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UNCLASSIFIED / FOUO

   UNCLASSIFIED / FOUO




                           National Guard
                          Black Belt Training
                                Module 32

                         Failure Modes and Effects
                              Analysis (FMEA)


                                                     UNCLASSIFIED / FOUO

                                                         UNCLASSIFIED / FOUO
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CPI 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
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 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
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 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


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 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”….
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 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
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 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
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 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




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 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



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 FMEA


                                  SIPOC
                           Supplier-Input-Process-
                             Output-Customer




                                  C&E                        Process
                 FMEA
                                  Matrix                       Map




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 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)
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 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

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 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




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 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

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 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

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 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



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 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.

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Severity 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

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 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
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 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
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 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




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 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

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 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.

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 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


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 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


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 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
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 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
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 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
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
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
UNCLASSIFIED / FOUO




 Exercise: Prepare an FMEA
    Objective
           Create an FMEA for the GGA's 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
UNCLASSIFIED / FOUO




FMEA 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
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
UNCLASSIFIED / FOUO




         What other comments or questions
                   do you have?




                                   UNCLASSIFIED / FOUO

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NG BB 32 Failure Modes and Effects Analysis

  • 1. UNCLASSIFIED / FOUO UNCLASSIFIED / FOUO National Guard Black Belt Training Module 32 Failure Modes and Effects Analysis (FMEA) UNCLASSIFIED / FOUO UNCLASSIFIED / FOUO
  • 2. UNCLASSIFIED / FOUO CPI 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. 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. 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. 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. 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. 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. 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. 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. UNCLASSIFIED / FOUO FMEA SIPOC Supplier-Input-Process- Output-Customer C&E Process FMEA Matrix Map Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 10
  • 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. 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. 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. 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. 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. 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. 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. UNCLASSIFIED / FOUO Severity 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. UNCLASSIFIED / FOUO Exercise: Prepare an FMEA Objective Create an FMEA for the GGA's 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. UNCLASSIFIED / FOUO FMEA 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. 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. UNCLASSIFIED / FOUO What other comments or questions do you have? UNCLASSIFIED / FOUO