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Failure Mode Effect Analysis (FMEA)

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Failure Mode Effects Analysis




                    Black Belt Training -- Week 1
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Objective:

       The Breakthrough Strategy
       Warm-up exercise
       Description & definitions
       FMEA basics
       The form
       The method
       Step-by-step example
       Next steps
       Exercise
       Approaches to FMEAs



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The Breakthrough Strategy

 Step I: Process Measurement


     Plan project and identify key
                                      Step III: Process Improvement
   process input / output variables

   Perform gage studies essential
       measurement systems               Verify critical inputs using DOE

    Perform short-term capability       Determine the optimum operating
  studies and evaluate control plan                 window

                                            Update the control plan
  Step II: Process Analysis
                                      Step IV: Process Control
    Complete FMEA and evaluate
           control plan
                                        Finalize the process control plan
   Complete Multi-vari studies and
    identify potential key inputs          Ongoing verification of the
                                          stability and capability of the
            Review data and
                                                      process
     prioritize key input variables



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Measurement Phase
    Project Definition:
     » Problem Description (Authorize.ppt)
     » Project Metrics (Metrics.xls)
    Process Exploration:
     » Process Flow Diagram
     » C&E Matrix, PFMEA, Fishbones
     » Data collection system
    Measurement System(s) Analysis (MSA):
     » Attribute / Variable Gage Studies
    Capability Assessment (on each Y)
     » Capability (Cpk, Ppk, σ Level, DPU, RTY)
    Graphical & Statistical Tools
    Project Summary
     » Conclusion(s)
     » Issues and barriers
     » Next steps
    Completed “Local Project Review”
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                              Breakthrough Strategy
                                                                                                               Process Map
                                                                                                                                                                                                                                                                     Cause and
                                                                                                                                                                                                                                                                    Effects Matrix
                        PAPERWORK                                              TURN STEAM ON
                                                                                                                                  LOAD DMF           LOAD DICY       LOAD 2MI        1
                                                                               TO DICY TANK
                                                                                                                                                                                                                                                                                                              1           2            3             4         5        6            7           8       9      10              11




                                                                                                                                                                                                                                                                                                              OUTPUTS




                                                                                                                                                                                                                                                                                                                                                                   Low Capacity




                                                                                                                                                                                                                                                                                                                                                                                                                            Poor Reactor
                                                                                                                                                                                                                                                                                                                                                                                                                            Performance
                                                                                                                                                                                                                                                                                                                                                                                                             Corrosion of
                           BILL OF MATERIALS                                      SCALE ACCURACY




                                                                                                                                                                                                                                                                                                                                   Moisture in




                                                                                                                                                                                                                                                                                                                                                                                                             Equipment
                                                                                                                                                                                                                                                            INPUTS

                                                                                                                                                                                                                                                                                                          Heavies in




                                                                                                                                                                                                                                                                                                                                                                                  Excessive
                                                                                                                                                                                                                                                                                                                                                                                  Downtime
                                                                                                                                                                                                                                                                                                                                                                   From Unit
                                                                                                                             LOAD ACCURACY           LOAD ACCURACY




                                                                                                                                                                                                                                                                                                                                                 Acidity in
                                                                                                                                                                                                                                                                                                                       Lights in




                                                                                                                                                                                                                                                                                                                                                                                              Material
                                                                                                                                                                                                                                                                                                          Product

                                                                                                                                                                                                                                                                                                                       Product

                                                                                                                                                                                                                                                                                                                                   Product

                                                                                                                                                                                                                                                                                                                                                 Product




                                                                                                                                                                                                                                                                                                                                                                                              Losses
                                                                                                                                                                     LOAD ACCURACY
                                                                                                                                                                                                                                                                 Process Step         Process Inputs                                                                                                                                       Total
                           ISO PROCEDURES                                         PREHEATING
                                                                                                                             CLEANLINESS             ENVIRONMENT
                                                                                                                                                                     ENVIRONMENT                                                                           139       Day Tanks        Analysis               10           10           9             9                                                                                      335
                                                                                                                                                       (HUMIDITY)
                           REWORK                                                                                                                                      (HUMIDITY)                                                                            9        Reactor         Cat./HF Ratio                                                                     5                                         8              7          157
                                                                                                                             RAW MATERIAL            RAW MATERIAL                                                                                            7        Reactor         Rxr Temperature                                                                   6                        5                4              7          149
                                                                                                                                                                     RAW MATERIAL                                                                           73    Lights Removal      Condenser Leak                                   4                                             8           2                4              1          148
                                                                                                                                                                                                                                                            74    Lights Removal      Reboiler Leak                                    4                                             8           2                4              1          148
                                                                                                                                                     MIXER SPEED                                                                                           131      Purification      Low Stages              8                                                                      8                                                      144
                                                                                                                                                                     MIXER SPEED                                                                           144     Final Storage      Containers              3           2            6             6                                                                                      140
                                                                                                                                                                                                                                                           100     Neutralization     pH Value                            6                          6                                                            3                         138
                                                                                                                                                                                                                                                            16    Catalyst Stripper   Pluggage                                                                          3            6                            5              3          137
                                                                                                                                                                                                                                                           111         Drying         Decomposition           2           6                          3                                           2                2                         134
                                                                                                                                                                                                                                                            39          Drier         Water Carryover                                  4                                             6                            5              1          132
                                                                                                                                                                                                                                                            34          Drier         Molecular Sieve                                  3             3                  2            7           2                                          125




                                                             FMEA
                                                                                                                                                                                Initial Assessment of Capabilities
 P rocess
  tep/P
 S art      Potential FailureMode Potential FailureEffects
                                                             S
                                                             E       Potential Causes
                                                                                        O
                                                                                        C        Current Controls
                                                                                                                    D
                                                                                                                    E RN
                                                                                                                       P
                                                                                                                             R
                                                                                                                                Actions
                                                                                                                                   m
                                                                                                                              ecom ended
                                                                                                                                             Resp.
                                                                                                                                                                                         and Control Plans
   um
 N ber                                                       V                          C                           T




 O TIN
C A G&       IR   O M SK
            D TYPH TO A            IC O R C IN ,
                                  M RCAK G                       LO F EQ E C O C AN G
                                                                   W R U N Y F LE IN         O , ISU S TIO
                                                                                            S P V ALIN PEC N                  C EA   EQ E C
                                                                                                                            IN R SEFR U N Y MG
  A IN
IM G G                            D    IN TIO , EA
                                   ELAM A N STR KS           8                          8                           7   448 TOO C EVE Y20
                                                                                                                                NE R
                                                                                                                            P ELS
                                                                                                                             AN                                                                                                     Process
                                                                                                                                                                                                                                                         Cpk               Measurement          %R&R       Sample               Sample                        Control
                                                                                                                             P O LE IN
                                                                                                                           IM R VEC AN G     PF                                          Process Step       Input     Output      Specification                                                                                                                                   Reaction Plan
                                                                                                                                                                                                                                                     Mean - Sigma           Technique            P/T        Size               Frequency                      Method
                                                                                                                           M O
                                                                                                                            ETH D                                                                                              (Target, LSL, USL)
                                                                                                                                                                                         Coating        Dosage                 22.5, 22, 23         1.22               UIL-1700                25%                             1/hr                      Auto-timer Cross check
                                                                                                                            U C AS FF-LIN
                                                                                                                           P R H EO      E   MG                                                                     Coating    24,23,25             1.54               Micrometer              31%/0.47 35 pts per             1/hr                      Coating & Adjust previous
                                                                                                                            LE IN STEM
                                                                                                                           C AN GSY                                                                                 Height                                                                              panel                                            pump
                                                                                                                                                                                                                                                                                                                                                         speed
                                                                                                                              T N E ASK
                                                                                                                           TES O -LIN M      PF                                                                     Coating    14,12,16             1.78               Laser Measuring                                         1/hr                                 None in place
                                                                                                                            EP C EN
                                                                                                                           R LA EM T                                                                                width                                              Device
                                                                                                                                                                                                                    Coating    36,34,38             1.43               Laser Measuring                                         1/hr                                               None in place
                                                                                                                                                                                                                    length                                             Device
                                                                                                                                                                                                        Vacuum                 35" Hg                                  Vacuum Gauge                                            1/hr                      Monitor                  Compare
                                                                                                                                                                                                                                                                                                                                                                                  guages, look
                                                                                                                                                                                                                                                                                                                                                                                  for blockage




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Warm-Up Exercise

  The Question:
   » What would you want to know about a defect?
  Take 60 seconds.
   » Jot down your answer(s) on scrap paper.
  On a flipchart lets document your thoughts.
  The Answer:
   » All of these are documented in a document called the:



   Failure Modes & Effects Analysis



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Where Does Risk Come From?
                        Potential
                                                          Poor control
                         Safety
Unclear Customer                                         plans & SOP’ s
                        Hazards
  Expectations                                                             Poor Process
                                                                            Capability


                      Cumulative Risk
                                                                     Raw Material
   Vague                                                              Variation
Workmanship
 Standards
                                                          Poorly developed
        Machine                                             Specification
        Reliability         Measurement
                                                               Limits
                              Variation
                           (Online and QC)

                                    D. H. Stamatis, FMEA:FMEA from Theory to Practice, Quality Press, 1995


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History

                            s
     First used in the 1960’ in the Aerospace
     industry during the Apollo missions
     In 1974 the Navy developed MIL-STD-1629
     regarding the use of FMEA
                              s,
     In the early to mid 1970’ automotive
     applications driven by liability costs




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Definition - FMEA

   A structured approach to:
   »   identifying the ways in which a product or process can fail
   »   estimating the risk associated with specific causes
   »   prioritizing the actions that should be taken to reduce the risk
   »   evaluating the design validation plan (Product) or the current
       control plan (Process)
   Primary Directive: Identify ways the product or process can
   fail and eliminate or reduce the risk of failure
   In short… a process FMEA will:
   » ultimately capture the entire process
   » identify ways the product or process failed because of these X's
   » and facilitates the documentation of a plan to prevent those
     failures




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Role of Process FMEA

  Key tool for the process team to improve the process in a
  preemptive manner (before failures occur)
  Used to prioritize resources to insure process
  improvement efforts are beneficial to customer
  Used to document completion of projects
  Should be a dynamic document, continually reviewed,
  amended, updated
  Used to analyzes new manufacturing processes
  Used to identifies deficiencies in the Process Control Plan
  Can establish and prioritize actions
  Evaluates the risk of process changes
  Identifies potential variables to consider in Multi-vari and
  DOE studies
  Guides the development of new manufacturing processes
  Helps set the stage for breakthrough

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Type of FMEA’s
  System
   » used to analyze systems and sub-systems in the early concept
     and design stages. Focuses on potential failure modes
     associated with the functions of a system caused by the design.
  Design
   » used to analyze product designs before they are released to
     production. A DFMEA should always be completed well in
     advance of a prototype build. Focuses on product function.
  Process
   » used to analyze manufacturing, assembly, or any other
     processes. Focuses on process inputs.
  Project:
   » documents and addresses failures that could happen during a
     major program.
  Software:
   » documents and addresses failure modes associated with
     software functions.

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FMEA Inputs and Outputs

   Inputs
    » Process map
    » C&E matrix
    » Process history
    » Process technical procedures
   Outputs
    » List of actions to prevent causes or to detect
      failure modes
    » History of actions taken and future activity




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FMEA Team

  Team approach is necessary
  Responsible Black Belt typically leads the team
  Document should be owned by the process owner
  Recommended representatives:
  » Design
  » Manufacturing operators / supervisors
  »   Quality
  »   Reliability
  »   Materials
  »   Testing
  »   Supplier



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Terminology
  Failure Mode :
   » a description of a “non-conformance” at a particular process step (also
      know as a shop floor defect).
  Failure Effect :
   » the effect a particular failure mode will have on the customer (attempt to
      quantified with respect to Y's).
  Severity (of failure effect, scale of 1 to 10) :
   » an assessment of the seriousness of the failure effect on the customer. The
      customer can be the end customer and / or the next process operation.
  Failure Cause :
   » something which can be corrected or controlled (X) that describes “how the
      failure mode could have occurred”.
  Occurrence (of failure cause, scale of 1 - 10) :
   » an assessment of the frequency with which the failure cause occurs. “How
      often does this X fail in a specific way”?
  Detection (of failure cause or failure mode, scale of 1 - 10) :
   » an assessment of the likelihood (or probability) that your current controls
      will detect 1) when the X fails or 2) when the failure mode occurs.
  Risk Priority Number :
   » = Severity X Occurrence X Detection.
   » used to prioritize recommended actions. Special consideration should be
      given to high Severity ratings even if Occurrence and Detection are low.

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Definition of Terms - Failure Mode

   Failure Mode
    » the way in which a specific process input fails - if not detected
      and either corrected or removed, will cause Effect to occur.
   Can be associated with a defect (in discrete manufacturing) or
   a process input variable that goes outside of specification.
                                             s
    » Anything that an operator can see that’ wrong is considered a
      Failure Mode.
   Continuous Process Examples
    » Temperature Too High
    » Heat transfer too fast
    » Agitator too slow
   Discrete
    » Pits
    » Internal Contamination



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Definition of Terms - Effect

   Effect
    » impact on customer requirements. Generally external
      customer focus, but can also include downstream
      processes.
   Continuous Process Failure Mode/Effect Examples:
    » Temperature too high: Melt Viscosity Variable
    » Heat transfer too fast: Conversion rate too low
    » Agitator too slow: Extractables too high
   Discrete Process Failure Mode/Effect
    » Pits: Internal opens on printed circuit
    » Internal Contamination: Short between layers in a multi-
      layer printed circuit board



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Definition of Terms - Cause

   Cause
    » Sources of process variation that causes the Failure Mode
      to occur. Identification of Causes should start with Failure
      Modes associated with the highest severity ratings.
   Continuous Process Failure Mode/Cause Examples:
    » Temperature Too High: Thermocouple out of calibration
    » Heat transfer too fast: Dowtherm temp too high
    » Agitator too slow: Faulty inverter
   Discrete Process Failure Mode/Cause Examples
    » Pits: High particle count in clean room
    » Internal Contamination: Flaking paint




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Definition of Terms - Current Controls

   Current Controls
    » systematized methods/devices in place to prevent or detect failure modes
      or Causes (before causing effects).
    » Prevention consists of fool proofing, automated control and set-up
      verifications
    » Controls consists of audits, checklists, Inspection, laboratory testing,
                    s,
      training, SOP’ preventive maintenance, etc.
   Which is more important to process improvement, prevention or
   detection?
   Continuous Process Cause/Current Controls Examples
    » Thermocouple out of calibration: Calibration schedule
    » Dowtherm temp too high: Computer Control of primary Dowtherm supply
    » Faulty inverter: Inverter infra-red inspection schedule and sign-off
   Discrete Process Cause/Current Controls
    » High particle count in clean room: Spc on particle count
    » Flaking paint: Evaluation of paint samples to determine source of flakes.



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          Overview
                                                                   S                       O                         D    R
  Process                                                                                                                        Actions
              Potential Failure Mode   Potential Failure Effects   E    Potential Causes   C      Current Controls   E    P
 Step/Input                                                                                                                   Recommended
                                                                   V                       C                         T    N



                                        What is                      How
                                                                                                 How can             How
                                                                   0 Bad?
                                       the Effect                                          0
                                                                                                  this be
                                                                                                                     0 0

What             What                                                                                                well?
                                         on the                                                  found?
is the          can go                 Outputs?
                                                                   0                       0                         0    0


Input           wrong                                              0
                                                                       What are            0                         0    0
                                                                                                                              What can
                with the                                           0     the               0
                                                                                                How                  0    0   be done?
                Input?                                                 Causes?                 Often?
                                                                   0                       0                         0    0




                                            FN: FMEA_CP.xls


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Exercise

 Pick an input from your project and complete this chart.


 Input     Failure Mode   Effects        Cause            Controls




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FMEA Model

         Cause
         Cause




                          Failure Mode
                           Failure Mode
                            (Defect)
                              (Defect)
    Material or process
           input                                     Effect
                                                      Effect




                          Process Step



                                                External customer
       Controls
       Controls                                  or downstream
                                                  process step

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  FMEA Model
Prevention                                                Which is best case?
             Cause
                           Detection                      Which is worst case?
             Cause



                                                   Detection
                                   Failure Mode
                                    Failure Mode
                                     (Defect)                                 Detection
                                       (Defect)
     Material or process
            input                                              Effect
                                                                Effect




                                  Process Step


                                                          External customer
                                                           or downstream
                Controls
                Controls                                    process step
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Linking Failure Modes to Effects

      Failure Mode 1                           Effect 1
      Failure Mode 2                           Effect 2



                                                                    Effect 1
                              Failure Mode 1
                                                                    Effect 2




             Failure Mode 1
                                                      Effect 1
             Failure Mode 2




 Note that the relationship between the Failure Mode and the Effect is not
                                always 1-to-1
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Risk Priority Number (RPN)

   The output of an FMEA is the “Risk Priority Number”
   The RPN is a calculated number based on information you
   provide regarding
    » the potential failure modes,
    » the effects, and
    » the current ability of the process to detect the failures before
      reaching the customer
   It is calculated as the product of three quantitative ratings,
   each one related to the effects, causes, and controls:
      RPN = Severity X Occurrence X Detection
             Effects
             Effects        Causes
                            Causes         Controls
                                           Controls




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Risk Priority Number
  Risk Priority Number is not sacred
  Scaling for Severity, Occurrence and Detection can be locally
  developed.
  Other categories can be added. For example, one Black Belt added
  an Impact score to the RPN calculation to estimate the overall impact
  of the Failure Mode on the process.
  Severity (of Effect)
   » importance of effect on customer requirements - could also be concerned
     with safety and other risks if failure occurs (1=Not Severe, 10=Very
     Severe)
  Occurrence (of Cause)
   » frequency with which a given Cause occurs and creates Failure Mode.
     Can sometimes refer to the frequency of a Failure Mode (1=Not Likely,
     10=Very Likely)
  Detection (capability of Current Controls)
   »   ability of current control scheme to detect or prevent:
   »   the causes before creating failure mode
   »   the failure modes before causing effect
   »   1=Likely to Detect, 10=Not Likely at all to Detect
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 Example Rating Scale
Rating        Severity of Effect        Likelihood of Occurrence                 Ability to Detect

 10       Hazardous without warning                                               Can not detect
                                                 Very high:
                                        Failure is almost inevitable
  9        Hazardous with warning                                        Very remote chance of detection


  8        Loss of primary function                                        Remote chance of detection
                                                 High:
          Reduced primary function          Repeated failures
  7                                                                        Very low chance of detection
               performance

  6       Loss of secondary function                                         Low chance of detection
                                              Moderate:
         Reduced secondary function        Occasional failures
  5                                                                        Moderate chance of detection
               performance
         Minor defect noticed by most
  4                                                                     Moderately high chance of detection
                  customers
         Minor defect noticed by some
  3                                                                          High chance of detection
                  customers                        Low:
            Minor defect noticed by       Relatively few failures
  2                                                                        Very high chance of detection
           discriminating customers

  1               No effect             Remote: Failure is unlikely          Almost certain detection



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FMEA Scoring

  There are a wide variety of scoring “anchors”, both
  quantitative or qualitative.
  Two types of scales are 1-5 or 1-10.
  The 1-5 scale make it easier for the teams to decide
  on scores
  The 1-10 scale allows for better precision in
  estimates and a wide variation in scores.
  The 1-10 scale is generally considered to be the
  best option.




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FMEA Model
Because the Detection score is a little difficult to understand, we will do
 a quick exercise. Give a Detection score for each of the boxes below:

 Prevention
            Cause            Detection
             Cause



                                                     Detection
                                     Failure Mode
                                      Failure Mode
                                       (Defect)                                   Detection
                                         (Defect)
       Material or process
              input                                              Effect
                                                                  Effect




                                    Process Step


                                                           External customer or
                                                           downstream process
                  Controls
                  Controls                                         step
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Answer
    Det = 1
                               Det = 3
    Prevention

                 Cause
                                Detection
                  Cause
                                                 Det = 7
                                                       Detection
                                                                             Det = 10
                                       Failure Mode
                                        Failure Mode
                                         (Defect)                                   Detection
         Material or process               (Defect)
                input                                              Effect
                                                                    Effect




                                       Process Step




                     Controls                                External customer or
                      Controls                               downstream process
                                                                     step




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Quiz!
    Take 5 minutes to fill in the results (internal and external) and
   what action should be taken. Take another 10 minutes with your
          group to discuss. Be prepared to present results.


 O cc   S ev    D et                R esult                 Actions
  1      1       1
  1      1      10
  1      10      1
  1      10     10
 10      1       1
 10      1      10
 10      10      1
 10      10     10



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Dynamics of the RPN

 Occ   Sev    Det               Result                 Actions
  1     1      1           Ideal Situation            No Action
  1     1     10          Assured Mastery             No Action
  1     10     1    Failure does not reach user       No Action
  1     10    10        Failure reaches user                Yes
  10    1      1    Freq. fails, detectable, costly         Yes
  10    1     10      Freq. fails, reaches user             Yes
  10    10     1     Freq. fails w/major impact             Yes
  10    10    10            Big Trouble!                    Yes!



 Which ratings are most affected by design? By manufacturing?


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      FMEA Form - Initial Assessment


                                                                                  S                                                   O                                                           D              R
  Process                                                                                                                                                                                                                 Actions
                  Potential Failure Mode      Potential Failure Effects           E                   Potential Causes                C                       Current Controls                    E              P
 Step/Input                                                                                                                                                                                                            Recommended
                                                                                  V                                                   C                                                           T              N




                                                                                effect to the




                                                                                                                               How often does cause
                                                                           How Severe is the




                                                                                                                                                                                           detect cause or FM?
                                                                                                                                                                                              How well can you
                                                                                 cusotmer?




                                                                                                                                       or FM occur?
  What is the    In what ways does the Key What is the impact on the Key                        What causes the Key Input to                          What are the existing controls and                              What are the actions
process step/    Input go wrong?           Output Variables (Customer                           go wrong?                                             procedures (inspection and test)                                  for reducing the
  Input under                              Requirements) or internal                                                                                  that prevent eith the cause or the                               occurrance of the
investigation?                             requirements?                                                                                              Failure Mode? Should include an                                 Cause, or improving
                                                                                                                                                      SOP number.                                                     detection? Should
                                                                                                                                                                                                                     have actions only on
                                                                                                                                                                                                                      high RPN's or easy
                                                                                                                                                                                                                              fixes.

                                                                                                                                                                                                                 0


                                                                                                                                                                                                                 0


                                                                                                                                                                                                                 0




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FMEA Form - Long Term History


                                            D              R                                                                S   O   D   R
                                                                    Actions
        Current Controls                    E              P                            Resp.         Actions Taken         E   C   E   P
                                                                 Recommended
                                            T              N                                                                V   C   T   N



                                        How well can you
                                     detect cause or FM?
What are the existing controls and                              What are the actions   Whose     What are the completed
procedures (inspection and test)                                  for reducing the   Responsible   actions taken with the
that prevent eith the cause or the                               occurrance of the      for the   recalculated RPN? Be
Failure Mode? Should include an                                 Cause, or improving recommended       sure to include
SOP number.                                                     detection? Should      action?   completion month/year
                                                               have actions only on
                                                                high RPN's or easy
                                                                        fixes.

                                                           0                                                                            0


                                                           0                                                                            0


                                                           0                                                                            0


                                                           0                                                                            0




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Methodology

  Make sure to address safety issues.
  Assume incoming material is perfect and process is not.
  Assume process is perfect and incoming material is not.
  Two major approaches:
   » Starting with the Cause & Effect Matrix
   » Starting with FMEA directly from the Process Map
  We will explain the approach using the C&E matrix, though
  both approaches are very similar
  Spreadsheet tools have been prepared to assist you in the
  preparation of the FMEA




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Starting with C&E Matrix

   Advantage
   » The Cause & Effect Matrix assists the team in defining the
     important issues that the FMEA should address by helping
     to prioritize
   Important customer requirements
   » Process inputs that could potentially impact these
     requirements
   » Prioritizing the Key Process Inputs according to their
     impact on the Output variables (We want to focus on
     Inputs that highly impact a large number of Outputs first)
   » The C&E Matrix also provides quantitative output that can
     be used in the determination of the specific severity
     ratings for the next stage of the FMEA process.



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FMEA - Step by Step

   1. For each Process Input, determine the ways in which the
   input can go wrong (These are Failure Modes)
   2. For each Failure Mode associated with the inputs,
   determine Effects:
   3. Identify potential Causes of each Failure Mode
   4. List the Current Controls for each Cause
   5. Assign Severity, Occurrence and Detection ratings to each
   Cause
   6. Calculate RPN
   7. Determine Recommended Actions to reduce High RPN’     s
   8. Take appropriate Actions and Document
   9. Recalculate RPN’   s




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                    Process Map to be Used in Example
                              INPUTS                                          COMPOUNDING                                                              OUTPUTS

                              Techniques
                              Procedures                                                                                                               Reactivity (Gel)
                              Raw Materials                                                                                                            Viscosity
                              Rework                                                                                                                   Cleanliness
                              Equipment                                                                                                                Color
                                                                                                                                                       Homogeneity
                              Environment
                              Cleanliness                                              Key Outputs                                                     Consistency Batch to Batch
                                                                                                                                                       Digestion Time
                              Dicy Solution Temp
                                                                                                                                                       Temperature


PAPERWORK           TURN STEAM ON
                                        LOAD DMF             LOAD DICY                   LOAD 2MI                                                                                   LOAD DRUM
                    TO DICY TANK                                                                                GET PORTABLE             CLEAN IF              LOAD SOLVENT
                                                                                                                                                                                    STOCK TO        2
                                                                                                                                         NECESSARY             TO PORTABLE
                                                                                                                                                                                    PORTABLE

BILL OF MATERIALS   SCALE ACCURACY
                                      LOAD ACCURACY          LOAD ACCURACY                                        PROPER SIZE
                                                                                       LOAD ACCURACY                                     CLEANLINESS           LOAD ACCURACY        LOAD ACCURACY
ISO PROCEDURES      PREHEATING
                                      CLEANLINESS            ENVIRONMENT                                          REWORK
                                                                                       ENVIRONMENT                                       CROSS                 ENVIRONMENT          ENVIRONMENT
                                                               (HUMIDITY)
REWORK                                                                                   (HUMIDITY)                                      CONTAMINATION
                                      RAW MATERIAL           RAW MATERIAL
                                                                                       RAW MATERIAL                                                            RAW MATERIAL         RAW MATERIAL
                                                             MIXER SPEED
                                                                                       MIXER SPEED                                                                                  MIXER SPEED




                                                   LOAD BULK               PUMP DICY
                                       2                                                              DIGEST                 STAGE               BATCH TO
                                                   MATERIAL TO             SOLUTION TO
                                                                                                                                                 TREATER
                                                   PORTABLE                PORTABLE

                                               LOAD ACCURACY
                                                                         PUMP RATE                  TIME                   TIME
                                               ENVIRONMENT
                                                                         MIXER SPEED                MIX SPEED              MIX SPEED
                                               RAW MATERIAL

                                               MIXER SPEED
                                                                         FILTERING                  VENTING                VENTING
                                                                                                                                                                         Key Inputs
                                                                         TEMPERATURE                ENVIRONMENT            ENVIRONMENT

                                                                         COMPLETE
                                                                         SOLUTION




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C&E Matrix Example
  This is the C&E Matrix for the previous Map with
  the Key Inputs pareto-ized by the Total Score.

          Rating of
          Importance to        9           9            7        10        10               9             3             2          6
          Customer
                               1           2            3         4           5             6             7             8          9    10   11   12   13   14   15




                                                                       Homogeneity




                                                                                                                 Temperature
                                                                                     Consistency

                                                                                                   Digets Time
                                                 Cleanliness
                          Gel Time

                                     Viscosity




                                                                                                                               Solids
                                                               Color
     Process Inputs                                                                                                                                                   Total


          Scales
      1                        9           8            2         1           1             9             1             1          8                                     321
          Accuracy
          DMF Load
      3                        3           8            1         1           1             8             1             3          8                                     255
          Accuracy
          DMF
      4                        1           1            4         2           1             2             1             1          1                                     247
          Cleanliness
          DICY Envir.
      7                        8           5            3         1           1             8             1             1          2                                     247
          Factors
          DICY Load
      6                        9           7            1         1           1             9             1             1          2                                     242
          Accuracy
          DICY Raw
      8                        8           5            1         1           1             9             1             1          2                                     242
          Materials
          DICY Mixer
      9                        1           1            1         1           7             1             1             1          1                                     125
          Speecd
          DMF Raw
      5                        1           1            1         1           1             2             1             1          1                                      74
          Materials



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  FMEA Worksheet
                                       s
  Before we move to the example let’ look at an FMEA worksheet.
The information on this sheet is transferred directly to the FMEA form.
The purpose of this worksheet is to focus the team on the FMEA inputs
and not on scoring. The scoring should be done after the basic inputs
have been made.

                                Failure Modes -
  Process                         What can go
   Step     Key Process Input      wrong?         Effects    Causes        Current Controls




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   Step 1)
     1. For each critical (high value) Process Input, determine the
     ways in which the input can go wrong (These are Failure Modes)

           The first two Key Process Input Variables on the C&E
             Matrix are Scale Accuracy and DMF Load Accuracy.

                               Failure Modes -
Process      Key Process         What can go                                 Current
  Step          Input             wrong?         Effects    Causes           Controls
Steam to
             Scale Accuracy
  DICY




Load DMF   DMF Load Accuracy




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   Step 1) Cont.
           1. For each critical (high value) Process Input, determine the
           ways in which the input can go wrong (These are Failure Modes)

                There are at least three ways that Scale Accuracy
                can fail and one way the Load Accuracy can fail.
                                Failure Modes -
Process       Key Process         What can go                                   Current
  Step           Input             wrong?           Effects    Causes           Controls
Steam to
              Scale Accuracy        Scale > 0
  DICY

                                 Scale Inaccurate


                                 Scale Not Zeroed


Load DMF    DMF Load Accuracy   Mischarge of DMF




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 Step 2)

             2. For each Failure Mode associated
             with the inputs, determine Effects
            These effects are internal requirements for the
              next process as well as customer effects.
                               Failure Modes -
Process      Key Process         What can go                                          Current
  Step          Input             wrong?              Effects         Causes          Controls
Steam to
             Scale Accuracy        Scale > 0       Low DMF Charge
  DICY

                                Scale Inaccurate   High DMF Charge


                                Scale Not Zeroed   Mischarge DMF


                                                   Viscosity out of
Load DMF   DMF Load Accuracy   Mischarge of DMF
                                                        spec




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 Step 3)
   3. Identify potential Causes of each Failure Mode

           In most cases, there will be more than one Cause for a
                             ll
           Failure Mode. We’ keep it simple for this exercise.

                                Failure Modes -
Process       Key Process         What can go                                             Current
  Step           Input             wrong?              Effects            Causes          Controls
Steam to
              Scale Accuracy        Scale > 0       Low DMF Charge     Water in Jacket
  DICY

                                 Scale Inaccurate   High DMF Charge    Tank Hanging Up


                                 Scale Not Zeroed   Mischarge DMF       Faulty Scale


                                                    Viscosity out of
Load DMF    DMF Load Accuracy   Mischarge of DMF                     Equipment Failure
                                                         spec


                                                                      SOP not Followed




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 Step 4)
             4. List the Current Controls for each Cause
      For each Cause we list how we are either preventing or detecting it. We
      would like to place a procedure number wherever we have an SOP.
                               Failure Modes -
Process                          What can go
  Step     Key Process Input      wrong?              Effects             Causes          Current Controls
Steam to                                                                                  Visual Check of Jacket
             Scale Accuracy        Scale > 0       Low DMF Charge      Water in Jacket
 DICY                                                                                          (SOP 5681)
                                                                                           Visual Check (SOP
                                Scale Inaccurate   High DMF Charge    Tank Hanging Up
                                                                                                  5681)

                               Scale Not Zeroed    Mischarge DMF         Faulty Scale             None

                                                                                              Maintenance
                                                   Viscosity out of
Load DMF   DMF Load Accuracy   Mischarge of DMF                       Equipment Failure     Procedure (SOP
                                                        spec
                                                                                           5821)/Visual Check
                                                                                                Operator
                                                                      SOP not Followed        Certification/
                                                                                             Process Audit


 This is how the FMEA identifies initial holes in the Current Control
 Plan. Process teams can start working on these holes right away.
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    Step 5)
                5. Assign Severity, Occurrence and Detection ratings to each Cause


                  We are now ready to assign appropriate criteria. The team
                  then starts scoring each cause to compute an RPN number.


                                                                       S                         O                                       D   R
    Process
                  Potential Failure Mode   Potential Failure Effects   E   Potential Causes      C          Current Controls             E   P
   Step/Input
                                                                       V                         C                                       T   N



   Steam to
  DICY/Scale            Scale > 0             Low DMF Charge           3    Water in Jacket      2   Visual Check of Jacket (SOP 5681)   1   6
   Accuracy

                    Scale Inaccurate          High DMF Charge          3   Tank Hanging Up       2       Visual Check (SOP 5681)         3   18


                    Scale Not Zeroed           Mischarge DMF           3      Faulty Scale       2                None                   9   54

Load DMF/DMF
                                                                                                      Maintenance Procedure (SOP
Load Accuracy      Mischarge of DMF         Viscosity out of spec      7   Equipment Failure     2                                       3   42
                                                                                                           5821)/Visual Check

                                                                                                     Operator Certification/ Process
                                                                       7   SOP not Followed      5                                       5   175
                                                                                                                 Audit




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    Steps 6) and 7)

                                     s
                6. Calculate the RPN’ .
                7. Determine Recommended Actions to reduce High RPN’s

                   Which issues may we want to address first?


                                                                      S                         O                                       D   R
    Process
                 Potential Failure Mode   Potential Failure Effects   E   Potential Causes      C          Current Controls             E   P
   Step/Input
                                                                      V                         C                                       T   N



   Steam to
  DICY/Scale           Scale > 0             Low DMF Charge           3    Water in Jacket      2   Visual Check of Jacket (SOP 5681)   1   6
   Accuracy

                   Scale Inaccurate          High DMF Charge          3   Tank Hanging Up       2       Visual Check (SOP 5681)         3   18


                   Scale Not Zeroed           Mischarge DMF           3      Faulty Scale       2                None                   9   54

Load DMF/DMF
                                                                                                     Maintenance Procedure (SOP
Load Accuracy     Mischarge of DMF         Viscosity out of spec      7   Equipment Failure     2                                       3   42
                                                                                                          5821)/Visual Check

                                                                                                    Operator Certification/ Process
                                                                      7   SOP not Followed      5                                       5   175
                                                                                                                Audit




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      Step 7) Cont.
                7. Determine Recommended Actions to reduce High RPN’s
                            Now fill in recommended actions for top RPN’s.

                                                                     S                       O                                       D    R
   Process                                                                                                                                          Actions
                Potential Failure Mode   Potential Failure Effects   E   Potential Causes    C           Current Controls            E    P
  Step/Input                                                                                                                                     Recommended
                                                                     V                       C                                       T    N



Load DMF/DMF                                                                                                                                 Fool proof this process
                                                                                                 Operator Certification/ Process
Load Accuracy     Mischarge of DMF        Viscosity out of spec      7   SOP not Followed    5                                       5   175 using input from TQL
                                                                                                             Audit
                                                                                                                                             Team
   Steam to                                                                                                                                  Include Daily sign-off of
  DICY/Scale      Scale Not Zeroed           Mischarge DMF           3      Faulty Scale     2                None                   9   54 Scale funtion in Shift
   Accuracy                                                                                                                                  set-up verification.
Load DMF/DMF
                                                                                                  Maintenance Procedure (SOP
Load Accuracy     Mischarge of DMF        Viscosity out of spec      7   Equipment Failure   2                                       3   42
                                                                                                       5821)/Visual Check
   Steam to
  DICY/Scale          Scale > 0             Low DMF Charge           3    Water in Jacket    2   Visual Check of Jacket (SOP 5681)   4   24
   Accuracy
   Steam to
  DICY/Scale       Scale Inaccurate         High DMF Charge          3   Tank Hanging Up     2       Visual Check (SOP 5681)         4   24
   Accuracy




                                               s.
 Actions are recommended for only the high RPN’ The key is FOCUS!
                                                           FOCUS

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Steps 8) and 9)
                     8. Take appropriate Actions and Document
                     9. Recalculate RPN’ s

                       O                                       D    R                                                               S   O    D   R
                                                                              Actions
 Potential Causes      C           Current Controls            E    P                                 Resp.       Actions Taken     E   C    E   P
                                                                           Recommended
                       C                                       T    N                                                               V   C    T   N


                                                                       Fool proof this process SZ             Automated DMF
                           Operator Certification/ Process
 SOP not Followed      5                                       5   175 using input from TQL                   Dispenser 8/96        7   1    2   14
                                       Audit
                                                                       Team
                                                                       Include Daily sign-off of PQ
    Faulty Scale       2                None                   9   54 Scale funtion in Shift                                                     0
                                                                       set-up verification.
                            Maintenance Procedure (SOP
 Equipment Failure     2                                       3   42                                                                            0
                                 5821)/Visual Check

  Water in Jacket      2   Visual Check of Jacket (SOP 5681)   4   24                                                                            0


 Tank Hanging Up       2       Visual Check (SOP 5681)         4   24                                                                            0




We have recorded when the action was taken and the impact on
the RPN. Notice that this is a nice way to track past activities. The
FMEA should grow as new recommended actions are identified,
completed and recorded.
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Exercise


      For the process you used to create the
      process map and C&E Matrix, perform an
      FMEA on the top three input variables
      Report results on a flip chart or in EXCEL
      List lessons learned as part of the team
      presentation




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Approaches to FMEA’s
  Approach One (C&E Matrix Focus)
   »   Start with Key Inputs with the highest scores from the C&E Matrix analysis
   »   Fill out the FMEA worksheet for those Inputs
   »                   s
       Calculate RPN’ and develop recommended actions for the highest RPN’     s
   »   Complete the Process FMEA for other Inputs over time
  Approach Two (Customer Focused):
   »   Fill out the Failure Mode and Effects columns of the worksheet. Copy to FMEA
       form and rate Severity.
   »   For High Severity Ratings, List Causes and rate Occurrence for each Cause
   »   For the highest Severity * Occurrence Ratings, evaluate Current Controls
   »                      s
       For Highest RPN’ develop recommended actions
  Approach Three (Comprehensive)
   »   Good approach for small processes
   »   Fill out the FMEA worksheet beginning with the first process step and ending
       with the last
   »   Score SEV, OCC and DET for all causes
   »   Develop recommended actions for highest RPN’    s
  Approach Four (Super Focused)
   »   Pick the top Pareto defect item (Fiber Breakouts) or Failure Mode (Variability in
       Temperature)
   »   Focus the FMEA process on only that defect or Failure Mode
   »   Purpose: To “Kill” that Failure Mode
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