POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS (DESIGN FMEA)
____ System
____ Subsystem                                                                                                                                                                                            FMEA Number:
____ Component _______________________________                                         Design Responsibility                                                                                                  Prepared by:
Model Year(s)/Vehicle(s)                                                               Key Date                                                                                                               Date (Orig.)
Core Team:                                                                                                                                                                                                    Date (Rev.)
                                                                                                                                                                                                              Responsibility             Action Results
                                                                                                                                                                            DETECT
                                                                                                                     OCCUR
                                                                                                                                                                                             Recommended
                                                                               CLASS
                                                                                                                                                                                     RPN #
                                                                                           Potential Cause(s)/               Current Design Controls    Current Design                                          & Target
                                                                         SEV
Item/ Function   Potential Failure Mode Potential Effect(s) of Failure                                                                                                                        Action(s) and
                                                                                        Mechanism(s) of Failure(s)                 Prevention          Controls Detection                                      Completion
                                                                                                                                                                                                                                                      OCC
                                                                                                                                                                                                                                                                  RPN
                                                                                                                                                                                                                                                SEV
                                                                                                                                                                                                                                                            DET
                                                                                                                                                                                             Action Results                    Actions Taken
                                                                                                                                                                                                                  Date
                                                                                                                                         Page 1 of 9
SUGGESTED DESIGN FMEA SEVERITY RANKINGS
Severity Effect       Criteria: Severity of Effect on Product (Customer Effect)               Ranking
 Failure to Meet Potential failure mode affects safe vehicle operation and/or involves
                                                                                                10
  Safety and/or  noncompliance with government regulation without warning
   Regulatory    Potential failure mode affects safe vehicle operation and/or involves
  Requirements                                                                                   9
                 noncompliance with government regulation with warning
                 Loss of primary function (Vehicle inoperable, does not affect safe vehicle
     Loss or                                                                                     8
                 operation).
 Degradation of
Primary Function Degradation of primary function (vehicle operable, but at reduced level of      7
                 performance).
     Loss or     Loss of secondary function (vehicle operable, but comfort/convenience
                                                                                                 6
 Degradation of functions inoperable).
   Secondary     Degradation of secondary function (vehicle operable, but
    Function                                                                                     5
                 comfort/convenience functions at reduced level of performance).
                 Appearance or Audible Noise, vehicle operable, item does not conform and
                                                                                                 4
                 noticed by most customers (>75%).
                 Appearance or Audible Noise, vehicle operable, item does not conform and
   Annoyance                                                                                     3
                 noticed by many customers (50%)
                 Appearance or Audible Noise, vehicle operable, item does not conform and
                                                                                                 2
                 noticed by discriminating customers (<25%).
    No effect    No discernible effect.                                                          1
SUGGESTED DESIGN FMEA OCCURRENCE RANKINGS
Probability of Failure               Likely Failure Rates      Likely Failure Rates     Ppk      Ranking
                              > 100 per thousand pieces           More than one
Very High: Persistent                100,000 ppm or 10%         occurrence per day     <0.55           10
Failures                     50 per thousand pieces               One occurrence
                                        50,000 ppm or 5%         every 3 to 4 days     >0.55           9
                                20 per thousand pieces         One occurrence per
                                       20,000 ppm or 2%                week            >0.78           8
High: Frequent Failures
                               10 per thousand pieces             One occurrence
                                       10,000 ppm or 1%            every month         >0.86           7
                              5 per thousand pieces               One occurrence
                                      5,000 ppm or 0.5%         every three months     >0.94           6
Moderate: Occasional            2 per thousand pieces             One occurrence
Failures                              2,000 ppm or 0.2%          every six months      >1.00           5
                               1 per thousand pieces           One occurrence per
                                      1,000 ppm or 0.1%                 year           >1.10           4
                             1 in 2,000 pieces                    One occurrence
Low: Relatively Few                     500 ppm or 0.05%         every 1 to 3 years    >1.20           3
Failures                     1 in 10,000 pieces                   One occurrence
                                       100 ppm or 0.01%          every 3 to 5 years    >1.30           2
                              1 in 100,000 pieces                One occurrence
Remote: Failure is Unlikel            10 ppm or 0.001%         greater than 5 years    >1.67           1
Note: Likely failure rates are based on internal occurences only, not frequency of defect escapes to
the customer
Note: Same table as PFMEA
SUGGESTED DESIGN FMEA DETECTION RANKINGS
 Detection                 Criteria: Likelihood of Detection by Design Control                Ranking
Almost      Design Control will not and/or can not detect a potential cause/mechanism and
Impossible  subsequent failure mode; or there is no Design Control.                             10
            Very remote chance the Design Control will detect a potential cause/mechanism
Very Remote and subsequent failure mode.                                                         9
            Remote chance the Design Control will detect a potential cause/mechanism and
Remote      subsequent failure mode.                                                             8
            Very low chance the Design Control will detect a potential cause/mechanism and
Very Low    subsequent failure mode                                                              7
            Low chance the Design Control will detect a potential cause/mechanism and
Low         subsequent failure mode                                                              6
            Moderate chance the Design Control will detect a potential cause/mechanism and
Moderate    subsequent failure mode                                                              5
Moderately Moderately high chance the Design Control will detect a potential
High        cause/mechanism and subsequent failure mode                                          4
            High chance the Design Control will detect a potential cause/mechanism and
High        subsequent failure mode                                                              3
            Very high chance the Design Control will detect a potential cause/mechanism and
Very High   subsequent failure mode                                                              2
            Design Control will almost certainly detect a potential cause/mechanism and
Certain     subsequent failure mode                                                              1
                                                                                        POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS (DESIGN FMEA)
                                                                                                                                                                                                                    Responsibility              Action Results
                                                                                                                                                                                  DETECT
                                                                                                                         OCCUR
                                                                                                                                                                                                   Recommended
                                                                              CLASS
                                                                                                                                                                                           RPN #
                                                                                           Potential Cause(s)/                   Current Design Controls      Current Design                                          & Target
                                                                        SEV
Item/Function   Potential Failure Mode Potential Effect(s) of Failure                                                                                                                               Action(s) and
                                                                                        Mechanism(s) of Failure(s)                     Prevention            Controls Detection                                      Completion
                                                                                                                                                                                                                                                             OCC
                                                                                                                                                                                                                                                                         RPN
                                                                                                                                                                                                                                                       SEV
                                                                                                                                                                                                                                                                   DET
                                                                                                                                                                                                   Action Results                     Actions Taken
                                                                                                                                                                                                                        Date
 A Functions No function -              Component: xxx(7)               7             A - xxxx                            5      1 - xxxxx (5)             1 - xxxxx (7)           7       245 1 - xxxxxx           xxxxxxx
             examples:     xxxxx        System: xxx(5)                                B - xxxxx                      C           2 - xxxx (7)              2 - xxxx (8)                        2 - xxxx             mm/dd/yy
             xxxxxx                     Adjacent System: xxx(5)                       - xxxxx                                                                                                  3 - xxx
                                        End User: NA                                                                                                                                           (6 x 4 x 4)
                                        Vehicle: xxx(6)
                                        Regulatory: NA
                Partial Function -      Component: xxx(7)               7             A - xxxx                            4      1 - xxxxx (6)             1 - xxxxx (7)           7       196 1 - xxxxxx           xxxxxxx
                examples:               System: xxx(5)                                B - xxxxx                                  2 - xxxx (4)              2 - xxxx (8)                        2 - xxx              mm/dd/yy
                                        Adjacent System: xxx(5)                       C - xxxxx                                                                                                (6 x 4 x 4)
                                        End User: NA
                                        Vehicle: xxx(6)
                                        Regulatory:
                Intermittent Function - Component: xxx(7)               7             A - xxxx                            4      xxxx                      1 - xxxxx (7)           7       196 1- xxxxxx            xxxxxxx
                examples:               System: xxx(5)                                B - xxxxx                                                            2 - xxxx (8)                        (7 x 4 x 3)          mm/dd/yy
                                        Adjacent System: xxx(5)                       C - xxxxx                                                            3 - xxxxxxx (8)
                                        End User: NA
                                        Vehicle: xxx(6)
                                        Regulatory: NA
                Loss of Function Over Component: xxx(6)                 6             xxxxxxxxxxx                         4      xxxxxxxx                  1 - xxxxx (7)           7       168 1- xxxxxx            xxxxxxx          xxxxxxx           6     4     3     72
                Time - examples:      System: xxx(5)                                                                                                       2 - xxxx (8)                        (6 x 4 x 3)          mm/dd/yy         mm/dd/yy
                                      Adjacent System: xxx(5)
                                      End User: (6)      Vehicle:
                                      xxx(6)    Regulatory: NA
                Unintended Function - Component: xxx(7)                 9     <S> xxxxxxxxxxx                             5      xxxx                      xxxxxxx                 2       90 1- xxxxxx             xxxxxxx          xxxxxxx           7     5     2     70
                examples:             System: xxx(5)                                                                                                                                          (7 x 5 x 2)           mm/dd/yy         mm/dd/yy
                                      Adjacent System: xxx(5)
                                      End User: NA
                                      Vehicle: xxx(6)
                                      Regulatory: (9)
 B Functions
 C Functions
A Components
 Functions…
B Components
 Functions…
   A Sub-
  Assembly
  Functions
   B Sub-
  Assembly
  Functions
   C Sub-
  Assembly
  Functions
                                                                                           POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS (DESIGN FMEA)
                                                                                                                                                                                                                              Responsibility               Action Results
                                                                                                                                                                                          DETECT
                                                                                                                            OCCUR
                                                                                                                                                                                                             Recommended
                                                                                CLASS
                                                                                                                                                                                                   RPN #
                                                                                             Potential Cause(s)/                    Current Design Controls        Current Design                                               & Target
                                                                          SEV
 Item/Function    Potential Failure Mode Potential Effect(s) of Failure                                                                                                                                       Action(s) and
                                                                                          Mechanism(s) of Failure(s)                      Prevention              Controls Detection                                           Completion
                                                                                                                                                                                                                                                                         OCC
                                                                                                                                                                                                                                                                                     RPN
                                                                                                                                                                                                                                                                               DET
                                                                                                                                                                                                                                                                   SEV
                                                                                                                                                                                                             Action Results                      Actions Taken
                                                                                                                                                                                                                                  Date
A. Illuminate a No function – Light       No light, customer              8             A - No electrical system             4      A - Spring contact and      A & B- Electrical and     2`       64      Design             Joey C           Completed 10/1/13   8     4     2     64
targeted, dark doesn’t work               dissatisfaction                               continuity                                  electrical design to        continuity checks in                       compartment to     8/4/13
area. Directed                                                                                                                      ensure continuity even if   process and final                          hold spare bulb
 light source.                                                                          B - Broken bulb                             not fully assembled         inspections.
                                                                                            C -Batteries inserted                   B - Add a replacement       C- Visual checks for
                                                                                        backward                                    bulb                        polarity marking and
                                                                                                                                    C - Clearly visible and     legibility in process and
                                                                                                                                    permanently marked          final.
                                                                                                                                    battery polarity on the     C - Artwork review and
                                                                                                                                    light                       approval for packaging
                                                                                                                                    C - Provide clear battery   instructions.
                                                                                                                                    insertion and polarity
                                                                                                                                    instructions on the
                                                                                                                                    package instructions
                 Partial Function – Lower Less light, customer            7             A. Bulb degredation                  5      A- Add a replacement        A - Electrical and         4       140     Design             Joey C           Completed 10/1/13   7     4     4     112
                 level light lumens       annoyance or dissatisfaction                  B- Battery degredation                      bulb                        continuity checks in                       compartment to     8/4/13
                                                                                                                                    B- Bulb selection for       process and final                          hold spare bulb
                                                                                                                                    maximum performance         inspections.
                                                                                                                                    from 66% of two AA          B- Design validation
                                                                                                                                    batteries (2.0V)            testing per LP457
                 Intermittent Light       Flashlight doesn't always       7             A - Misassembly by consumer          3      A & C. Design from          A - Electrical and         2       42      None
                                          work when turned on, or                       (not tightly screwed together)              aluminum with fine          continuity checks in
                                          stay on consistently.                                               B-                    machine threads to          process and final
                                          Customer annoyance or                         Intermittent electrical contact             improve fit, tolerance,     inspections.
                                          dissatisfaction.                              (bent spring, not enough                    and ease of assembly        C-Life test, abuse test
                                                                                        tension between                             with assured                and design validatiohn
                                                                                        spring/batter/bulb)                         B - spec spring per         testing per LP457
                                                                                                C - Loose fit in the                ASTM standard, or better
                                                                                        battery compartment allowing
                 Loss of Function Over    Battery deterioration (wear     6             battery
                                                                                        Nothingand
                                                                                                 cancomponent
                                                                                                      be done for battery    4      N                           Design validation          5       120     None
                 Time                     item), Bulb deterioration                     deterioration.                                                          testing per LP457,
                                          (wear item). Customer                         Bulbs are wear items and                                                including drop testing,
                                          annoyance.                                    require periodic replacement.                                           abuse testing and
                                                                                                                                                                vibration testing
                 Unintended Function – Customer injury or death           10 <S> This product is not designed for            1      Warn on packaging - Not None                          10       100     None
                 spark causing explosion around expolsive gases or               use in explosive atmospheres.                      for use in explosive
                                         vapors                                  Gaps in contact points can                         atmospheres
                                                                                 generate sparks. Design tight
                                                                                 fits and tolerances with spring
                                                                                 force appropriate to avoid air
                                                                                 gaps and sparks.
                                                                                 Bulbs self contained and would
                                                                                 not create external spark or
                                                                                 heat to ignite a gas.
B Functions No function -
            examples:     xxxxx
            xxxxxx
            Partial Function -
            examples:
            Intermittent Function -
            examples:
            Loss of Function Over
            Time - examples:
            Unintended Function -
            examples:
 C Sub-     No function -
Assembly    examples:     xxxxx
Functions   xxxxxx
            Partial Function -
            examples:
            Intermittent Function -
            examples:
            Loss of Function Over
            Time - examples:
            Unintended Function -
            examples:
Flashlight (MAG-LITE) - Design FMEA
What functions are supposed to be performed by the flashlight (features, characteristics)? What is it supposed to do? Regulat
Functions of the flashlight:
       1.    Illuminate dark areas
       2.    Emergency lighting
       3.    Focused lighting
       4.    Etc.
What are all component parts and subassemblies and their function? Think about mating parts and their function. What dysf
Functions of the components and subassemblies:
            1.   Battery electrical contacts
            2.   Battery containment
            3.   Waterproof sealing / housing
            4.   Bulb to electrical contacts to battery to on/off switch
            5.   End cap to seal and secure batteries and contact
            6.   Etc.
is it supposed to do? Regulatory requirements?
and their function. What dysfunctions and unmarketability can occur? Don’t forget packaging and labeling.