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FMEA
Failure Mode Effects Analysis
AGENDA
•   Ice breaker
•   Opening
•   DFMEA
•   Break
•   DFMEA exercise
•   Lunch
•   PFMEA
•   Break
•   PFMEA Exercise
•   FMEA Jeopardy
•   Closing and Survey
Quality and Reliability
• Quality is a relative term often based on customer
  perception or the degree to which a product meets
  customer expectations
• Manufacturers have long recognized that products
  can meet specifications and still fail to satisfy
  customer expectations due to:
   – Errors in design
   – Flaws induced by the manufacturing process
   – Environment
   – Product misuse
   – Not understanding customer wants/needs
Quality, Reliability and Failure
           Prevention
• Traditionally quality activities have focused
  on detecting manufacturing and material
  defects that cause failures early in the life
  cycle

• Today, activities focus on failures that
  occur beyond the infant mortality stage

• Emphasis on Failure Prevention
Fmea
Failure Mode & Effects Analysis
           (FMEA)
• FMEA is a systematic method of identifying and
  preventing system, product and process problems
  before they occur
• FMEA is focused on preventing problems,
  enhancing safety, and increasing customer
  satisfaction
• Ideally, FMEA’s are conducted in the product
  design or process development stages, although
  conducting an FMEA on existing products or
  processes may also yield benefits
FMEA/FMECA History
• The history of FMEA/FMECA goes back to
  the early 1950s and 1960s.
  – U.S. Navy Bureau of Aeronautics, followed by
    the Bureau of Naval Weapons:
  – National Aeronautics and Space
    Administration (NASA):
• Department of Defense developed and
  revised the MIL-STD-1629A guidelines
  during the 1970s.
FMEA/FMECA History (continued)
• Ford Motor Company published instruction
  manuals in the 1980s and the automotive
  industry collectively developed standards in
  the 1990s.
• Engineers in a variety of industries have
  adopted and adapted the tool over the years.
Published Guidelines
• J1739 from the SAE for the automotive
  industry.
• AIAG FMEA-3 from the Automotive
  Industry Action Group for the
  automotive industry.
• ARP5580 from the SAE for non-
  automotive applications.
Introduction


            Other Guidelines
• Other industry and company-specific
  guidelines exist. For example:
   – EIA/JEP131 provides guidelines for the
     electronics industry, from the JEDEC/EIA.
   – P-302-720 provides guidelines for NASA’s
     GSFC spacecraft and instruments.
   – SEMATECH 92020963A-ENG for the
     semiconductor equipment industry.
   – Etc…
FMEA is a Tool
• FMEA is a tool that allows you to:
   – Prevent System, Product and Process problems
     before they occur
   – reduce costs by identifying system, product and
     process improvements early in the development
     cycle
   – Create more robust processes
   – Prioritize actions that decrease risk of failure
   – Evaluate the system,design and processes from a
     new vantage point
A Systematic Process
• FMEA provides a systematic process to:
   – Identify and evaluate
      • potential failure modes
      • potential causes of the failure mode
   – Identify and quantify the impact of potential failures
   – Identify and prioritize actions to reduce or eliminate
     the potential failure
   – Implement action plan based on assigned
     responsibilities and completion dates
   – Document the associated activities
Purpose/Benefit
• cost effective tool for maximizing and
  documenting the collective knowledge,
  experience, and insights of the engineering
  and manufacturing community
• format for communication across the
  disciplines
• provides logical, sequential steps for
  specifying product and process areas of
  concern
Benefits of FMEA
• Contributes to improved designs for products and
  processes.
   – Higher reliability
   – Better quality
   – Increased safety
   – Enhanced customer satisfaction
• Contributes to cost savings.
   – Decreases development time and re-design costs
   – Decreases warranty costs
   – Decreases waste, non-value added operations
• Contributes to continuous improvement
Benefits
• Cost benefits associated with FMEA are usually
  expected to come from the ability to identify failure
  modes earlier in the process, when they are less
  expensive to address.
   – “rule of ten”
      • If the issue costs $100 when it is discovered in
        the field, then…
      • It may cost $10 if discovered during the final
        test…
      • But it may cost $1 if discovered during an
        incoming inspection.
      • Even better it may cost $0.10 if discovered
        during the design or process engineering phase.
FMEA as Historical Record
  • Communicate the logic of the
    engineers and related design and
    process considerations

  • Are indispensable resources for new
    engineers and future design and
    process decisions.
SFMEA, DFMEA, and PFMEA
• When it is applied to interaction of parts it is
  called System Failure Mode and Effects Analysis
  (SFMEA)

• Applied to a product it is called a Design Failure
  Mode and Effects Analysis (DFMEA)

• Applied to a process it is called a Process Failure
  Mode and Effects Analysis (PFMEA).
System                  Design                                      Process
   Components              Components
                                                                          Manpower
    Subsystems              Subsystems
                                                                          Machine
   Main Systems            Main Systems
                                                                           Method
                                                                           Material
                                                                         Measurement
      Focus:                 Focus:                                      Environment
 Minimize failure       Minimize failure
  effects on the         effects on the                                     Focus:
      System                Design                                     Minimize failure
                                                                        effects on the
 Objectives/Goal:        Objectives/Goal:
                                                Machines                  Processes
Maximize System         Maximize Design
Quality, reliability,   Quality, reliability,        Tools,           Objectives/Goal:
    Cost and                Cost and             Work Stations,         Maximize
  maintenance             maintenance           Production Lines,      Total Process
                                                Operator Training,   Quality, reliability,
                                                   Processes,            Cost and
                                                     Gauges             maintenance
Why do FMEA’s?
• Examine the system for failures.
• Ensure the specs are clear and assure the
  product works correctly
• ISO requirement-Quality Planning
  – “ensuring the compatibility of the design, the
    production process, installation, servicing, inspection
    and test procedures, and the applicable
    documentation”
What is the objective of FMEA?
• Uncover problems with the product that will
  result in safety hazards, product
  malfunctions, or shortened product life,etc..
• Ask ourselves “how the product will fail”?
• How can we achieve our objective?
  – Respectful communication
  – Make the best of our time, it’s limited; Agree
    for ties to rank on side of caution as appropriate
Potential Applications for FMEA

•   Component Proving Process
•   Outsourcing / Resourcing of product
•   Develop Suppliers to achieve Quality
•   Renaissance / Scorecard Targets
•   Major Process / Equipment / Technology
•   Changes
•   Cost Reductions
•   New Product / Design Analysis
•   Assist in analysis of a flat pareto chart
What tools are available to meet
            our objective?
•   Benchmarking
•   customer warranty reports
•   design checklist or guidelines
•   field complaints
•   internal failure analysis
•   internal test standards
•   lessons learned
•   returned material reports
•   Expert knowledge
What are possible outcomes?
•   Actual/potential failure modes
•   customer and legal design requirements
•   duty cycle requirements
•   product functions
•   key product characteristics
•   Product Verification and Validation
How to Fmea…The Pre-Team
         Meeting
  • Prior to assembling the entire team, it
    may be useful to arrange a meeting
    between two or three key engineers
  • This could include persons
    responsible for design, quality, and
    testing.
How to FMEA.. (cont.)
• The purpose of this meeting is to:
   – Determine scope
   – Gather background reference material
   – Create update block diagrams
   – Identify team members
   – Prepare an agenda, schedule, milestones
   – Identify item functions, failure modes and
     their effects
Block Diagram
• The FMEA should begin with a block
  diagram for the system or subsystem

• This diagram should indicate the functional
  relationship of the parts or components
  appropriate to the level of analysis being
  conducted.
Assumptions of DFMEA
• All systems/components are manufactured
  and assembled as specified by design

• Failure could, but will not necessarily,
  occur
Design FMEA Format
Item                                        C                  O                    D                                   Action Results
                                                 Potential            Current                          Response &
             Potential    Potential     S   l                  c     Design         e   R
                                                 Cause(s)/                                  Recommended Target               S   O   D   R
              Failure    Effect(s) of   e   a                  c      Controls      t   P                           Action
                                                Mechanism(s)                                  Actions   Complete             E   C   E   P
              Mode         Failure      v   s                  u                    e   N                           Taken
                                                 Of Failure                                               Date               V   C   T   N
                                            s                  r                    c
  Function                                                         Prevent Detect
General
Item                                        C                  O                    D                                   Action Results
                                                 Potential            Current                          Response &
             Potential    Potential     S   l                  c     Design         e   R
                                                 Cause(s)/                                  Recommended Target               S   O   D   R
              Failure    Effect(s) of   e   a                  c      Controls      t   P                           Action
                                                Mechanism(s)                                  Actions   Complete             E   C   E   P
              Mode         Failure      v   s                  u                    e   N                           Taken
                                                 Of Failure                                               Date               V   C   T   N
                                            s                  r                    c
  Function                                                         Prevent Detect




     •Every FMEA should have an assumptions document
  attached (electronically if possible) or the first line of the
  FMEA should detail the assumptions and ratings used for the
  FMEA.
     •Product/part names and numbers must be detailed in the
  FMEA header
     •All team members must be listed in the FMEA header
     •Revision date, as appropriate, must be documented in the
  FMEA header
Function-What is the part supposed to do
   in view of customer requirements?
• Describe what the system or component is
  designed to do
  – Include information regarding the environment in
    which the system operates
     • define temperature, pressure, and humidity ranges
• List all functions
• Remember to consider unintended functions
  – position/locate, support/reinforce, seal in/out, lubricate,
    or retain, latch secure
Function
Item                                        C                  O                    D                                   Action Results
                                                 Potential            Current                          Response &
             Potential    Potential     S   l                  c     Design         e   R
                                                 Cause(s)/                                  Recommended Target               S   O   D   R
              Failure    Effect(s) of   e   a                  c      Controls      t   P                           Action
                                                Mechanism(s)                                  Actions   Complete             E   C   E   P
              Mode         Failure      v   s                  u                    e   N                           Taken
                                                 Of Failure                                               Date               V   C   T   N
                                            s                  r                    c
  Function                                                         Prevent Detect




    •EXAMPLE:
    •HVAC system must defog windows and heat or cool cabin to 70
    degrees in all operating conditions (-40 degrees to 100 degrees)
    • - within 3 to 5 minutes
    • or
    • - As specified in functional spec #_______; rev.
  date_________
Potential Failure mode
• Definition: the manner in which a system,
  subsystem, or component could potentially fail to
  meet design intent
• Ask yourself- ”How could this design fail to meet
  each customer requirement?”
• Remember to consider:
   –   absolute failure
   –   partial failure
   –   intermittent failure
   –   over function
   –   degraded function
   –   unintended function
Failure Mode
Item                                        C                  O                    D                                   Action Results
                                                 Potential            Current                          Response &
             Potential    Potential     S   l                  c     Design         e   R
                                                 Cause(s)/                                  Recommended Target               S   O   D   R
              Failure    Effect(s) of   e   a                  c      Controls      t   P                           Action
                                                Mechanism(s)                                  Actions   Complete             E   C   E   P
              Mode         Failure      v   s                  u                    e   N                           Taken
                                                 Of Failure                                               Date               V   C   T   N
                                            s                  r                    c
  Function                                                         Prevent Detect




    •EXAMPLES:
    •HVAC system does not heat vehicle or defog windows
    • HVAC system takes more than 5 minutes to heat vehicle
    •HVAC system does not heat cabin to 70 degrees in below
  zero temperatures
    •HVAC system cools cabin to 50 degrees
    •HVAC system activates rear window defogger
Consider Potential failure modes
            under:
• Operating Conditions
  – hot and cold
  – wet and dry
  – dusty and dirty
• Usage
  – Above average life cycle
  – Harsh environment
  – below average life cycle
Consider Potential failure modes
            under:
• Incorrect service operations
   – Can the wrong part be substituted inadvertently?
   – Can the part be serviced wrong? E.g. upside down,
     backwards, end to end
   – Can the part be omitted?
   – Is the part difficult to assemble?
• Describe or record in physical or technical terms,
  not as symptoms noticeable by the customer.
Potential Effect(s) of Failure
• Definition: effects of the failure mode on the function as
  perceived by the customer
• Ask yourself- ”What would be the result of this failure?”
  or “If the failure occurs then what are the consequences”
• Describe the effects in terms of what the customer might
  experience or notice
• State clearly if the function could impact safety or
  noncompliance to regulations
• Identify all potential customers. The customer may be an
  internal customer, a distributor as well as an end user
• Describe in terms of product performance
Effect(s) of Failure
Item                                        C                  O                    D                                   Action Results
                                                 Potential            Current                          Response &
             Potential    Potential     S   l                  c     Design         e   R
                                                 Cause(s)/                                  Recommended Target               S   O   D   R
              Failure    Effect(s) of   e   a                  c      Controls      t   P                           Action
                                                Mechanism(s)                                  Actions   Complete             E   C   E   P
              Mode         Failure      v   s                  u                    e   N                           Taken
                                                 Of Failure                                               Date               V   C   T   N
                                            s                  r                    c
  Function                                                         Prevent Detect




       •EXAMPLE:
       •Cannot see out of front window
       •Air conditioner makes cab too cold
       •Does not get warm enough
       •Takes too long to heat up
Examples of Potential Effects
• Noise                 •   Intermittent operations
• loss of fluid         •   rough surface
• seizure of adjacent   •   unpleasant odor
  surfaces              •   poor appearance
• loss of function      •   potential safety hazard
• no/low output         •   Customer dissatisfied
• loss of system
Severity
• Definition: assessment of the seriousness of
  the effect(s) of the potential failure mode on
  the next component, subsystem, or
  customer if it occurs
• Severity applies to effects
• For failure modes with multiple effects, rate
  each effect and select the highest rating as
  severity for failure mode
Severity
Item                                        C                  O                    D                                   Action Results
                                                 Potential            Current                          Response &
             Potential    Potential     S   l                  c     Design         e   R
                                                 Cause(s)/                                  Recommended Target               S   O   D   R
              Failure    Effect(s) of   e   a                  c      Controls      t   P                           Action
                                                Mechanism(s)                                  Actions   Complete             E   C   E   P
              Mode         Failure      v   s                  u                    e   N                           Taken
                                                 Of Failure                                               Date               V   C   T   N
                                            s                  r                    c
  Function                                                         Prevent Detect




       •EXAMPLE:
       •Cannot see out of front window – severity 9
       •Air conditioner makes cab too cold – severity 5
       •Does not get warm enough – severity 5
       •Takes too long to heat up – severity 4
Classification
Item                                       C                  O                    D                                   Action Results
                                                 Potential          Current                            Response &
            Potential    Potential     S   l                  c     Design         e   R
                                                Cause(s)/                                  Recommended   Target              S   O      D   R
             Failure    Effect(s) of   e   a                  c     Controls       t   P                            Action
                                               Mechanism(s)                                   Actions   Complete             E   C      E   P
             Mode         Failure      v   s                  u                    e   N                            Taken
                                                Of Failure                                                Date               V   C      T   N
                                           s                  r                    c
 Function                                                         Prevent Detect




     •Classification should be used to define potential critical and significant
  characteristics
     •Critical characteristics (9 or 10 in severity with 2 or more in occurrence-suggested)
  must have associated recommended actions
     •Significant characteristics (4 thru 8 in severity with 4 or more in occurrence
  -suggested) should have associated recommended actions
     •Classification should have defined criteria for application

     •EXAMPLE:
     •Cannot see out of front window – severity 9 – incorrect vent location –
  occurrence 2
     •Air conditioner makes cab too cold – severity 5 - Incorrect routing of vent hoses
  (too close to heat source) – occurrence 6
Potential Cause(s)/Mechanism(s) of
                 failure
• Definition: an indication of a design
  weakness, the consequence of which is the
  failure mode
• Every conceivable failure cause or
  mechanism should be listed
• Each cause or mechanism should be listed
  as concisely and completely as possible so
  efforts can be aimed at pertinent causes
Cause(s) of Failure
Item                                        C                  O                    D                                   Action Results
                                                 Potential            Current                          Response &
             Potential    Potential     S   l                  c     Design         e   R
                                                 Cause(s)/                                  Recommended Target               S   O   D   R
              Failure    Effect(s) of   e   a                  c      Controls      t   P                           Action
                                                Mechanism(s)                                  Actions   Complete             E   C   E   P
              Mode         Failure      v   s                  u                    e   N                           Taken
                                                 Of Failure                                               Date               V   C   T   N
                                            s                  r                    c
  Function                                                         Prevent Detect




    •EXAMPLE:
    •Incorrect location of vents
    •Incorrect routing of vent hoses (too close to heat
  source)
    •Inadequate coolant capacity for application
Potential Cause                           Mechanism
•    Tolerance build up                        •Yield
•    insufficient material
•                                              •Fatigue
     insufficient lubrication capacity
•    Vibration                                 •Material instability
•    Foreign Material
•    Interference                              •Creep
•    Incorrect Material thickness specified
                                               •Wear
•    exposed location
•    temperature expansion                     •Corrosion
•    inadequate diameter
•    Inadequate maintenance instruction
•    Over-stressing
•    Over-load
•    Imbalance
•    Inadequate tolerance
Occurrence
• Definition: likelihood that a specific
  cause/mechanism will occur
• Be consistent when assigning occurrence
• Removing or controlling the
  cause/mechanism though a design change is
  only way to reduce the occurrence rating
Occurrence
Item                                        C                  O                    D                                   Action Results
                                                 Potential            Current                          Response &
             Potential    Potential     S   l                  c     Design         e   R
                                                 Cause(s)/                                  Recommended Target               S   O   D   R
              Failure    Effect(s) of   e   a                  c      Controls      t   P                           Action
                                                Mechanism(s)                                  Actions   Complete             E   C   E   P
              Mode         Failure      v   s                  u                    e   N                           Taken
                                                 Of Failure                                               Date               V   C   T   N
                                            s                  r                    c
  Function                                                         Prevent Detect




   •EXAMPLE:
   •Incorrect location of vents – occurrence 3
   •Incorrect routing of vent hoses (too close to
  heat source) – occurrence 6
   •Inadequate coolant capacity for application –
  occurrence 2
Current Design Controls
• Definition: activities which will assure the design adequacy
  for the failure cause/mechanism under consideration
• Confidence Current Design Controls will detect cause and
  subsequent failure mode prior to production, and/or will
  prevent the cause from occurring
   – If there are more than one control, rate each and select the lowest for
     the detection rating
• Control must be allocated in the plan to be listed, otherwise
  it’s a recommended action
• 3 types of Controls
   – 1. Prevention from occurring or reduction of rate
   – 2. Detect cause mechanism and lead to corrective actions
   – 3. Detect the failure mode, leading to corrective actions
Current Design Controls
Item                                        C                  O                    D                                   Action Results
                                                 Potential            Current                          Response &
             Potential    Potential     S   l                  c     Design         e   R
                                                 Cause(s)/                                  Recommended Target               S   O   D   R
              Failure    Effect(s) of   e   a                  c      Controls      t   P                           Action
                                                Mechanism(s)                                  Actions   Complete             E   C   E   P
              Mode         Failure      v   s                  u                    e   N                           Taken
                                                 Of Failure                                               Date               V   C   T   N
                                            s                  r                    c
  Function                                                         Prevent Detect




       •EXAMPLE:
       •Engineering specifications (P) – preventive control
       •Historical data (P) – preventive control
       •Functional testing (D) – detective control
       •General vehicle durability (D) – detective control
Examples of Controls
• Type 1 control              • Type 2 and 3 controls
   – Warnings which alert        –   Road test
     product user to             –   Design Review
     impending failure           –   Environmental test
   – Fail/safe features          –   fleet test
   – Design                      –   lab test
     procedures/guidelines/
                                 –   field test
     specifications
                                 –   life cycle test
                                 –   load test
Detection
Item                                       C                  O                    D                                   Action Results
                                                 Potential          Current                            Response &
            Potential    Potential     S   l                  c     Design         e   R
                                                Cause(s)/                                  Recommended   Target              S   O      D   R
             Failure    Effect(s) of   e   a                  c     Controls       t   P                            Action
                                               Mechanism(s)                                   Actions   Complete             E   C      E   P
             Mode         Failure      v   s                  u                    e   N                            Taken
                                                Of Failure                                                Date               V   C      T   N
                                           s                  r                    c
 Function                                                         Prevent Detect




    •Detection values should correspond with AIAG, SAE
    •If detection values are based upon internally defined criteria, a reference
  must be included in FMEA to rating table with explanation for use
    •Detection is the value assigned to each of the detective controls
    •Detection values of 1 must eliminate the potential for failures due to design
  deficiency

       •EXAMPLE:
       •Engineering specifications – no detection value
       •Historical data – no detection value
       •Functional testing – detection 3
       •General vehicle durability – detection 5
RPN (Risk Priority Number)
Item                                        C                  O                    D                                   Action Results
                                                 Potential            Current                          Response &
             Potential    Potential     S   l                  c     Design         e   R
                                                 Cause(s)/                                  Recommended Target               S   O   D   R
              Failure    Effect(s) of   e   a                  c      Controls      t   P                           Action
                                                Mechanism(s)                                  Actions   Complete             E   C   E   P
              Mode         Failure      v   s                  u                    e   N                           Taken
                                                 Of Failure                                               Date               V   C   T   N
                                            s                  r                    c
  Function                                                         Prevent Detect




    •Risk Priority Number is a multiplication of the severity,
  occurrence and detection ratings
    •Lowest detection rating is used to determine RPN
    •RPN threshold should not be used as the primary trigger                                                                 for
  definition of recommended actions

    •EXAMPLE:
    •Cannot see out of front window – severity 9, – incorrect                                                                vent
  location – 2, Functional testing – detection 3, RPN - 54
Risk Priority Number(RPN)
• Severity x Occurrence x Detection
• RPN is used to prioritize concerns/actions
• The greater the value of the RPN the greater the
  concern
• RPN ranges from 1-1000
• The team must make efforts to reduce higher
  RPNs through corrective action
• General guideline is over 100 = recommended
  action
Risk Priority Numbers (RPN's)
• Severity
   – Rates the severity of the potential effect of the failure.
• Occurrence
   – Rates the likelihood that the failure will occur.
• Detection
   – Rates the likelihood that the problem will be detected
     before it reaches the end-user/customer.

• RPN rating scales usually range from 1 to 5 or
  from 1 to 10, with the higher number representing
  the higher seriousness or risk.
RPN Considerations
• Rating scale example:
  – Severity = 10 indicates that the effect is very
    serious and is “worse” than Severity = 1.
  – Occurrence = 10 indicates that the likelihood
    of occurrence is very high and is “worse” than
    Occurrence = 1.
  – Detection = 10 indicates that the failure is not
    likely to be detected before it reaches the end
    user and is “worse” than Detection = 1.

     1                      5                     10
RPN Considerations (continued)
• RPN ratings are relative to a particular
  analysis.
  – An RPN in one analysis is comparable to other
    RPNs in the same analysis …
  – … but an RPN may NOT be comparable to
    RPNs in another analysis.


 1                    5                    10
RPN Considerations (continued)
• Because similar RPN's can result in several
  different ways (and represent different types
  of risk), analysts often look at the ratings in
  other ways, such as:
  – Occurrence/Severity Matrix (Severity and
    Occurrence).
  – Individual ratings and various ranking tables.
   1                     5                     10
Recommended Actions
• Definition: tasks recommended for the purpose of
  reducing any or all of the rankings
• Only design revision can bring about a reduction in
  the severity ranking
• Examples of Recommended actions
   – Perform:
      • Designed experiments
      • reliability testing
      • finite element analysis
   – Revise design
   – Revise test plan
   – Revise material specification
Recommended Actions
Item                                        C                  O                    D                                   Action Results
                                                 Potential            Current                          Response &
             Potential    Potential     S   l                  c     Design         e   R
                                                 Cause(s)/                                  Recommended Target               S   O   D   R
              Failure    Effect(s) of   e   a                  c      Controls      t   P                           Action
                                                Mechanism(s)                                  Actions   Complete             E   C   E   P
              Mode         Failure      v   s                  u                    e   N                           Taken
                                                 Of Failure                                               Date               V   C   T   N
                                            s                  r                    c
  Function                                                         Prevent Detect




     •All critical or significant characteristics must have
  recommended actions associated with them
     •Recommended actions should be focused on design, and
  directed toward mitigating the cause of failure, or eliminating                                                            the
  failure mode
     •If recommended actions cannot mitigate or eliminate the
  potential for failure, recommended actions must force
  characteristics to be forwarded to process FMEA for process
  mitigation
Responsibility & Target Completion
                 Date
Item                                        C                  O                    D                                   Action Results
                                                 Potential            Current                          Response &
             Potential    Potential     S   l                  c     Design         e   R
                                                 Cause(s)/                                  Recommended Target               S   O   D   R
              Failure    Effect(s) of   e   a                  c      Controls      t   P                           Action
                                                Mechanism(s)                                  Actions   Complete             E   C   E   P
              Mode         Failure      v   s                  u                    e   N                           Taken
                                                 Of Failure                                               Date               V   C   T   N
                                            s                  r                    c
  Function                                                         Prevent Detect




    •All recommended actions must have a person
  assigned       responsibility for completion of the action
    •Responsibility should be a name, not a title
    •Person listed as responsible for an action must also be
    listed as a team member
    •There must be a completion date accompanying each
  recommended action
Action Results

Item                                        C                  O                    D                                   Action Results
                                                 Potential            Current                          Response &
             Potential    Potential     S   l                  c     Design         e   R
                                                 Cause(s)/                                  Recommended Target               S   O   D   R
              Failure    Effect(s) of   e   a                  c      Controls      t   P                           Action
                                                Mechanism(s)                                  Actions   Complete             E   C   E   P
              Mode         Failure      v   s                  u                    e   N                           Taken
                                                 Of Failure                                               Date               V   C   T   N
                                            s                  r                    c
  Function                                                         Prevent Detect




    •Unless the failure mode has been eliminated, severity
  should not change
    •Occurrence may or may not be lowered based upon the
  results of actions
    •Detection may or may not be lowered based upon the
  results of actions
    •If severity, occurrence or detection ratings are not
  improved, additional recommended actions must to be
  defined
Exercise Design FMEA
• Perform A DFMEA on a pressure cooker
Fmea
Pressure Cooker Safety Features

• 1. Safety valve relieves pressure before it
  reaches dangerous levels.
• 2. Thermostat opens circuit through heating
  coil when the temperature rises above 250°
  C.
• 3. Pressure gage is divided into green and
  red sections. "Danger" is indicated when the
  pointer is in the red section.
Pressure Cooker FMEA

• Define Scope:
• 1. Resolution - The analysis will be
  restricted to the four major subsystems
  (electrical system, safety valve, thermostat,
  and pressure gage).
• 2. Focus - Safety
Pressure cooker block diagram
Process FMEA
• Definition:
  – A documented analysis which begins with a
    teams thoughts concerning requirements that
    could go wrong and ending with defined
    actions which should be implemented to help
    prevent and/or detect problems and their
    causes.
  – A proactive tool to identify concerns with the
    sources of variation and then define and take
    corrective action.
PFMEA as a tool…
• To access risk or the likelihood of
  significant problem
• Trouble shoot problems
• Guide improvement aid in determining
  where to spend time and money
• Capture learning to retain and share
  knowledge and experience
Customer Requirements
        Deign Specifications
     Key Product Characteristics
     Machine Process Capability




Process                            Process           Operator
 Flow          Process FMEA        Control              Job
Diagram                              Plan           Instructions




                                     Conforming Product
                                     Reduced Variation
                                    Customer Satisfaction
Inputs for PMEA
•   Process flow diagram
•   Assembly instructions
•   Design FMEA
•   Current engineering drawings and specifications
•   Data from similar processes
    –   Scrap
    –   Rework
    –   Downtime
    –   Warranty
Process Function Requirement
• Brief description of the manufacturing
  process or operation
• The PFMEA should follow the actual work
  process or sequence, same as the process
  flow diagram
• Begin with a verb
Team Members for a PFMEA
•   Process engineer
•   Manufacturing supervisor
•   Operators
•   Quality
•   Safety
•   Product engineer
•   Customers
•   Suppliers
PFMEA Assumptions
• The design is valid
• All incoming product is to design
  specifications
• Failures can but will not necessarily occur
• Design failures are not covered in a
  PFMEA, they should have been part of the
  design FMEA
Potentional Failure Mode
• How the process or product may fail to
  meet design or quality requirements
• Many process steps or operations will have
  multiple failure modes
• Think about what has gone wrong from past
  experience and what could go wrong
Common Failure Modes
• Assembly                 • Machining
  –   Missing parts          – Too narrow
  –   Damaged                – Too deep
  –   Orientation            – Angle incorrect
  –   Contamination          – Finish not to
  –   Off location             specification
• Torque                     – Flash or not cleaned
  – Loose or over torque
  – Missing fastener
  – Cross threaded
Potentional failure modes
• Sealant                • Drilling holes
  – Missing                 –   Missing
  – Wrong material          –   Location
    applied                 –   Deep or shallow
  – Insufficient or         –   Over/under size
    excessive material      –   Concentricity
  – dry                     –   angle
Potential effects
• Think of what the customer will experience
  – End customer
  – Next user-consequences due to failure mode
• May have several effects but list them in
  same cell
• The worst case impact should be
  documented and rated in severity of effect
Potential Effects
• End user              • Next operation
  – Noise                 –   Cannot assemble
  – Leakage               –   Cannot tap or bore
  – Odor                  –   Cannot connect
  – Poor appearance       –   Cannot fasten
  – Endangers safety      –   Damages equipment
  – Loss of a primary     –   Does not fit
    function              –   Does not match
  – performance           –   Endangers operator
Severity Ranking
• How the effects of a potential failure mode may
  impact the customer
• Only applies to the effect and is assigned with
  regard to any other rating

  Potential effects of    Severity
  failure
  Cannot assemble
  bolt(5)                      10
  Endangers
  operator(10)            Take the highest effect
  Vibration (6)           ranking
Classification
• Use this column to identify any requirement
  that may require additional process control
  – ∙KC∙ - key characteristic
  – ∙F∙ – fit or function
  – ∙S∙ - safety

  – Your company may have a different symbol
Potential Causes
• Cause indicates all the things that may be
  responsible for a failure mode.
• Causes should items that can have action
  completed at the root cause level (controllable in
  the process)
• Every failure mode may have multiple causes
  which creates a new row on the FMEA
• Avoid using operator dependent statements i.e.
  “operator error” use the specific error such as
  “operator incorrectly located part” or “operator
  cross threaded part”
Potential Causes
• Equipment                   • Operator
  – Tool wear                   – Improper torque
  – Inadequate pressure         – Selected wrong part
  – Worn locator                – Incorrect tooling
  – Broken tool                 – Incorrect feed or speed
  – Gauging out of                rate
    calibration                 – Mishandling
  – Inadequate fluid levels     – Assembled upside
                                  down
                                – Assembled backwards
Occurrence Ranking
• How frequent the cause is likely to occur
• Use other data available
  – Past assembly processes
  – SPC
  – Warranty
• Each cause should be ranked according to
  the guideline
Current Process Controls
• All controls should be listed, but ranking should
  occur on detection controls only
• List the controls chronologically
   – Don not include controls that are outside of your plant
• Document both types of process controls
   – Preventative- before the part is made
      • Prevent the cause, use error proofing at the source
   – Detection- after the part is made
      • Detect the cause (mistake proof)
      • Detect the failure mode by inspection
Process Controls
• Preventative                   • Detection
   –   SPC                         –   Functional test
   –   Inspection verification     –   Visual inspection
   –   Work instructions           –   Touch for quality
   –   Maintenance                 –   Gauging
   –   Error proof by design       –   Final test
   –   Method sheets
   –   Set up verification
   –   Operator training
Detection
• Probability the defect will be detected by
  process controls before next or subsequent
  process, or before the part or component
  leaves the manufacturing or assembly
  location
• Likely hood the defect will escape the
  manufacturing location
• Each control receives its own detection
  ranking, use the lowest rating for detection
Risk Priority Number (RPN)
• RPN provides a method for a prioritizing
  process concerns
• High RPN’s warrant corrective actions
• Despite of RPN, special consideration
  should be given when severity is high
  especially in regards to safety
RPN as a measure of risk
• An RPN is like a medical diagnostic,
  predicting the health of the patient
• At times a persons temperature, blood
  pressure, or an EKG can indicate potential
  concerns which could have severe impacts
  or implications
Recommended actions



                Control




                 Influence


 Can’t control or influence at this time
Recommended Action
• Definition: tasks recommended for the
  purpose of reducing any or all of the
  rankings
• Examples of Recommended actions
  – Perform:
     •   Process instructions (P)
     •   Training (P)
     •   Can’t assemble at next station (D)
     •   Visual Inspection (D)
     •   Torque Audit (D)
PMEA as a Info Hub

                              Current or
  Customer      Process
                               Expected     Process          Implementation
   Design        Flow
                                 quality    Changes           and verification
requirements    Diagram
                              performance


                                                             Recommended
                                                            Corrective actions
                 Process FMEA document                              i.e.
                                                             Error proofing


                                              Continuous Improvement Efforts
                Process                       And RPN reduction loop
                Control
                  Plan



                Operator
                   Job                Communication of standard
               Instructions           of work to operators
FMEA process flow
Process FMEA exercise
• Task: Produce and mail sets of contribution
  requests for Breast Cancer research
• Outcome: Professional looking requests to
  support research for a cure, 50 sets of
  information, contribution request, and
  return envelope
Requirements
•   No injury to operators or users
•   Finished dimension fits into envelope
•   All items present (info sheet, contribution form, and return envelope)
    {KEY}
•   All pages in proper order (info sheet, contribution form, return
    envelope) {KEY}
•   No tattered edges
•   No dog eared sheets
•   Items put together in order (info sheet [folded to fit in legal envelope],
    contribution sheet, return envelope) {KEY}
•   General overall neat and professional appearance
•   Proper first class postage on envelopes
•   Breast cancer seal on every envelope sealing the envelope on the back
•   Mailing label, stamp and seal on placed squarely on envelope {KEY}
•   Rubber band sets of 25
Process steps

• Fold information sheet to fit in legal
  envelope
• Collate so each group includes all
  components
• Stuff envelopes
• Affix address, postage, and seal
• Rubber bands sets of 25
• Deliver to post office for mail today by 5
  pm
My hints for a successful FMEA
• Take your time in defining functions
• Ask a lot of questions:
  – Can this happen…..
  – What would happen if the user….
• Make sure everyone is clear on Function
• Be careful when modifying other FMEAs
10 steps to conduct a FMEA
1.    Review the design or process
2.    Brainstorm potential failure modes
3.    List potential failure effects
4.    Assign Severity ratings
5.    Assign Occurrence ratings
6.    Assign detection rating
7.    Calculate RPN
8.    Develop an action plan to address high RPN’s
9.    Take action
10.   Reevaluate the RPN after the actions are completed
Reasons FMEA’s fail
1.   One person is assigned to complete the FMEA.
2.   Not customizing the rating scales with company specific
     data, so they are meaningful to your company
3.   The design or process expert is not included in the
     FMEA or is allowed to dominate the FMEA team
4.   Members of the FMEA team are not trained in the use of
     FMEA, and become frustrated with the process
5.   FMEA team becomes bogged down with minute details
     of design or process, losing sight of the overall objective
Reasons FMEA’s fail
6. Rushing through identifying the failure modes to
     move onto the next step of the FMEA
7. Listing the same potential effect for every failure
     i.e. customer dissatisfied.
8. Stopping the FMEA process when the RPN’s are
     calculated and not continuing with the
     recommended actions.
9. Not reevaluating the high RPN’s after the
     corrective actions have been completed.
Software Recommendations
• Numerous types and specialized formats
• Many have free trials
  –   X-FMEA Reliasoft
  –   FMEA Pro-7
  –   Access Data bases
  –   Excel formats
Fmea
Methods   SOD    Rankings
Potpourri
  $100         $100      $100    $100

  $200         $200      $200    $200

  $300         $300      $300    $300

  $400         $400      $400    $400

  $500         $500      $500    $500



            Sample
Bibliography
• MIL-STD-1629A , Procedures for Performing a Failure
  Mode, Effects and Criticality Analysis, Nov. 1980.
• Sittsamer, Risk Based Error-Proofing, The Luminous
  Group, 2000
• MIL-STD-882B, 1984.
• O’Conner, Practical Reliability Engineering, 3rd edition,
  Revised, John Wiley & Sons,Chichester, England, 1996.
• QS9000 FMEA reference manual (SAE J 1739)
• McDerrmot, Mikulak, and Beauregard, The Basics of
  FMEA, Productivity Inc., 1996.

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Fmea

  • 2. AGENDA • Ice breaker • Opening • DFMEA • Break • DFMEA exercise • Lunch • PFMEA • Break • PFMEA Exercise • FMEA Jeopardy • Closing and Survey
  • 3. Quality and Reliability • Quality is a relative term often based on customer perception or the degree to which a product meets customer expectations • Manufacturers have long recognized that products can meet specifications and still fail to satisfy customer expectations due to: – Errors in design – Flaws induced by the manufacturing process – Environment – Product misuse – Not understanding customer wants/needs
  • 4. Quality, Reliability and Failure Prevention • Traditionally quality activities have focused on detecting manufacturing and material defects that cause failures early in the life cycle • Today, activities focus on failures that occur beyond the infant mortality stage • Emphasis on Failure Prevention
  • 6. Failure Mode & Effects Analysis (FMEA) • FMEA is a systematic method of identifying and preventing system, product and process problems before they occur • FMEA is focused on preventing problems, enhancing safety, and increasing customer satisfaction • Ideally, FMEA’s are conducted in the product design or process development stages, although conducting an FMEA on existing products or processes may also yield benefits
  • 7. FMEA/FMECA History • The history of FMEA/FMECA goes back to the early 1950s and 1960s. – U.S. Navy Bureau of Aeronautics, followed by the Bureau of Naval Weapons: – National Aeronautics and Space Administration (NASA): • Department of Defense developed and revised the MIL-STD-1629A guidelines during the 1970s.
  • 8. FMEA/FMECA History (continued) • Ford Motor Company published instruction manuals in the 1980s and the automotive industry collectively developed standards in the 1990s. • Engineers in a variety of industries have adopted and adapted the tool over the years.
  • 9. Published Guidelines • J1739 from the SAE for the automotive industry. • AIAG FMEA-3 from the Automotive Industry Action Group for the automotive industry. • ARP5580 from the SAE for non- automotive applications.
  • 10. Introduction Other Guidelines • Other industry and company-specific guidelines exist. For example: – EIA/JEP131 provides guidelines for the electronics industry, from the JEDEC/EIA. – P-302-720 provides guidelines for NASA’s GSFC spacecraft and instruments. – SEMATECH 92020963A-ENG for the semiconductor equipment industry. – Etc…
  • 11. FMEA is a Tool • FMEA is a tool that allows you to: – Prevent System, Product and Process problems before they occur – reduce costs by identifying system, product and process improvements early in the development cycle – Create more robust processes – Prioritize actions that decrease risk of failure – Evaluate the system,design and processes from a new vantage point
  • 12. A Systematic Process • FMEA provides a systematic process to: – Identify and evaluate • potential failure modes • potential causes of the failure mode – Identify and quantify the impact of potential failures – Identify and prioritize actions to reduce or eliminate the potential failure – Implement action plan based on assigned responsibilities and completion dates – Document the associated activities
  • 13. Purpose/Benefit • cost effective tool for maximizing and documenting the collective knowledge, experience, and insights of the engineering and manufacturing community • format for communication across the disciplines • provides logical, sequential steps for specifying product and process areas of concern
  • 14. Benefits of FMEA • Contributes to improved designs for products and processes. – Higher reliability – Better quality – Increased safety – Enhanced customer satisfaction • Contributes to cost savings. – Decreases development time and re-design costs – Decreases warranty costs – Decreases waste, non-value added operations • Contributes to continuous improvement
  • 15. Benefits • Cost benefits associated with FMEA are usually expected to come from the ability to identify failure modes earlier in the process, when they are less expensive to address. – “rule of ten” • If the issue costs $100 when it is discovered in the field, then… • It may cost $10 if discovered during the final test… • But it may cost $1 if discovered during an incoming inspection. • Even better it may cost $0.10 if discovered during the design or process engineering phase.
  • 16. FMEA as Historical Record • Communicate the logic of the engineers and related design and process considerations • Are indispensable resources for new engineers and future design and process decisions.
  • 17. SFMEA, DFMEA, and PFMEA • When it is applied to interaction of parts it is called System Failure Mode and Effects Analysis (SFMEA) • Applied to a product it is called a Design Failure Mode and Effects Analysis (DFMEA) • Applied to a process it is called a Process Failure Mode and Effects Analysis (PFMEA).
  • 18. System Design Process Components Components Manpower Subsystems Subsystems Machine Main Systems Main Systems Method Material Measurement Focus: Focus: Environment Minimize failure Minimize failure effects on the effects on the Focus: System Design Minimize failure effects on the Objectives/Goal: Objectives/Goal: Machines Processes Maximize System Maximize Design Quality, reliability, Quality, reliability, Tools, Objectives/Goal: Cost and Cost and Work Stations, Maximize maintenance maintenance Production Lines, Total Process Operator Training, Quality, reliability, Processes, Cost and Gauges maintenance
  • 19. Why do FMEA’s? • Examine the system for failures. • Ensure the specs are clear and assure the product works correctly • ISO requirement-Quality Planning – “ensuring the compatibility of the design, the production process, installation, servicing, inspection and test procedures, and the applicable documentation”
  • 20. What is the objective of FMEA? • Uncover problems with the product that will result in safety hazards, product malfunctions, or shortened product life,etc.. • Ask ourselves “how the product will fail”? • How can we achieve our objective? – Respectful communication – Make the best of our time, it’s limited; Agree for ties to rank on side of caution as appropriate
  • 21. Potential Applications for FMEA • Component Proving Process • Outsourcing / Resourcing of product • Develop Suppliers to achieve Quality • Renaissance / Scorecard Targets • Major Process / Equipment / Technology • Changes • Cost Reductions • New Product / Design Analysis • Assist in analysis of a flat pareto chart
  • 22. What tools are available to meet our objective? • Benchmarking • customer warranty reports • design checklist or guidelines • field complaints • internal failure analysis • internal test standards • lessons learned • returned material reports • Expert knowledge
  • 23. What are possible outcomes? • Actual/potential failure modes • customer and legal design requirements • duty cycle requirements • product functions • key product characteristics • Product Verification and Validation
  • 24. How to Fmea…The Pre-Team Meeting • Prior to assembling the entire team, it may be useful to arrange a meeting between two or three key engineers • This could include persons responsible for design, quality, and testing.
  • 25. How to FMEA.. (cont.) • The purpose of this meeting is to: – Determine scope – Gather background reference material – Create update block diagrams – Identify team members – Prepare an agenda, schedule, milestones – Identify item functions, failure modes and their effects
  • 26. Block Diagram • The FMEA should begin with a block diagram for the system or subsystem • This diagram should indicate the functional relationship of the parts or components appropriate to the level of analysis being conducted.
  • 27. Assumptions of DFMEA • All systems/components are manufactured and assembled as specified by design • Failure could, but will not necessarily, occur
  • 28. Design FMEA Format Item C O D Action Results Potential Current Response & Potential Potential S l c Design e R Cause(s)/ Recommended Target S O D R Failure Effect(s) of e a c Controls t P Action Mechanism(s) Actions Complete E C E P Mode Failure v s u e N Taken Of Failure Date V C T N s r c Function Prevent Detect
  • 29. General Item C O D Action Results Potential Current Response & Potential Potential S l c Design e R Cause(s)/ Recommended Target S O D R Failure Effect(s) of e a c Controls t P Action Mechanism(s) Actions Complete E C E P Mode Failure v s u e N Taken Of Failure Date V C T N s r c Function Prevent Detect •Every FMEA should have an assumptions document attached (electronically if possible) or the first line of the FMEA should detail the assumptions and ratings used for the FMEA. •Product/part names and numbers must be detailed in the FMEA header •All team members must be listed in the FMEA header •Revision date, as appropriate, must be documented in the FMEA header
  • 30. Function-What is the part supposed to do in view of customer requirements? • Describe what the system or component is designed to do – Include information regarding the environment in which the system operates • define temperature, pressure, and humidity ranges • List all functions • Remember to consider unintended functions – position/locate, support/reinforce, seal in/out, lubricate, or retain, latch secure
  • 31. Function Item C O D Action Results Potential Current Response & Potential Potential S l c Design e R Cause(s)/ Recommended Target S O D R Failure Effect(s) of e a c Controls t P Action Mechanism(s) Actions Complete E C E P Mode Failure v s u e N Taken Of Failure Date V C T N s r c Function Prevent Detect •EXAMPLE: •HVAC system must defog windows and heat or cool cabin to 70 degrees in all operating conditions (-40 degrees to 100 degrees) • - within 3 to 5 minutes • or • - As specified in functional spec #_______; rev. date_________
  • 32. Potential Failure mode • Definition: the manner in which a system, subsystem, or component could potentially fail to meet design intent • Ask yourself- ”How could this design fail to meet each customer requirement?” • Remember to consider: – absolute failure – partial failure – intermittent failure – over function – degraded function – unintended function
  • 33. Failure Mode Item C O D Action Results Potential Current Response & Potential Potential S l c Design e R Cause(s)/ Recommended Target S O D R Failure Effect(s) of e a c Controls t P Action Mechanism(s) Actions Complete E C E P Mode Failure v s u e N Taken Of Failure Date V C T N s r c Function Prevent Detect •EXAMPLES: •HVAC system does not heat vehicle or defog windows • HVAC system takes more than 5 minutes to heat vehicle •HVAC system does not heat cabin to 70 degrees in below zero temperatures •HVAC system cools cabin to 50 degrees •HVAC system activates rear window defogger
  • 34. Consider Potential failure modes under: • Operating Conditions – hot and cold – wet and dry – dusty and dirty • Usage – Above average life cycle – Harsh environment – below average life cycle
  • 35. Consider Potential failure modes under: • Incorrect service operations – Can the wrong part be substituted inadvertently? – Can the part be serviced wrong? E.g. upside down, backwards, end to end – Can the part be omitted? – Is the part difficult to assemble? • Describe or record in physical or technical terms, not as symptoms noticeable by the customer.
  • 36. Potential Effect(s) of Failure • Definition: effects of the failure mode on the function as perceived by the customer • Ask yourself- ”What would be the result of this failure?” or “If the failure occurs then what are the consequences” • Describe the effects in terms of what the customer might experience or notice • State clearly if the function could impact safety or noncompliance to regulations • Identify all potential customers. The customer may be an internal customer, a distributor as well as an end user • Describe in terms of product performance
  • 37. Effect(s) of Failure Item C O D Action Results Potential Current Response & Potential Potential S l c Design e R Cause(s)/ Recommended Target S O D R Failure Effect(s) of e a c Controls t P Action Mechanism(s) Actions Complete E C E P Mode Failure v s u e N Taken Of Failure Date V C T N s r c Function Prevent Detect •EXAMPLE: •Cannot see out of front window •Air conditioner makes cab too cold •Does not get warm enough •Takes too long to heat up
  • 38. Examples of Potential Effects • Noise • Intermittent operations • loss of fluid • rough surface • seizure of adjacent • unpleasant odor surfaces • poor appearance • loss of function • potential safety hazard • no/low output • Customer dissatisfied • loss of system
  • 39. Severity • Definition: assessment of the seriousness of the effect(s) of the potential failure mode on the next component, subsystem, or customer if it occurs • Severity applies to effects • For failure modes with multiple effects, rate each effect and select the highest rating as severity for failure mode
  • 40. Severity Item C O D Action Results Potential Current Response & Potential Potential S l c Design e R Cause(s)/ Recommended Target S O D R Failure Effect(s) of e a c Controls t P Action Mechanism(s) Actions Complete E C E P Mode Failure v s u e N Taken Of Failure Date V C T N s r c Function Prevent Detect •EXAMPLE: •Cannot see out of front window – severity 9 •Air conditioner makes cab too cold – severity 5 •Does not get warm enough – severity 5 •Takes too long to heat up – severity 4
  • 41. Classification Item C O D Action Results Potential Current Response & Potential Potential S l c Design e R Cause(s)/ Recommended Target S O D R Failure Effect(s) of e a c Controls t P Action Mechanism(s) Actions Complete E C E P Mode Failure v s u e N Taken Of Failure Date V C T N s r c Function Prevent Detect •Classification should be used to define potential critical and significant characteristics •Critical characteristics (9 or 10 in severity with 2 or more in occurrence-suggested) must have associated recommended actions •Significant characteristics (4 thru 8 in severity with 4 or more in occurrence -suggested) should have associated recommended actions •Classification should have defined criteria for application •EXAMPLE: •Cannot see out of front window – severity 9 – incorrect vent location – occurrence 2 •Air conditioner makes cab too cold – severity 5 - Incorrect routing of vent hoses (too close to heat source) – occurrence 6
  • 42. Potential Cause(s)/Mechanism(s) of failure • Definition: an indication of a design weakness, the consequence of which is the failure mode • Every conceivable failure cause or mechanism should be listed • Each cause or mechanism should be listed as concisely and completely as possible so efforts can be aimed at pertinent causes
  • 43. Cause(s) of Failure Item C O D Action Results Potential Current Response & Potential Potential S l c Design e R Cause(s)/ Recommended Target S O D R Failure Effect(s) of e a c Controls t P Action Mechanism(s) Actions Complete E C E P Mode Failure v s u e N Taken Of Failure Date V C T N s r c Function Prevent Detect •EXAMPLE: •Incorrect location of vents •Incorrect routing of vent hoses (too close to heat source) •Inadequate coolant capacity for application
  • 44. Potential Cause Mechanism • Tolerance build up •Yield • insufficient material • •Fatigue insufficient lubrication capacity • Vibration •Material instability • Foreign Material • Interference •Creep • Incorrect Material thickness specified •Wear • exposed location • temperature expansion •Corrosion • inadequate diameter • Inadequate maintenance instruction • Over-stressing • Over-load • Imbalance • Inadequate tolerance
  • 45. Occurrence • Definition: likelihood that a specific cause/mechanism will occur • Be consistent when assigning occurrence • Removing or controlling the cause/mechanism though a design change is only way to reduce the occurrence rating
  • 46. Occurrence Item C O D Action Results Potential Current Response & Potential Potential S l c Design e R Cause(s)/ Recommended Target S O D R Failure Effect(s) of e a c Controls t P Action Mechanism(s) Actions Complete E C E P Mode Failure v s u e N Taken Of Failure Date V C T N s r c Function Prevent Detect •EXAMPLE: •Incorrect location of vents – occurrence 3 •Incorrect routing of vent hoses (too close to heat source) – occurrence 6 •Inadequate coolant capacity for application – occurrence 2
  • 47. Current Design Controls • Definition: activities which will assure the design adequacy for the failure cause/mechanism under consideration • Confidence Current Design Controls will detect cause and subsequent failure mode prior to production, and/or will prevent the cause from occurring – If there are more than one control, rate each and select the lowest for the detection rating • Control must be allocated in the plan to be listed, otherwise it’s a recommended action • 3 types of Controls – 1. Prevention from occurring or reduction of rate – 2. Detect cause mechanism and lead to corrective actions – 3. Detect the failure mode, leading to corrective actions
  • 48. Current Design Controls Item C O D Action Results Potential Current Response & Potential Potential S l c Design e R Cause(s)/ Recommended Target S O D R Failure Effect(s) of e a c Controls t P Action Mechanism(s) Actions Complete E C E P Mode Failure v s u e N Taken Of Failure Date V C T N s r c Function Prevent Detect •EXAMPLE: •Engineering specifications (P) – preventive control •Historical data (P) – preventive control •Functional testing (D) – detective control •General vehicle durability (D) – detective control
  • 49. Examples of Controls • Type 1 control • Type 2 and 3 controls – Warnings which alert – Road test product user to – Design Review impending failure – Environmental test – Fail/safe features – fleet test – Design – lab test procedures/guidelines/ – field test specifications – life cycle test – load test
  • 50. Detection Item C O D Action Results Potential Current Response & Potential Potential S l c Design e R Cause(s)/ Recommended Target S O D R Failure Effect(s) of e a c Controls t P Action Mechanism(s) Actions Complete E C E P Mode Failure v s u e N Taken Of Failure Date V C T N s r c Function Prevent Detect •Detection values should correspond with AIAG, SAE •If detection values are based upon internally defined criteria, a reference must be included in FMEA to rating table with explanation for use •Detection is the value assigned to each of the detective controls •Detection values of 1 must eliminate the potential for failures due to design deficiency •EXAMPLE: •Engineering specifications – no detection value •Historical data – no detection value •Functional testing – detection 3 •General vehicle durability – detection 5
  • 51. RPN (Risk Priority Number) Item C O D Action Results Potential Current Response & Potential Potential S l c Design e R Cause(s)/ Recommended Target S O D R Failure Effect(s) of e a c Controls t P Action Mechanism(s) Actions Complete E C E P Mode Failure v s u e N Taken Of Failure Date V C T N s r c Function Prevent Detect •Risk Priority Number is a multiplication of the severity, occurrence and detection ratings •Lowest detection rating is used to determine RPN •RPN threshold should not be used as the primary trigger for definition of recommended actions •EXAMPLE: •Cannot see out of front window – severity 9, – incorrect vent location – 2, Functional testing – detection 3, RPN - 54
  • 52. Risk Priority Number(RPN) • Severity x Occurrence x Detection • RPN is used to prioritize concerns/actions • The greater the value of the RPN the greater the concern • RPN ranges from 1-1000 • The team must make efforts to reduce higher RPNs through corrective action • General guideline is over 100 = recommended action
  • 53. Risk Priority Numbers (RPN's) • Severity – Rates the severity of the potential effect of the failure. • Occurrence – Rates the likelihood that the failure will occur. • Detection – Rates the likelihood that the problem will be detected before it reaches the end-user/customer. • RPN rating scales usually range from 1 to 5 or from 1 to 10, with the higher number representing the higher seriousness or risk.
  • 54. RPN Considerations • Rating scale example: – Severity = 10 indicates that the effect is very serious and is “worse” than Severity = 1. – Occurrence = 10 indicates that the likelihood of occurrence is very high and is “worse” than Occurrence = 1. – Detection = 10 indicates that the failure is not likely to be detected before it reaches the end user and is “worse” than Detection = 1. 1 5 10
  • 55. RPN Considerations (continued) • RPN ratings are relative to a particular analysis. – An RPN in one analysis is comparable to other RPNs in the same analysis … – … but an RPN may NOT be comparable to RPNs in another analysis. 1 5 10
  • 56. RPN Considerations (continued) • Because similar RPN's can result in several different ways (and represent different types of risk), analysts often look at the ratings in other ways, such as: – Occurrence/Severity Matrix (Severity and Occurrence). – Individual ratings and various ranking tables. 1 5 10
  • 57. Recommended Actions • Definition: tasks recommended for the purpose of reducing any or all of the rankings • Only design revision can bring about a reduction in the severity ranking • Examples of Recommended actions – Perform: • Designed experiments • reliability testing • finite element analysis – Revise design – Revise test plan – Revise material specification
  • 58. Recommended Actions Item C O D Action Results Potential Current Response & Potential Potential S l c Design e R Cause(s)/ Recommended Target S O D R Failure Effect(s) of e a c Controls t P Action Mechanism(s) Actions Complete E C E P Mode Failure v s u e N Taken Of Failure Date V C T N s r c Function Prevent Detect •All critical or significant characteristics must have recommended actions associated with them •Recommended actions should be focused on design, and directed toward mitigating the cause of failure, or eliminating the failure mode •If recommended actions cannot mitigate or eliminate the potential for failure, recommended actions must force characteristics to be forwarded to process FMEA for process mitigation
  • 59. Responsibility & Target Completion Date Item C O D Action Results Potential Current Response & Potential Potential S l c Design e R Cause(s)/ Recommended Target S O D R Failure Effect(s) of e a c Controls t P Action Mechanism(s) Actions Complete E C E P Mode Failure v s u e N Taken Of Failure Date V C T N s r c Function Prevent Detect •All recommended actions must have a person assigned responsibility for completion of the action •Responsibility should be a name, not a title •Person listed as responsible for an action must also be listed as a team member •There must be a completion date accompanying each recommended action
  • 60. Action Results Item C O D Action Results Potential Current Response & Potential Potential S l c Design e R Cause(s)/ Recommended Target S O D R Failure Effect(s) of e a c Controls t P Action Mechanism(s) Actions Complete E C E P Mode Failure v s u e N Taken Of Failure Date V C T N s r c Function Prevent Detect •Unless the failure mode has been eliminated, severity should not change •Occurrence may or may not be lowered based upon the results of actions •Detection may or may not be lowered based upon the results of actions •If severity, occurrence or detection ratings are not improved, additional recommended actions must to be defined
  • 61. Exercise Design FMEA • Perform A DFMEA on a pressure cooker
  • 63. Pressure Cooker Safety Features • 1. Safety valve relieves pressure before it reaches dangerous levels. • 2. Thermostat opens circuit through heating coil when the temperature rises above 250° C. • 3. Pressure gage is divided into green and red sections. "Danger" is indicated when the pointer is in the red section.
  • 64. Pressure Cooker FMEA • Define Scope: • 1. Resolution - The analysis will be restricted to the four major subsystems (electrical system, safety valve, thermostat, and pressure gage). • 2. Focus - Safety
  • 66. Process FMEA • Definition: – A documented analysis which begins with a teams thoughts concerning requirements that could go wrong and ending with defined actions which should be implemented to help prevent and/or detect problems and their causes. – A proactive tool to identify concerns with the sources of variation and then define and take corrective action.
  • 67. PFMEA as a tool… • To access risk or the likelihood of significant problem • Trouble shoot problems • Guide improvement aid in determining where to spend time and money • Capture learning to retain and share knowledge and experience
  • 68. Customer Requirements Deign Specifications Key Product Characteristics Machine Process Capability Process Process Operator Flow Process FMEA Control Job Diagram Plan Instructions Conforming Product Reduced Variation Customer Satisfaction
  • 69. Inputs for PMEA • Process flow diagram • Assembly instructions • Design FMEA • Current engineering drawings and specifications • Data from similar processes – Scrap – Rework – Downtime – Warranty
  • 70. Process Function Requirement • Brief description of the manufacturing process or operation • The PFMEA should follow the actual work process or sequence, same as the process flow diagram • Begin with a verb
  • 71. Team Members for a PFMEA • Process engineer • Manufacturing supervisor • Operators • Quality • Safety • Product engineer • Customers • Suppliers
  • 72. PFMEA Assumptions • The design is valid • All incoming product is to design specifications • Failures can but will not necessarily occur • Design failures are not covered in a PFMEA, they should have been part of the design FMEA
  • 73. Potentional Failure Mode • How the process or product may fail to meet design or quality requirements • Many process steps or operations will have multiple failure modes • Think about what has gone wrong from past experience and what could go wrong
  • 74. Common Failure Modes • Assembly • Machining – Missing parts – Too narrow – Damaged – Too deep – Orientation – Angle incorrect – Contamination – Finish not to – Off location specification • Torque – Flash or not cleaned – Loose or over torque – Missing fastener – Cross threaded
  • 75. Potentional failure modes • Sealant • Drilling holes – Missing – Missing – Wrong material – Location applied – Deep or shallow – Insufficient or – Over/under size excessive material – Concentricity – dry – angle
  • 76. Potential effects • Think of what the customer will experience – End customer – Next user-consequences due to failure mode • May have several effects but list them in same cell • The worst case impact should be documented and rated in severity of effect
  • 77. Potential Effects • End user • Next operation – Noise – Cannot assemble – Leakage – Cannot tap or bore – Odor – Cannot connect – Poor appearance – Cannot fasten – Endangers safety – Damages equipment – Loss of a primary – Does not fit function – Does not match – performance – Endangers operator
  • 78. Severity Ranking • How the effects of a potential failure mode may impact the customer • Only applies to the effect and is assigned with regard to any other rating Potential effects of Severity failure Cannot assemble bolt(5) 10 Endangers operator(10) Take the highest effect Vibration (6) ranking
  • 79. Classification • Use this column to identify any requirement that may require additional process control – ∙KC∙ - key characteristic – ∙F∙ – fit or function – ∙S∙ - safety – Your company may have a different symbol
  • 80. Potential Causes • Cause indicates all the things that may be responsible for a failure mode. • Causes should items that can have action completed at the root cause level (controllable in the process) • Every failure mode may have multiple causes which creates a new row on the FMEA • Avoid using operator dependent statements i.e. “operator error” use the specific error such as “operator incorrectly located part” or “operator cross threaded part”
  • 81. Potential Causes • Equipment • Operator – Tool wear – Improper torque – Inadequate pressure – Selected wrong part – Worn locator – Incorrect tooling – Broken tool – Incorrect feed or speed – Gauging out of rate calibration – Mishandling – Inadequate fluid levels – Assembled upside down – Assembled backwards
  • 82. Occurrence Ranking • How frequent the cause is likely to occur • Use other data available – Past assembly processes – SPC – Warranty • Each cause should be ranked according to the guideline
  • 83. Current Process Controls • All controls should be listed, but ranking should occur on detection controls only • List the controls chronologically – Don not include controls that are outside of your plant • Document both types of process controls – Preventative- before the part is made • Prevent the cause, use error proofing at the source – Detection- after the part is made • Detect the cause (mistake proof) • Detect the failure mode by inspection
  • 84. Process Controls • Preventative • Detection – SPC – Functional test – Inspection verification – Visual inspection – Work instructions – Touch for quality – Maintenance – Gauging – Error proof by design – Final test – Method sheets – Set up verification – Operator training
  • 85. Detection • Probability the defect will be detected by process controls before next or subsequent process, or before the part or component leaves the manufacturing or assembly location • Likely hood the defect will escape the manufacturing location • Each control receives its own detection ranking, use the lowest rating for detection
  • 86. Risk Priority Number (RPN) • RPN provides a method for a prioritizing process concerns • High RPN’s warrant corrective actions • Despite of RPN, special consideration should be given when severity is high especially in regards to safety
  • 87. RPN as a measure of risk • An RPN is like a medical diagnostic, predicting the health of the patient • At times a persons temperature, blood pressure, or an EKG can indicate potential concerns which could have severe impacts or implications
  • 88. Recommended actions Control Influence Can’t control or influence at this time
  • 89. Recommended Action • Definition: tasks recommended for the purpose of reducing any or all of the rankings • Examples of Recommended actions – Perform: • Process instructions (P) • Training (P) • Can’t assemble at next station (D) • Visual Inspection (D) • Torque Audit (D)
  • 90. PMEA as a Info Hub Current or Customer Process Expected Process Implementation Design Flow quality Changes and verification requirements Diagram performance Recommended Corrective actions Process FMEA document i.e. Error proofing Continuous Improvement Efforts Process And RPN reduction loop Control Plan Operator Job Communication of standard Instructions of work to operators
  • 92. Process FMEA exercise • Task: Produce and mail sets of contribution requests for Breast Cancer research • Outcome: Professional looking requests to support research for a cure, 50 sets of information, contribution request, and return envelope
  • 93. Requirements • No injury to operators or users • Finished dimension fits into envelope • All items present (info sheet, contribution form, and return envelope) {KEY} • All pages in proper order (info sheet, contribution form, return envelope) {KEY} • No tattered edges • No dog eared sheets • Items put together in order (info sheet [folded to fit in legal envelope], contribution sheet, return envelope) {KEY} • General overall neat and professional appearance • Proper first class postage on envelopes • Breast cancer seal on every envelope sealing the envelope on the back • Mailing label, stamp and seal on placed squarely on envelope {KEY} • Rubber band sets of 25
  • 94. Process steps • Fold information sheet to fit in legal envelope • Collate so each group includes all components • Stuff envelopes • Affix address, postage, and seal • Rubber bands sets of 25 • Deliver to post office for mail today by 5 pm
  • 95. My hints for a successful FMEA • Take your time in defining functions • Ask a lot of questions: – Can this happen….. – What would happen if the user…. • Make sure everyone is clear on Function • Be careful when modifying other FMEAs
  • 96. 10 steps to conduct a FMEA 1. Review the design or process 2. Brainstorm potential failure modes 3. List potential failure effects 4. Assign Severity ratings 5. Assign Occurrence ratings 6. Assign detection rating 7. Calculate RPN 8. Develop an action plan to address high RPN’s 9. Take action 10. Reevaluate the RPN after the actions are completed
  • 97. Reasons FMEA’s fail 1. One person is assigned to complete the FMEA. 2. Not customizing the rating scales with company specific data, so they are meaningful to your company 3. The design or process expert is not included in the FMEA or is allowed to dominate the FMEA team 4. Members of the FMEA team are not trained in the use of FMEA, and become frustrated with the process 5. FMEA team becomes bogged down with minute details of design or process, losing sight of the overall objective
  • 98. Reasons FMEA’s fail 6. Rushing through identifying the failure modes to move onto the next step of the FMEA 7. Listing the same potential effect for every failure i.e. customer dissatisfied. 8. Stopping the FMEA process when the RPN’s are calculated and not continuing with the recommended actions. 9. Not reevaluating the high RPN’s after the corrective actions have been completed.
  • 99. Software Recommendations • Numerous types and specialized formats • Many have free trials – X-FMEA Reliasoft – FMEA Pro-7 – Access Data bases – Excel formats
  • 101. Methods SOD Rankings Potpourri $100 $100 $100 $100 $200 $200 $200 $200 $300 $300 $300 $300 $400 $400 $400 $400 $500 $500 $500 $500 Sample
  • 102. Bibliography • MIL-STD-1629A , Procedures for Performing a Failure Mode, Effects and Criticality Analysis, Nov. 1980. • Sittsamer, Risk Based Error-Proofing, The Luminous Group, 2000 • MIL-STD-882B, 1984. • O’Conner, Practical Reliability Engineering, 3rd edition, Revised, John Wiley & Sons,Chichester, England, 1996. • QS9000 FMEA reference manual (SAE J 1739) • McDerrmot, Mikulak, and Beauregard, The Basics of FMEA, Productivity Inc., 1996.

Notes de l'éditeur

  1. As a class ask what would a block diagram consist of for the powertrain system of a bike & it’s functions? Now HAND OUT DFMEA FORM - talk through header info. - After header info go through columns of FMEA & explain (USE BIKE SFMEA to explain & Ranking sheets (talk through local, next, end user -Review all columns including the RPN reduction columns - Now as a class, start with highest RPN's & give recommended actions to reduce (360) -- talk about what would do to reduce severity, occurrence etc.