisfaction

LOGIC OF FMEA
The FMEA process is a way to identify the

failures, effects, and risks within a process or product, and then, eliminate or reduce them
Each failure mode has a potential effect, and some

effects are more likely to occur than others

In addition, each potential effect has a relative risk

associated with it

10 STEPS FOR AN FMEA

Review the process Brainstorm potential failure modes List potential effects of each failure mode Assign a severity rating for each effect Assign an occurrence rating for each FM Assign detection rating for each FM and/or effects 7. Calculate the risk priority #(RPN) for each effect 8. Prioritize the FMs for action 9. Take action to eliminate or reduce the high-risk FMs 10. Calculate the Resulting RPN as the FMs are reduced or eliminated
1. 2. 3. 4. 5. 6.

ASSESSING THE RISK PRIORITY NUMBER [RPN]

Using data and knowledge of the process or

product, each potential failure mode and effect is rated in each of the three factors identified in the next slide
Rating the three factors is based on a

predetermined scale, low to high

The RPN is used to rank the need for corrective

actions to eliminate or reduce the potential failure modes

EVALUATING THE RISK OF FAILURES AND EFFECTS

The relative risk of a failure and its effects

is determined by three factors:

Severity- the consequence of the failure should it occur Occurrence- the probability or frequency of the failure occurring Detection- the probability of the failure being detected before the impact of the effect is realized

RISK PRIORITY NUMBER

The failure modes with the highest RPNs

should be attended first, although special attention should be given when the severity rating is high regardless of the RPN
Once corrective action has been taken, a

new RPN is determined by re-evaluating the severity, occurrence, and detection ratings

CALCULATE THE RISK PRIORITY NUMBER

The risk priority number (RPN) is simply calculated by multiplying the severity rating, times the occurrence probability rating, times the detection probability rating for all of the items Risk Priority Number = Severity X Occurrence X Detection

EXAMPLE OF A SEVERITY RATING SCALE

Rating 10 9 8 7 6 5 4 3 2 1 Description Dangerously High Extremely High Very High High M oderate Low Very Low Minor Very Minor None Definition Failure could injure the customer or an employee Failure would create noncom pliance with the federal government Failure would render the unit inoperable or unfit for use Failure causes a high degree of customer dissatisfaction Failure result in a subsystemor partial malfunction of the product Failure creates enough of a performance loss to cause the customer to com plain Failure can be overcom with modifications to the custom process or product, but there is minor e ers perform loss ance Failure would create a minor nuisance to the customer, but the customer can overcom it in the e process or product without performance loss Failure may not be readily apparent to the custom but would have minor effects on the er, custom process or product ers Failure would not be noticeable to the custom and would not affect the custom process or er ers product

EXAMPLE OF AN OCCURRENCE RATING SCALE

10 9 8 7 6 5 4 3 2 1 Description Very High-Failure is almost inevitable Definition More than one occurrence per day or a probability of more than three occurrences in 10 events (Cpk < 0.33) One occurrence every three days to four days or a probability of three occurrences in 10 events (Cpk apprx. 0.33) High-Repeated One occurrence per week or a probability of 5 occurrences in 100 events (Cpk apprx. Failure 0.67) One occurrence every month or one occurrence in 100 events (Cpk apprx. 0.83) ModerateOne occurrence every three months or three occurrences in 1000 events (Cpk apprx. Occasional Failure 1.00) One occurrence every six months to one year or one occurrence in 10,000 events (Cpk apprx. 1.17) One occurrence per year or six occurrences in 10,000 events (Cpk apprx. 1.33) Low-Relatively few One occurrence every one to three years or six occurrences in 10 million events (Cpk Failures apprx. 1.67) One occurrence every three to five years or 2 occurrences in 1 billion events (Cpk apprx. 2.00) Remote-Failure is One occurrence in greater than five years or less than two occurrences in 1 billion unlikely events (Cpk apprx. 2.00)

EXAMPLE OF A DETECTION RATING SCALE

Detection Rating Scale* *Should be m odified to fit the specific product or process Rating Description 10 Absolute Uncertainty ote 9 Very Rem 8 7 6 5 4 3 2 1 Rem ote Very Low Low M oderate M oderately High High Very High Alm Certain ost Definition The product is not inspected or the defect caused by failure is not detectable Product is sam inspected, and released based on A pled, cceptable Quality Level (A sam QL) pling plans Product is accepted based on no defectives in a sam ple Product is 100%m anually inspected in the process Product is 100%m anually inspected using go-no-go or other m istake-proofing gauges Som Statistical Process Control (SPC) is used in process, and product is final inspected off-line e SPCis used and there is im ediate reaction to out-of-control conditions m An effective SPCprogramis in place with process capability (CPk) greater than 1.33 All product is 100%autom atically inspected The defect is obvious or there is 100%autom inspection with regular calibration and preventive atic m aintenance of the inspection equipm ent

FMEA WORKSHEET
FAILURE MODE AND EFFECTS ANALYSIS (FMEA) Subsystem/Name: DC motor Model Year/Vehicle(s): 2000/DC motor Page 1 of 3 P = Probabilities (chance) of Occurrences Final Design: 31/5/2000 S = Seriousness of Failure to the Vehicle Prepared by: D = Likelihood that the Defect will Reach the customer R = Risk Priority Measure (P x S x D) Reviewed by: Chris FMEA Date (Org.): 27/4/2000 (Rev.) 31/5/2000) 3 = moderate or significant Mechanis m(s) & Causes(s) of Failure Wear and tear Effect(s) Of Failure Current Control 4 = high P.R.A. S D 5 = very high or catastrophic Recommended Action(s) Corrective Taken Action(s) Replace faulty wire. Q.C checked. Operator error Position controller breakdown in a longrun 4 4 3 48 Intensive training for operators.

1 = very low or none No. Part Name Part No. Function

2 = low or minor Failure Mode

Position Receive a Controller demand position

Loose cable connection Incorrect demand signal

Motor fails to move

FMEA WORKSHEET
FAILURE MODE AND EFFECTS ANALYSIS (FMEA) Subsystem/Name: DC motor Model Year/Vehicle(s): 2000/DC motor Page 2 of 3 P = Probabilities (chance) of Occurrences Final Design: 31/5/2000 S = Seriousness of Failure to the Vehicle Prepared by: D = Likelihood that the Defect will Reach the customer R = Risk Priority Measure (P x S x D) Reviewed by: Chris FMEA Date (Org.): 27/4/2000 (Rev.) 31/5/2000) 3 = moderate or significant Effect(s) Of Failure Extensive damage to the machine Current Control 4 = high P.R.A. S D 4 4 5 = very high or catastrophic Recommended Action(s) Corrective Taken Action(s) Indicator and Audile warning

1 = very low or none No. Part Name Part No. Drive Function

2 = low or minor Failure Mode Incorrect speed demand being received

Receive speed demand

Mechanism(s) & Causes(s) of Failure Fault in position controllers output

P 2

R 32

Measures Incorrect actual speed speed reading

Wear and tear Extensive damage

80

Voltmeter Improve check procedures

FMEA WORKSHEET
FAILURE MODE AND EFFECTS ANALYSIS (FMEA) Subsystem/Name: DC motor Model Year/Vehicle(s): 2000/DC motor Page 3 of 3 P = Probabilities (chance) of Occurrences Final Design: 31/5/2000 S = Seriousness of Failure to the Vehicle Prepared by: D = Likelihood that the Defect will Reach the customer R = Risk Priority Measure (P x S x D) Reviewed by: Chris FMEA Date (Org.): 27/4/2000 (Rev.) 31/5/2000) 4 = high P.R.A. S D 5 4 5 = very high or catastrophic Recommended Action(s) Corrective Taken R Action(s) 60 Durability test on leads

1 = very low or none 2 = low or minor 3 = moderate or significant No. Part Function Failure Mechanism(s) Effect(s) Current Name Mode & Causes(s) Of Failure Control Part No. of Failure 3 Motor Provides Signal loss Faulty leads Unstable voltage control signal loop Endanger operators Serious damage

P 3

PRIORITIZING FAILURE MODES FOR ACTION

The FMs can now be prioritized by ranking them

in order from the highest risk priority number to the smallest

A Pareto diagram is helpful to visualize the

differences between the various ratings

Usually, it helps to set a cut-off RPN, where any

FMs with an RPN above that establish point of unacceptable risk are attended to

PRIORITIZING THE FMs FOR ACTION

RESULTING RPN
The new RPN is called the Resulting RPN Improvement and corrective action must

continue until the resulting RPN is at an acceptable level for all potential failure modes

RISK ASSESSMENT COMPLETED WORKSHEET

TRAINING THE FMEA TEAM

While it is helpful for the FMEA team members to

have some understanding of the FMEA process, extensive training is not necessary if team members have previous problem solving team experience
A team leader who is well versed in the FMEA

process can easily guide the team through the process as they are actually performing the FMEA
This means that there is no need for extensive

classroom training and the team can immediately be productive, while at the same time, benefit from the most powerful form of training- Experience

WHAT DOES IT TAKE?

Although one person is responsible for coordinating

the FMEA process, all FMEAs are team-based

The purpose of an FMEA team is to bring a variety

of perspectives and experiences to the project

Because each FMEA is unique in dealing with

different aspects of the product or process, FMEA teams are formed when needed and disbanded once the FMEA is complete

FMEA TEAM
The best size for the team is usually four to six

people. The minimum number of people however, will be dictated by the number of areas affected by the FMEA
The customer of the process or product, whether

internal or external to the organization, can add another perspective as well and should be considered for team membership