Label Error Proofing PFMEA Process Analysis

Label Error Proofing PFMEA
Process
Function/
Requirement
Remove all old
labels from
container/pallet
Generate
component label
Potential Failure Mode
Potential
Effect(s) Of
Failure
S
E
V
C
l
a
s
s
Potential Cause(s) /
Mechanism(s) of
Failure
Containers/pallets are not free

of old labels (external AIAG
labels) before reaching the
mfg. floor
Procedure does not assign

responsibility for removing old
external AIAG labels before
container/pallet reaches mfg.
floor
Unable to remove old external
AIAG labels
Containers/pallets are not free

of old labels (internal labels)
before being re-introduced to
the process
Procedure does not assign

responsibility for removing old
internal labels before
container/pallet is re-introduced
to process
Unable to remove old internal
labels
Component labels are not

available to the operator
Equipment downtime
(no back-up system)
Component label is not legible

or scannable
Component label does not

contain correct information or
does not meet all QS9000
procedures & engineering
requirements
O
C
C
U
R
Current Process
Controls
D
E
T
E
C
T
R
P
N
Responsibility &
Target Date
Completion
Actions Taken
S
E
V
O
C
C
U
R
D
E
T
E
C
T
Lack of trained, back-up

personnel to generate
component labels
Component label
contamination (e.g. dirt, grease,
torn, writing through barcode)
Equipment problems (e.g.
printer misfeed, out of ink,
misaligned)
Database information is
incorrect
Manual data entry to generate

component label
Apply component
label to component
part
Component label does not

match component
Written work procedure for

changeover is not available in
the work cell
Similar components produced
on the same line
Component labels available for
more than one component
number in work cell
Page 1 of 9
Revision 1 02/04/00
R
P
N
Process
Function/
Requirement
Potential
Effect(s) Of
Failure
S
E
V
C
l
a
s
s
Mechanism(s) of
Failure
O
C
C
U
R
Current Process
Controls
D
E
T
E
C
T
R
P
N
Responsibility &
Target Date
Completion
Actions Taken
S
E
V
O
C
C
U
R
D
E
T
E
C
T
R
P
N
S
E
V
O
C
C
U
R
D
E
T
E
C
T
R
P
N
No error proofing (manual or

mechanical) to verify
component label = component
Lack of visual aids in written
work procedures
Non-running component labels
left in work cell at changeover
mechanical) to detect presence
of component label
Expired shelf life
Component label not applied

Component label falls off
Improperly applied
adhesive from vendor
Component label causes
degradation to component
Generate work-inprocess (WIP) tag
Contamination (e.g. ink jet on

contacts)
misaligned)
Component label placed in
wrong location on component
part
Equipment downtime
(no back-up system)
personnel to generate WIP tags
WIP tag contamination (e.g.
dirt, grease, torn, writing
through barcode)
misaligned)
Empty containers tagged
before WIP is put into container
WIP tags are not available to

the operator
WIP tag is not legible or

scannable
Attach WIP tag to

container
WIP tag does not match WIP in

the container
Pre-printed WIP tags
Process
Function/
Requirement
Page 2 of 9
Potential
Effect(s) Of
Failure
S
E
V
C
l
a
s
s
Mechanism(s) of
Failure
O
C
C
U
R
Current Process
Controls
D
E
T
E
C
T
R
P
N
Responsibility &
Target Date
Completion
Actions Taken
Revision 1 02/04/00
WIP tag not physically attached

to container
Old WIP tags left on container
Non-running WIP tags left in
work cell at changeover
Generate part
identification label
Part identification labels are

not available to the operator
Part identification label is not

legible or scannable
Part identification label does

not contain correct information
or does not meet all QS9000
procedures & engineering
requirements
Equipment downtime
(no back-up system)
personnel to generate part
identification labels
Part identification label
misaligned)
incorrect

part identification label
Apply part
identification label
to part
Part identification label does

not match part

changeover not available in
work cell
Similar parts/numbers
produced on the same line
Part identification labels are not
printed on demand (preprinted)
Part identification labels for
more than 1 part number
available in the work cell
If part identification labels are
pre-printed, they are not
controlled or secured
Page 3 of 9
Revision 1 02/04/00
Process
Function/
Requirement
Potential
Effect(s) Of
Failure
S
E
V
C
l
a
s
s
Mechanism(s) of
Failure
O
C
C
U
R
Current Process
Controls
D
E
T
E
C
T
R
P
N
Responsibility &
Target Date
Completion
Actions Taken
S
E
V
O
C
C
U
R
D
E
T
E
C
T

mechanical) to verify part
identification label = part
Non-running part identification
labels left in work cell at
changeover
Lack of visual aids in written
work procedures
Part identification label falls off

mechanical) to detect color
Expired shelf life
Improperly applied adhesive
from vendor
Part identification label causes

degradation to part
Part identification label not

applied properly to the part
Contamination (e.g. ink jet on
contacts)
misaligned)
Part identification label placed
in wrong location on part
No part identification label

applied
Generate internal
finished goods
label
Internal finished goods labels

are not available to the
operator
Internal finished goods label is

not legible or scannable
Page 4 of 9

mechanical) to detect presence
of part identification label
Missing insert (Stamped /
Molded)
Equipment downtime
(no back-up system)
personnel to generate internal
finished goods labels
misaligned)
Handwritten internal finished
goods labels
Revision 1 02/04/00
R
P
N
Process
Function/
Requirement
Potential
Effect(s) Of
Failure
S
E
V
C
l
a
s
s
Mechanism(s) of
Failure
O
C
C
U
R
Current Process
Controls
D
E
T
E
C
T
R
P
N
Responsibility &
Target Date
Completion
Actions Taken
S
E
V
O
C
C
U
R
D
E
T
E
C
T
Internal finished goods label

internal label
incorrect
Apply internal
finished goods
label to container
Internal finished goods label on

container does not match the
parts in the container

are not printed on demand
(pre-printed)
If internal finished goods labels
are pre-printed, they are not
controlled or secured
for more than 1 part number
the work cell
reintroducing partials is not
reintroducing re-work is not
Containers are pre-labeled
before 1st part goes in container
Unused internal finished goods
labels from previous run are not
properly stored or destroyed at
changeover
Similar parts packed out close
to each other
mechanical) to ensure that
internal finished goods label =
part
Poor workplace organization
(e.g. not a designated area for
internal finished goods labels)
Page 5 of 9
Revision 1 02/04/00
R
P
N
Process
Function/
Requirement
Generate AIAG B10 label
AIAG B-10 label does not meet

GM label standards (GM 1724,
GM-1724A-C, GM 1738 and
AIAG B-10 guidelines)
AIAG B-10 labels are not

available to the operator

legible or scannable
Potential
Effect(s) Of
Failure
S
E
V
C
l
a
s
s
Mechanism(s) of
Failure
O
C
C
U
R
Current Process
Controls
D
E
T
E
C
T
R
P
N
Responsibility &
Target Date
Completion
Actions Taken
S
E
V
O
C
C
U
R
D
E
T
E
C
T

mechanical) to detect similar
part colors
Document control doesn't
provide the latest information
for the label (e.g. revision level)
Not using current AIAG B-10
label format or adhering to size
and color standards
Equipment downtime
(no back-up system)
personnel to generate AIAG B10 labels
Handwritten AIAG B-10 labels
AIAG B-10 label contamination
(e.g. dirt, grease, torn, writing
through barcode)
misaligned)
incorrect
Apply AIAG B-10

to container
AIAG B-10 label on container

does not match the parts in the
container
Manual data entry into the

computer to generate AIAG B10 label
printed on demand (preprinted)
If AIAG B-10 labels are preprinted, they not controlled or
secured
More than 1 set of AIAG B-10
labels available in work cell
work cell
reintroducing partials is not
Page 6 of 9
Revision 1 02/04/00
R
P
N
Process
Function/
Requirement
Potential
Effect(s) Of
Failure
S
E
V
C
l
a
s
s
Mechanism(s) of
Failure
O
C
C
U
R
Current Process
Controls
D
E
T
E
C
T
R
P
N
Responsibility &
Target Date
Completion
Actions Taken
S
E
V
O
C
C
U
R
D
E
T
E
C
T

reintroducing re-work is not
Containers are pre-labeled
before 1st part goes in container
Unused AIAG B-10 labels from
previous run are not properly
stored or destroyed at
changeover
Similar parts packed out close
to each other
internal finished goods label =
AIAG B-10 label
depopulated AIAG B-10 label =
AIAG B-10 label
AIAG B-10 label = parts in
container
mechanical) to detect similar
colors
Poor workplace organization
(e.g. not a designated area for
AIAG B-10 labels)
Repacking due to Containment
Level 1 or Level 2
Repacking due to lack of
returnable containers
Repacking bulk to standard
pack
Old AIAG B-10 labels left on
container
Internal finished goods label is
wrong
Page 7 of 9
Revision 1 02/04/00
R
P
N
Process
Function/
Requirement
Material handling code and

reference labels are not legible
or scannable
Apply material
handling code and
reference label to
refresh AIAG B-10
label

reference label doesn't match
assembly plant requirements
Lack of traceability to
shift/line/operator/press
No material handling code and

reference label applied
Page 8 of 9
Potential
Effect(s) Of
Failure
S
E
V
C
l
a
s
s
Mechanism(s) of
Failure
O
C
C
U
R
Current Process
Controls
D
E
T
E
C
T
R
P
N
Responsibility &
Target Date
Completion
Actions Taken
S
E
V
O
C
C
U
R
D
E
T
E
C
T

personnel to generate material
handling code and reference
labels
reference labels contamination
(e.g. dirt, grease, torn, writing
through barcode)
reference labels are not printed
on demand (pre-printed)
mechanical) to ensure the
material handling code and
reference label matches the
AIAG B-10 shipping label
More than one material
labels for different plants
available at the same time
Workplace organization
prevents pre-staging shipments
reference label covers up
existing traceability
Manual entry into the
traceability log
mechanical) to ensure the
presence of the material
label
Revision 1 02/04/00
R
P
N
Tier 2 Supplier
Finished part
Tier 1 Supplier
Component and other
components = finished
part
General Motors
Component added to other
components = car
Tier 2 supplier's finished part becomes a component for tier 1 supplier.

Tier 1 supplier's finished part becomes a component for the GM Assembly Center.
Component label identifies components used to assemble final part.

Part identification label identifies the finished part shipped to your customer.
Work-In-Process tag identifies the manufacturing stages and typically travels with the container.
Internal finished goods label identifies finished goods with supplier specific information.
AIAG B-10 label identifies the ship-to Assembly Center's specific destination information
Page 9 of 9
Revision 1 02/04/00

Label Error Proofing PFMEA Process Analysis

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Label Error Proofing PFMEA Process Analysis

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Label Error Proofing PFMEA

Potential Failure Mode

Containers/pallets are not free

Procedure does not assign

Containers/pallets are not free

Procedure does not assign

Component labels are not

Component label is not legible

Component label does not

Lack of trained, back-up

Manual data entry to generate

Component label does not

Written work procedure for