NG BB 32 Failure Modes and Effects Analysis

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NG BB 32 Failure Modes and Effects Analysis

  1. 1. UNCLASSIFIED / FOUO UNCLASSIFIED / FOUO National Guard Black Belt Training Module 32 Failure Modes and Effects Analysis (FMEA) UNCLASSIFIED / FOUO UNCLASSIFIED / FOUO
  2. 2. UNCLASSIFIED / FOUOCPI Roadmap – Analyze 8-STEP PROCESS 6. See 1.Validate 2. Identify 3. Set 4. Determine 5. Develop 7. Confirm 8. Standardize Counter- the Performance Improvement Root Counter- Results Successful Measures Problem Gaps Targets Cause Measures & Process Processes Through Define Measure Analyze Improve Control ACTIVITIES TOOLS • Value Stream Analysis • Identify Potential Root Causes • Process Constraint ID • Reduce List of Potential Root • Takt Time Analysis Causes • Cause and Effect Analysis • Brainstorming • Confirm Root Cause to Output • 5 Whys Relationship • Affinity Diagram • Estimate Impact of Root Causes • Pareto on Key Outputs • Cause and Effect Matrix • FMEA • Prioritize Root Causes • Hypothesis Tests • Complete Analyze Tollgate • ANOVA • Chi Square • Simple and Multiple Regression Note: Activities and tools vary by project. Lists provided here are not necessarily all-inclusive. UNCLASSIFIED / FOUO
  3. 3. UNCLASSIFIED / FOUO Learning Objectives  Understand why we use Failure Modes and Effects Analysis (FMEA)  Summarize the different types of FMEAs  Learn how to link the FMEA to other LSS tools  Learn the steps necessary to work through an FMEA  Complete an exercise to create an FMEA Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 3
  4. 4. UNCLASSIFIED / FOUO Unintended Consequences For any new or redesigned process…  Your solution has to be aligned with your organization’s strategic and tactical goals in order to yield benefits that will be judged significant  You want to know about any unintended consequences or problems related to your solution before you implement or promote it  Awareness of potential difficulties will allow you to prevent or mitigate the effects of any failure  You want to minimize any “start up” problems and move to full implementation in the shortest possible time Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 4
  5. 5. UNCLASSIFIED / FOUO Risk Management Any significant issues identified in the FMEA must then be addressed by taking:  Preventive Action  Steps that reduce the likelihood of a problem occurring at all  Focused on reducing/eliminating root causes prior to occurrence  Contingent Action  Measures implemented to limit the damage caused by a potential problem should it occur  Focused on achieving the goal in spite of difficulties We can mistake proof our new or revised processes by proactively focusing on the “meaningful many”…. Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 5
  6. 6. UNCLASSIFIED / FOUO Example: Risk Management Use FMEA in Analyze to find potential causes of a problem Pizza Delivery Process and evaluate from a risk perspective  Task – Assign a van to each delivery driver  Potential Problem – Not enough drivers with vehicles to meet order demand (due to less flexibility in moving drivers to vehicles)  Preventive Action – Review volume patterns and match staff/vehicle schedules to ensure adequate coverage/capacity  Contingent Action – Identify “on-call” delivery staff and short-term vehicle rentals for expected or unexpected demand spikes (e.g., Super bowl)  Alarm – Delivery times >28 minutes and/or driver/vehicle shortages Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 6
  7. 7. UNCLASSIFIED / FOUO FMEA  Stands for Failure Modes and Effects Analysis.  FMEA is a structured approach to:  Identifying the areas and ways in which a process or system can fail (failure mode)  Identifying potential root causes and estimating the risk associated with theses causes  Identifying and prioritizing the actions that should be taken to reduce those risks  Evaluating and documenting proposed improvement plans or current control plans  FMEA is used to identify and reduce risk, and therefore unintended consequences, in the problem solving process Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 7
  8. 8. UNCLASSIFIED / FOUO When to Conduct an FMEA  When existing designs or processes are being changed  When new systems, products and processes are being designed.  When carry-over designs are used in new applications  After system, product or process functions are defined, but before beginning detailed final design  When the improvement idea has been decided Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 8
  9. 9. UNCLASSIFIED / FOUO Types of FMEAs  System  Analyzes systems and subsystems in early concept and design stages  Design  Analyzes new process, product or service design before rollout  Process  Used to improve existing transactional and operational processes Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 9
  10. 10. UNCLASSIFIED / FOUO FMEA SIPOC Supplier-Input-Process- Output-Customer C&E Process FMEA Matrix Map Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 10
  11. 11. UNCLASSIFIED / FOUO FMEA Procedure 1. For each process step (start with steps that give highest value from C&E Matrix) determine the ways in which the input to the step or the function of the step can go wrong (failure mode) 2. For each failure mode, determine effects  Select a severity rating for each effect (1-10 scale)  Any failure with a severity rating of 9 or 10 should be worked immediately 3. Identify potential causes of each failure mode  Select an occurrence rating for each cause (1-10 scale) 4. List current monitoring and controls for each cause  Select a detection rating for each cause (1-10 scale) Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 11
  12. 12. UNCLASSIFIED / FOUO FMEA Procedure (Cont.) 5. Calculate the Risk Priority Number (RPN) by multiplying the 3 ratings together (Max Score = 1000) 6. In the Improve phase, develop recommended actions, assign responsible persons, and note actions taken.  Prioritize so the highest RPNs are addressed first  Some level of risk may be accepted and no action is taken on RPNs below an established limit 7. Implement solutions from the first round of actions, create a re-prioritized FMEA and analyze for further necessary action Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 12
  13. 13. UNCLASSIFIED / FOUO FMEA Inputs and Outputs  Determine by utilizing the following CPI tools as needed: Inputs Outputs Brainstorming List of actions to C&E Matrix prevent causes or Process Map detect failure Process History modes Procedures FMEA Knowledge History of Experience actions taken Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 13
  14. 14. UNCLASSIFIED / FOUO Failure Modes and Effects  The relationship between failure modes and effects is not always 1 to 1. Failure Mode 1 Effect 1 Failure Mode 2 Effect 2 Failure Mode 1 Effect 1 Failure Mode 2 Effect 1 Failure Mode 1 Effect 2 Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 14
  15. 15. UNCLASSIFIED / FOUO Severity, Occurrence, and Detection  Severity  Importance of the effect on customer requirements  Often can’t do anything about this without fundamentally changing the system or design  Occurrence  Frequency with which a given cause occurs and creates failure modes (or probability it will occur)  Detection  The ability of the current monitoring and control method to detect before or after occurrence of a given cause Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 15
  16. 16. UNCLASSIFIED / FOUO Rating Scales and RPN  Rating formats can be quantitative or qualitative  The rating scales provided in this module were adopted from the Automotive Industry Action Group, AIAG – may need to be adjusted for transactional or service CPI projects  Typically:  1 = Not severe, not likely to occur or likely to detect  10 = Very severe, very likely to occur or not likely to detect  RPN is a product of the severity, occurrence and detection ratings: (Severity) x (Occurrence) x (Detection) = RPN (maximum of 1000) A customized rating scale may be created or the RPN level at which action is taken may be adjusted for your particular organization Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 16
  17. 17. UNCLASSIFIED / FOUO Severity Scale 1 of 2 Effect Criteria: Severity of Effect Defined Ranking Hazardous: May endanger operator or others. Failure mode affects safe Without product operation and / or involves noncompliance with 10 Warning government regulation. Failure will occur WITHOUT warning. Hazardous: May endanger operator or others. Failure mode affects safe With product operation and / or involves noncompliance with 9 Warning government regulation. Failure will occur WITH warning. Major disruption to production line. 100% of product may have to Very High be scrapped. Product inoperable, loss of primary function. 8 Customer very dissatisfied. Minor disruption to production line. Product may have to be sorted High and a portion (less than 100%) scrapped. Product operable, but at 7 a reduced level of performance. Customer dissatisfied. Minor disruption to production line. A portion (less than 100%) may have to be scrapped (no sorting). Product operable, but Moderate 6 some comfort / convenience item(s) inoperable. Customers experience discomfort. Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 17
  18. 18. UNCLASSIFIED / FOUOSeverity Scale 2 of 2 Effect Criteria: Severity of Effect Defined Ranking Minor disruption to production line. 100% of product may have to be reworked. Item operable, but some comfort / convenience Low 5 item(s) operable at reduced level of performance. Customer experiences some dissatisfaction. Minor disruption to production line. The product may have to be sorted and a portion (less than 100%) reworked. Fit / finish / Very Low 4 squeak / rattle item does not conform. Defect noticed by most customers. Minor disruption to production line. A portion (less than 100%) of the product may have to be reworked on-line but out-of-station. Fit Minor 3 / finish / squeak / rattle item does not conform. Defect noticed by average customers. Minor disruption to production line. A portion (less than 100%) of the product may have to be reworked on-line but in-station. Fit / Very Minor 2 finish / squeak / rattle item does not conform. Defect noticed by discriminating customers. None No effect. 1 Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 18
  19. 19. UNCLASSIFIED / FOUO Likelihood of Occurrence Scale Probability of Failure Possible Failure Rates Cpk Ranking Very High: > 1 in 2 < 0.33 10 Failure is almost inevitable 1 in 3 > 0.33 9 High: Generally associated with 1 in 8 > 0.51 8 processes similar to previous processes that have often failed 1 in 20 > 0.67 7 Moderate: Generally associated 1 in 80 > 0.83 6 with processes similar to previous processes which have 1 in 400 > 1.00 5 experienced occasional failures, 1 in 2,000 > 1.17 4 but not in major proportions Low: Isolated failures associated 1 in 15,000 > 1.33 3 with similar processes Very Low: Only isolated failures associated with almost identical 1 in 150,000 > 1.5 2 processes Remote: Failure is unlikely. No failures ever associated with < 1 in 1,500,000 > 1.67 1 almost identical processes Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 19
  20. 20. UNCLASSIFIED / FOUO Detection Scale Detection Criteria: Likelihood the existence of a defect Ranking will be detected by test content before product advances to next or subsequent process Almost Test content detects < 80 % of failures 10 Impossible Very Remote Test content must detect 80 % of failures 9 Remote Test content must detect 82.5 % of failures 8 Very Low Test content must detect 85 % of failures 7 Low Test content must detect 87.5 % of failures 6 Moderate Test content must detect 90 % of failures 5 Moderately High Test content must detect 92.5 % of failures 4 High Test content must detect 95 % of failures 3 Very High Test content must detect 97.5 % of failures 2 Almost Certain Test content must detect 99.5 % of failures 1 Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 20
  21. 21. UNCLASSIFIED / FOUO FMEA Example  We will conduct an FMEA on the All Ranks Club coffee example  A Black Belt wants to improve customer satisfaction with the coffee served at the All Ranks Club  Use the process map and completed C&E matrix follow Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 21
  22. 22. UNCLASSIFIED / FOUO All Ranks Club Coffee Process Map Primary Y = Taste Select process steps with biggest impact on taste Inputs Outputs Inputs Outputs Hot Water Cleaned Carafe Customer Complete Order Clean Carafe Receive Soap Dirty Water Order Coffee Order Scrubber Wet Scrubber Size Specification Clean Carafe Full Carafe Fill Carafe Complete Order Pour Coffee Filled Cup Cold Water w/Water Hot Coffee into Cup Measuring Mark Cup Full Carafe Filled Maker Customer Reply Pour Water into Filled Cup Offer Maker Empty Carafe Amount Specified Customer Cream & Cream Sugar Complete Order Filter Place Filter in Maker Maker w/Filter Sugar Amount Desired Maker w/Filter Maker w/Filter & Put Coffee in Fresh Coffee Coffee Complete Order Make Change Filter Complete Dosing Scoop Money Transaction Temperature Taste Maker w/Filter & Operating Maker Turn Maker On Strength Coffee Heat Brewed Coffee Coffee Delivery Smile Say Thank You Brewing Coffee Hot Coffee Happy Customer Select Temperature Setting Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 22
  23. 23. UNCLASSIFIED / FOUO Step 1. Determine Potential Failure Modes Process or Product Name: Prepared by: Page ___ of ___ Process/Product Responsible: FMEA Date (Orig) _____________ (Rev) ______________ FMEA Form Process Step/ Potential Potential S Potential O Current Controls D R Actions Resp. Actions S O D R Input Failure Effects E Causes C E P Recommended Taken E C E P Failure V C T N V C T N Mode E U E E U E What is the In what ways What is the impact R What causes R What are the existing C What are the What are the R R C process step does the Key on the Key Output I the Key Input R controls and T actions for completed actions I A T and input Input go Variables T to go wrong? E procedures I reducing the taken with the T N I under wrong? (Customer Y N (inspection and test) O occurrence of the recalculated RPN? Y C O investiga- Requirements)? C that prevent either the N cause, or E N tion? E cause or the Failure improving Mode? detection? Fill carafe Wrong with water amount of water Water too warm Carafe not A FMEA is a vertical process. Each step should clean be completed for the entire process before proceeding to the next step. Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 23
  24. 24. UNCLASSIFIED / FOUO Step 2. Identify Failure Effects and Severity Process or Product Name: Prepared by: Page ___ of ___ Process/Product Responsible: FMEA Date (Orig) _____________ (Rev) ______________ FMEA Form Process Step/ Potential Potential S Potential O Current Controls D R Actions Resp. Actions S O D R Input Failure Mode E Causes C E P Recommended Taken E C E P Failure V C T N V C T N Effects E U E E U E R What is the In what ways What is the impact I What causes R What are the existing C What are the What are the R R C process step does the Key on the Key Output T the Key Input R controls and T actions for completed actions I A T and input Input go Variables Y to go wrong? E procedures I reducing the taken with the T N I under wrong? (Customer N (inspection and test) O occurrence of the recalculated RPN? Y C O investiga- Requirements)? C that prevent either the N cause, or E N tion? E cause or the Failure improving Mode? detection? Fill carafe Wrong Coffee too with water amount of strong or too water weak Water too Coffee too warm strong Carafe not Foreign clean objects in coffee Bad taste Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 24
  25. 25. UNCLASSIFIED / FOUO Step 2. Identify Failure Effects and Severity Process or Product Name: Prepared by: Page ___ of ___ Process/Product Responsible: FMEA Date (Orig) _____________ (Rev) ______________ FMEA Form Process Step/ Potential Potential S Potential O Current Controls D R Actions Resp. Actions S O D R Input Failure Mode Causes C E P Recommended Taken E C E P Failure E C T N V C T N Effects V U E E U E What is the In what ways What is the impact E What causes R What are the existing C What are the What are the R R C process step does the Key on the Key Output R the Key Input E controls and T actions for completed actions I A T and input Input go Variables to go wrong? N procedures I reducing the taken with the T N I under wrong? (Customer I C (inspection and test) O occurrence of the recalculated RPN? Y C O investiga- Requirements)? T E that prevent either the N cause, or E N tion? Y cause or the Failure improving Mode? detection? Fill carafe Wrong Coffee too 5 with water amount of strong or too water weak Water too Coffee too 5 warm strong Carafe not Foreign 6 clean objects in coffee Bad taste 6 Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 25
  26. 26. UNCLASSIFIED / FOUO Step 3. Identify Potential Causes/Occurrence Process or Product Name: Prepared by: Page ___ of ___ Process/Product Responsible: FMEA Date (Orig) _____________ (Rev) ______________ FMEA Form Process Step/ Potential S Potential O Current Controls Potential D R Actions Resp. Actions S O D R Input Failure Mode Failure Effects E V Causes C C E P T N Recommended Taken E V C C E P T N What is the In what ways What is the impact E What causes U What are the E What are the What are the E U E process step does the Key on the Key Output R the Key Input R existing controls C actions for completed R R C and input Input go Variables I to go wrong? R and procedures T reducing the actions taken I A T under wrong? (Customer T E (inspection and test) I occurrence of with the T N I investiga- Requirements)? Y N that prevent either O Y C O the cause, or recalculated tion? C the cause or the N improving RPN? E N E Failure Mode? detection? Fill carafe with Wrong amount of Coffee too strong or 5 Faded level 4 water water too weak marks on carafe 5 Water spilled 5 from carafe Water too Coffee too strong 5 Faucet not 8 warm allowed to run and cool 5 Employee not 7 aware of new need for cool water Carafe not clean Foreign objects in 6 Carafe not 4 coffee washed Bad taste 6 Carafe stored 7 improperly Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 26
  27. 27. UNCLASSIFIED / FOUO Step 4. List Current Controls and Score Process or Product Name: Prepared by: Page ___ of ___ Process/Product Responsible: FMEA Date (Orig) _____________ (Rev) ______________ FMEA Form Process Step/ Potential PotentialS Potential O Current Controls D R Actions Resp. Actions S O D R Input Failure Mode Failure Effects E Causes C P Recommended Taken E C E P V C E N V C T N What is the In what ways What is the impact E What causes U What are the existing What are the What are the process step does the Key on the Key Output R the Key Input R controls and T actions for completed actions E U E and input Input go Variables I to go wrong? R procedures E reducing the taken with the R R C under wrong? (Customer T E (inspection and test) C occurrence of the recalculated RPN? I A T investiga- Requirements)? Y N that prevent either the cause, or T N I tion? T C cause or the Failure improving Y C O E Mode? I detection? E N O N Fill carafe with Wrong amount of Coffee too strong or 5 Faded level 4 Visual inspection 4 water water too weak marks on carafe 5 Water spilled 5 None 10 from carafe Water too Coffee too strong 5 Faucet not 8 Finger 4 warm allowed to run and cool 5 Employee not 7 None 10 aware of new need for cool water Carafe not clean Foreign objects in 6 Carafe not 4 Visual inspection 4 coffee washed Bad taste 6 Carafe stored 7 Visual Aid 5 improperly Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 27
  28. 28. UNCLASSIFIED / FOUO Step 5. Calculate RPNs Process or Product Name: Prepared by: Page ___ of ___ Process/Product Responsible: FMEA Date (Orig) _____________ (Rev) ______________ FMEA Form Process Step/ Potential PotentialS Potential O Current Controls D Actions Resp. Actions S O D R Input Failure Mode E Failure Effects Causes C E R Recommended Taken E C E P What is the V In what ways What is the impact E What causes C U What are the existing T E P What are the What are the V E C U T E N process step does the Key on the Key Output R the Key Input R controls and C N actions for completed actions R R C and input Input go Variables I to go wrong? R procedures T reducing the taken with the I A T under wrong? (Customer T E (inspection and test) I occurrence of the recalculated RPN? T N I Y N O Y C O investiga- Requirements)? that prevent either the cause, or C N E N In the Analyze tion? E cause or the Failure improving Mode? detection? Fill carafe with Wrong amount of water water Coffee too strong or too weak 5 Faded level marks on carafe 4 Visual inspection 4 80 phase, FMEA is 5 Water spilled 5 None 10 250 used to help from carafe Water too Coffee too strong 5 Faucet not 8 Finger 4 160 identify potential warm allowed to run and cool causes of process 5 Employee not aware of need 7 None 10 350 problems related to for cool water the Primary Y. Sort Carafe not clean Foreign objects in coffee 6 Carafe not washed 4 Visual inspection 4 96 by RPN to find most Bad taste 6 Carafe stored 7 Visual Aid 5 210 critical Xs for improperly further analysis. Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 28
  29. 29. UNCLASSIFIED / FOUO Step 6. Develop Recommended Actions Process or Product Name: Prepared by: Page ___ of ___ Process/Product Responsible: FMEA Date (Orig) _____________ (Rev) ______________ FMEA Form Process Step/ Potential Potential S Potential O Current Controls D R Actions Resp. Actions S O D R Input Failure Mode Failure Effects E Causes C E P E C E P V C T N Recommended Taken V C T N What is the In what ways What is the impact E What causes U What are the existing E What are the actions What are the E U E process step does the Key on the Key Output R the Key Input R controls and C for reducing the completed actions R R C and input Input go Variables I to go wrong? R procedures T occurrence of the taken with the I A T under wrong? (Customer T E (inspection and test) I cause, or improving recalculated RPN? T N I investiga- Requirements)? Y N that prevent either the O detection? Y C O tion? C cause or the Failure N E N E Mode? Fill carafe with Wrong amount of Coffee too strong or 5 Faded level 4 Visual inspection 4 80 water water too weak marks on carafe Complete this 5 Water spilled 5 None 10 250 Train employees Flo Employees trained from carafe Water too warm section Faucettonot 8 FMEA Coffee too strong 5 allowed the of run Finger 4 160 in 5the Improve None and cool Employee not 7 10 350 Train employees Mel Employees trained phase. aware of new need for cool water Carafe not clean Foreign objects in 6 Carafe not 4 Visual inspection 4 96 coffee washed Bad taste 6 Carafe stored 7 Training 5 210 Create storage bin & Alice New storage bin & improperly train employees employees trained Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 29
  30. 30. UNCLASSIFIED / FOUO Step 7. Compare RPN Before and After Process or Product Name: Prepared by: Page ___ of ___ Process/Product Responsible: FMEA Date (Orig) _____________ (Rev) ______________ FMEA Form Process Step/ Potential Potential S Potential O Current Controls D R Actions Resp. Actions S O D R Input Failure Mode Failure Effects E Causes C E P Recommended Taken V C T N E C E P What is the In what ways What is the impact E What causes U What are the existing What are the What are the process step does the Key on the Key Output R the Key Input R controls and E actions for completed actions V C T N C and input Input go Variables I to go wrong? R procedures T reducing the taken with the E U E under wrong? (Customer T E (inspection and test) I occurrence of the recalculated RPN? R R C investiga- Requirements)? Y N that prevent either the O cause, or tion? I A T C cause or the Failure N improving E Mode? detection? T N I Y C O E N Fill carafe with Wrong amount of Coffee too strong or 5 Faded level 4 Visual inspection 4 80 water water too weak marks on carafe 5 Water spilled 5 None 10 250 Train employees Flo Employees trained 5 2 7 70 from carafe Water too Coffee too strong 5 Faucet not 8 Finger 4 160 warm allowed to run and cool 5 Employee not 7 None 10 350 Train employees Mel Employees trained 5 1 8 40 aware of new need for cool water Carafe not clean Foreign objects in 6 Carafe not 4 Visual inspection 4 96 coffee washed Bad taste 6 Carafe stored 7 Training 5 210 Create storage bin & Alice New storage bin & 6 2 3 36 improperly train employees employees trained Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 30
  31. 31. UNCLASSIFIED / FOUO Exercise: Prepare an FMEA Objective Create an FMEA for the GGAs Budget Department Instructions  Select one process step critical to improving the Primary Y  Complete the FMEA through the first RPN calculation  Sort by RPN to determine critical Xs for further analysis  Be prepared to report results to the group Time = 20 Minutes UNCLASSIFIED / FOUO 31
  32. 32. UNCLASSIFIED / FOUOFMEA Template Process/Product Failure Modes and Effects Analysis Form (FMEA) Pag Process or Prepared by: e Product Name: ____ Responsible: FMEA Date (Orig) ______________ (Rev) _____________ O Process Potential Failure Potential Failure D S Potential Causes C Current Controls Step / Input Mode Effects E E C T What is the In what ways does What is the impact V What causes the Key U What are the existing E process the Key Input go on the Key Output E Input to go wrong? R controls and procedures RP C step and wrong? Variables (Customer R R (inspection and test) that N T Input under Requirements)? I E prevent either the cause I investiga- T N or the Failure Mode? O tion? Y C N E 0 0 0 Required Deliverable 0 0 0 0 0 0 UNCLASSIFIED / FOUO 0
  33. 33. UNCLASSIFIED / FOUO Takeaways  Use FMEA in the Analyze phase to determine potential and significant Xs impacting Y from a risk perspective  Include significant Xs identified here in the improvement plan  Show impact of improvements using before and after RPN calculations Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 33
  34. 34. UNCLASSIFIED / FOUO What other comments or questions do you have? UNCLASSIFIED / FOUO

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