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  2. 2. FMEA is a procedure in product development and operationsmanagement for analysis of potential failure modes within asystem for classification by the severity and likelihood of thefailures. •Failure modes are any errors or defects in a process, design, or item, especially those that affect the customer, and can be potential or actual. •Effects analysis refers to studying the consequences of those failures.
  3. 3. Main terms to know:•FailureThe loss of an intended function of a device under statedconditions.•Failure modeThe manner by which a failure is observed; it generally describesthe way the failure occurs.•Failure effectImmediate consequences of a failure on operation, function orfunctionality, or status of some item
  4. 4. •Failure causeDefects in design, process, quality, or part application, whichare the underlying cause of the failure or which initiate aprocess which leads to failure.•SeverityThe consequences of a failure mode.It considers the worst potential consequence of a failure,determined by the degree of injury, property damage, or systemdamage that could ultimately occur.
  5. 5. HISTORY•Procedures for conducting FMECA were described in US ArmedForces Military Procedures document MIL-P-1629•By the early 1960s, contractors for the NASA were usingvariations of FMECA or FMEA under a variety of names.• The civil aviation industry was an early adopter of FMEA•During the 1970s, use of FMEA and related techniques spread toother industries.•In 1971 NASA prepared a report for the US GeologicalSurvey recommending the use of FMEA in assessment of offshorepetroleum exploration.
  6. 6. •FMEA moved into the Food industry in general.•In the late 1970s the Ford Motor introduced FMEA to theautomotive industry for safety and regulatory consideration.•FMEA methodology is now extensively used in a variety ofindustries including semiconductor processing, food service,plastics, software, and healthcare.
  7. 7. The process for conducting an FMEA is typicallydeveloped in three main phasesStep 1: SeverityStep 2: OccurrenceStep 3: Detection
  8. 8. THE PRE-WORKRobustness AnalysisA Description Of The System And Its FunctionA Block Diagram Of The SystemWorksheet
  9. 9. Step 1: Severity•Determine all failure modes based on the functionalrequirements and their effects.•Examples of failure modes are: Electrical short-circuiting,corrosion or deformation.•A failure mode in one component can lead to a failure mode inanother component, therefore should be listed in technical termsand for function. Hereafter the ultimate effect of each failuremode needs to be considered•A failure effect is defined as the result of a failure mode on thefunction of the system as perceived by the user.
  10. 10. •Examples of failure effects are: degraded performance, noiseor even injury to a user.•Each effect is given a severity number (S) from 1 (no danger)to 10 (critical). These numbers help an engineer to prioritize thefailure modes and their effects.•If the sensitivity of an effect has a number 9 or 10, actions areconsidered to change the design by eliminating the failuremode, if possible, or protecting the user from the effect.
  11. 11. Rating Meaning1 No effect Very minor (only noticed by2 discriminating customers) Minor (affects very little of the system,3 noticed by average customer)4/5/6 Moderate (most customers are annoyed) High (causes a loss of primary function;7/8 customers are dissatisfied) Very high and hazardous (product becomes inoperative; customers9/10 angered; the failure may result unsafe operation and possible injury)
  12. 12. Step 2: Occurrence•Looks at the cause of a failure mode and the number of times itoccurs.•All the potential causes for a failure mode should be identifiedand documented in technical terms.• A failure mode is given an occurrence ranking (O), again 1–10.This step is called the detailed development section of the FMEAprocess.•Occurrence also can be defined as %. If a non-safety issuehappened less than 1%, we can give 1 to it based on your productand customer specification.
  13. 13. Rating Meaning No known occurrences on1 similar products or processes2/3 Low (relatively few failures) Moderate (occasional4/5/6 failures)7/8 High (repeated failures) Very high (failure is almost9/10 inevitable)
  14. 14. Step 3: Detection•First, an engineer should look at the current controls of thesystem, that prevent failure modes from occurring or whichdetect the failure before it reaches the customer.•identify testing, analysis, monitoring and other techniques thatcan be or have been used on similar systems to detect failures.•Likeliness for a failure is identified or detected.
  15. 15. •Each combination from the previous 2 steps receivesa detection number (D). This ranks the ability of plannedtests and inspections to remove defects or detect failuremodes in time.•The assigned detection number measures the risk that thefailure will escape detection.•A high detection number indicates that the chances are highthat the failure will escape detection, or in other words, thatthe chances of detection are low.
  16. 16. Rating Meaning Certain - fault will be caught1 on test2 Almost Certain3 High4/5/6 Moderate7/8 Low Fault will be passed to9/10 customer undetected
  17. 17. Risk priority number (RPN)•RPN play an important part in the choice of an action againstfailure modes.•They are threshold values in the evaluation of these actions.•RPN can be easily calculated by multiplying the severity,occurrence and detectability RPN = S × O × D
  18. 18. •This has to be done for the entire process and/or design.•Once this is done it is easy to determine the areas ofgreatest concern.•The failure modes that have the highest RPN should begiven the highest priority for corrective action.•This means it is not always the failure modes with thehighest severity numbers that should be treated first. Therecould be less severe failures, but which occur more oftenand are less detectable.
  19. 19. •After these values are allocated, recommended actions withtargets, responsibility and dates of implementation are noted.•These actions can include specific inspection, testing or qualityprocedures, redesign (such as selection of new components),adding more redundancy and limiting environmental stresses oroperating range.•Once the actions have been implemented in the design/process,the new RPN should be checked, to confirm the improvements.•These tests are often put in graphs, for easy visualization.•Whenever a design or a process changes, an FMEA should beupdated.
  20. 20. The FMEA should be updated whenever •A new cycle begins (new product/process) •Changes are made to the operating conditions •A change is made in the design •New regulations are instituted •Customer feedback indicates a problem
  21. 21. Types of FMEA•Process: analysis of manufacturing and assembly processes•Design: analysis of products prior to production•Concept: analysis of systems or subsystems in the early designconcept stages•Equipment: analysis of machinery and equipment design beforepurchase•Service: analysis of service industry processes before they arereleased to impact the customer•System: analysis of the global system functions•Software: analysis of the software functions
  22. 22. Uses of FMEA•Development of system requirements that minimize thelikelihood of failures.•Development of methods to design and test systems to ensurethat the failures have been eliminated.•Evaluation of the requirements of the customer to ensure thatthose do not give rise to potential failures.•Identification of certain design characteristics that contributeto failures, and minimize or eliminate those effects.•Tracking and managing potential risks in the design. Thishelps avoid the same failures in future projects.
  23. 23. Advantages•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 engineeringknowledge•Reduce the potential for warranty concerns
  24. 24. •Early identification and elimination of potential failuremodes•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•Reduce impact of profit margin company•Reduce possible scrap in production
  25. 25. •Ensuring that any failure that could occur will not injurethe customer or seriously impact a system.•To produce world class quality products