FMEA- FA I L U R E M O D E & E F F E C T A N A LY S I S. PRESENTED BY: AJITH FRANCIS

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FMEA- FA I L U R E M O D E & E F F E C T A N A LY S I S. PRESENTED BY: AJITH FRANCIS 1

OBJECTIVES What is FMEA? Why is an FMEA important? History of FMEA Benefits of FMEA Limitations of FMEA How to conduct an FMEA? Examples. 2

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 FMEA provides a systematic method that allows you to organize and automate the process. 3

WHAT IS FMEA? 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. OPERATION FUNCTION FAILURE MODE EFFECT CAUSE CURRENT CONTROL 4

EXAMPLES Failure Mode : Moisture content inside the compressor. Effect : Compressor gets damaged. Cause : Installation of AC system went wrong Control : Follow the procedure. 5

Failure Mode : Too many spelling errors. EXAMPLES Effect :Customer dissatisfied, not understandable. Cause : Typing error. Control : Spell check. 6

EXAMPLES Failure Mode :Undersized cast product. Effect :Unfit for use. Cause :Shrinkage allowance not provided. Control :Awareness on the shrinkage on cooling or solidification. 7

Failure Mode :Frequent power failure. EXAMPLES Effect :Production delay. Cause :Generator malfunctioning. Control :Maintenance. 8

Failure Mode : No raw materials. EXAMPLES Effect : Delay in production. Cause :Re order point wasn t calculated. Control :Use of inventory control system. 9

EXAMPLES Failure Mode : Under inflated tyre-pressure below the required unit. Effect : Difficulty in controlling the vehicle. Cause : Unaware of pressure changes with climate variations Control : Pressure check based on the climate. 10

EXAMPLES Failure Mode :Candidate recruited to a wrong field. Effect :Inefficient work, less output from the candidate. Cause :Not aware of the candidate s qualification. Control :QFD 11

Failure Mode :Insufficient planning EXAMPLES Effect :Target not met. Cause :Forecasting error. Control :Improved forecasting technique 12

Failure Mode :Very high RPN/ Zero RPN EXAMPLES Effect :Confusion among the FMEA team. Cause :Ranking error. Control : Training and analysis. 13

KEY TERMS FAILURE MODE A failure mode is the root through which the failure has happened. This can also be mentioned as the deviation that has caused the effect. 14

KEY TERMS CAUSE -The causes are related to the mode and is the reason why the deviation (failure Mode) has happened and hence the effect. Probability of occurrence (O): A number from 1 to 10, depending on the likelihood of the failure mode s occurrence 1 = very unlikely to occur 10 = almost certain to occur 15

OCCURRENCE RANKING 1 Failure is unlikely Cpk > 2.00 16

KEY TERMS CURRENT CONTROL - The immediate tasks that prevent causes from occurring or which detect the failure before it reaches the customer Probability of detection (D): A number from 1 to 10, 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 detention 10 = impossible to detect 17

DETECTION RANKING 18

KEY TERMS EFFECT - The consequences of a failure mode. Severity considers the worst case outcome of a failure as determined by the degree of injury, property damage, or harm that could ultimately occur Severity (S): A number from 1 to 10, depending on the severity of the potential failure mode s effect 1 = no effect 10 = maximum severity 19

SEVERITY RANKING 20

RISK ASSESSMENT FACTORS 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. 21

RISK PRIORITY NUMBER 22

RISK PRIORITY NUMBER 23

FMEA ANALYSIS Process flow Control Plan Completed FMEA RPN Analysis 24

MY PROCESS Process-Purchasing an oil seal from store for Car servicing. Collecting details of the car. Providing requisition slip. Issuing of oil seal from store 25

PROCESS FLOW 26

FMEA 27

RPN ANALYSIS 28

COMPLETED FMEA 29

CONTROL PLAN 30

PROCEDURE FOR FMEA Operation :Patient Check Up Function /Require ment Failure mode Effect Severity (How bad is it?) Causes Occurren ce (How often?) Control method Detectio n RPN Diagnose the disease. 31

PROCEDURE FOR FMEA Operation :Patient Check Up Function /Require ment Failure mode Effect Severity (How bad is it?) Causes Occurren ce (How often?) Control method Detectio n RPN Diagnose the disease. High bacteria level. 32

PROCEDURE FOR FMEA Operation :Patient Check Up Function /Require ment Failure mode Effect Severity (How bad is it?) Causes Occurren ce (How often?) Control method Detectio n RPN Diagnose the disease. High bacteria level. Tempera ture (fever) 33

PROCEDURE FOR FMEA Operation :Patient Check Up Function /Require ment Failure mode Effect Severity (How bad is it?) Causes Occurren ce (How often?) Control method Detectio n RPN Diagnose the disease. High bacteria level. Tempera ture (fever) 10 34

PROCEDURE FOR FMEA Operation :Patient Check Up Function /Require ment Failure mode Effect Severity (How bad is it?) Causes Occurren ce (How often?) Control method Detectio n RPN Diagnose the disease. High bacteria level. Tempera ture (fever) 10 Outside food. 35

PROCEDURE FOR FMEA Operation :Patient Check Up Function /Require ment Failure mode Effect Severity (How bad is it?) Causes Occurren ce (How often?) Control method Detectio n RPN Diagnose the disease. High bacteria level. Tempera ture (fever) 10 Outside food. 7 36

PROCEDURE FOR FMEA Operation :Patient Check Up Function /Require ment Failure mode Effect Severity (How bad is it?) Causes Occurren ce (How often?) Control method Detectio n RPN Diagnose the disease. High bacteria level. Tempera ture (fever) 10 Outside food. 7 Cooking 37

PROCEDURE FOR FMEA Operation :Patient Check Up Function /Require ment Failure mode Effect Severity (How bad is it?) Causes Occurren ce (How often?) Control method Detectio n RPN Diagnose the disease. High bacteria level. Tempera ture (fever) 10 Outside food. 7 Cooking 5 38

PROCEDURE FOR FMEA Operation :Patient Check Up Function /Require ment Failure mode Effect Severity (How bad is it?) Causes Occurren ce (How often?) Control method Detectio n RPN Diagnose the disease. High bacteria level. Tempera ture (fever) 10 Outside food. 7 Cooking 5 10*7*5= 350 39

WHY IS AN FMEA IMPORTANT? Preventing problems is cheaper and easier than cleaning them up. Some things are too risky or costly to incur mistakes. Regulatory reasons 40

WHY IS AN FMEA IMPORTANT? Reduce the likelihood of customer complaints Reduce maintenance and warranty costs Reduce the possibility of safety failures 41

HISTORY OF FMEA Formally developed and applied by NASA in the 1960 s to improve and verify reliability of space program hardware during APOLLO missions. In 1974, the NAVY developed the MIL-STD-1629 regarding the use of FMEA. 42

FMEA TEAM Core Team 43

FMEA TEAM Core Team FMEA experts Six Sigma Professionals 44

FMEA TEAM Core Team FMEA experts Six Sigma Professionals Support Team 45

FMEA TEAM Core Team FMEA experts Six Sigma Professionals Support Team Representatives from: Production Development Design Sales Marketing Etc 46

FMEA TEAM Core Team FMEA experts Six Sigma Professionals Support Team Representatives from: Production Development Design Sales Marketing Etc 47

WHEN IS AN FMEA CARRIED OUT? When a process, product or service is being designed or redesigned, after quality function deployment. When improvement goals are planned for an existing process, product or service. When analyzing failures of an existing process, product or service. 48

FMEA IN DESIGN PROCESS If the high level design issues can be known and analyzed during the early stages, then the more detailed and in-depth analysis can be programmed and achieved before time constraints intervene. FMEA must, therefore, be initiated at as early a stage in the design process as possible, and at a time when there is something to analyze. It should then continue to run in parallel but slightly lagging the design effort. 49

HOW OFTEN SHOULD THE FMEA BE UPDATED? FMEA 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 50

REPORTING PROCEDURE IN FMEA The team of designers and the FMEA team should operate as parts of an overall team and not operate in an isolated manner. Criticism of a design by the FMEA analysts should not be accepted with bad grace by the designers. FMEA Team Client s Focal Point (Design/Operations)) Designers 51

FMEA PROCESS 52

STANDARDS IN FMEA It is important to specify the standard to which the FMEA is to be carried out. The use of a clearly defined methodology for carrying out the FMEA will allow the required in-depth study to be attained without the uncertainty and indiscipline that a less structured approach would bring. Increased confidence that all parties will accept the FMEA. 53

STANDARDS IN FMEA Standard that is usually referred to when carrying out an FMEA : US Department of Defense MIL-STD-1629A,(Used by the Government, Military and other organizations world wide.) 54

BENEFITS OF FMEA Greater customer satisfaction Reduce product development time Increased cooperation and teamwork between various functions 55

LIMITATIONS OF FMEA Employee training requirements. Initial impact on product and manufacturing schedules. Financial impact required to upgrade design, manufacturing, and process equipment and tools. 56

COMMON MISTAKES Could not separate Failure Mode, Cause & Effect. Ranking criteria too loose. Only identifying the problems but not the solutions. Do once, then keep in file. Lack of consistency. 57

58 T H A N K Y O U