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Global Purchasing and Supply Chain PFMEA
MBB
Jorge
López
Morales
Supplier PFMEA Workshop
Agenda:
Introduc:ons
(Name,
your
role,
how
much
hands-‐on
knowledge/prac:cal
experience
with
PFMEA?)
Safety
Protocol
and
logis:cs
(evacuate,
take
shelter,
restrooms,
etc.)
Supplier
informa:on
–
tell
us
about
your
business
PFMEA
Discussion
• Why
focus
on
PFMEA?
(benefits
to
supplier
and
customer)
• PFMEA
basics
• RPN
and
risk
assessment
methods
• Risk
reduc:on
and
linkages
Break
(5
min.)
Floor
Walk
Process
Review
Break
(15
min.)
Workshop
• Team
reviews
the
process
step
to
be
discussed
in
the
PFMEA
• Lunch
(working)
• PFMEA
line
item
development
• Lessons
learned
and
wrap-‐up
• De-‐brief
Global Purchasing and Supply Chain PFMEA
MBB
Jorge
López
Morales
Este
Material
ha
sido
preparado
para
llevar
a
cabo
un
Taller
de
PFMEA
(AIAG
4ta
edición)
con
duración
aproximada
de
5-‐6
hrs.
Con:ene
la
información
esencial
y
concreta
para
exponer
las
bases
y
directrices
de
un
correcto
PFMEA.
Este
material
debe
ser
usado
en
conjunto
con
el
manual
de
AIAG
y
el
formato
Electronico
de
Excel
de
PFMEA.
El
Material
del
facilitador
esta
redactado
en
Ingles
para
respetar
el
idioma
original
del
Manual
AIAG.
Cualquier
mejora
o
modificación
favor
de
informar
a
PFMEA
MBB
Jorge
López
Morales
Jorge.lopezmorales@gm.com
Global Purchasing and Supply Chain PFMEA
MBB
Jorge
López
Morales
Why the focus on PFMEA?
• Inves:ga:ng
Field
Ac:ons
(including
recalls)
we
found
three
general
areas
of
cause:
Global Purchasing and Supply Chain PFMEA
MBB
Jorge
López
Morales
So
what
is
PFMEA?
Process
FMEA
is
a
systema>c
approach
to:
• Focus
specifically
on
the
sta:on
by
sta:on
work
content
and
requirements
to
make
a
“good”
part,
and
also
to
document
the
en:re
process
(process
flow)
• Not
a
process
to
find
fault
with
the
good
work
completed
to
date
Global Purchasing and Supply Chain PFMEA
MBB
Jorge
López
Morales
A
Successful
PFMEA
Ac:vity…
• The cross-functional team has a “good discussion” about the process
requirements and potential risks
Global Purchasing and Supply Chain PFMEA
MBB
Jorge
López
Morales
PFMEA
simply
asks
the
ques:on:
Global Purchasing and Supply Chain PFMEA
MBB
Jorge
López
Morales
Types of Automo?ve FMEAs:
System FMEA – is intended to transform customer needs into a description of system performance. It
helps define parameters and system configuration.
Design FMEA – is used to analyze the design requirements and to correctly identify and to audit
the adequacy of the specifications. It also helps to define a product that, when built to the
print specification, will meet the design requirements
• Focuses on potential failure modes of products caused by design deficiencies
• Focuses on parts that can be prototyped and tested or modeled before high volume production of
the product is launched
• Process FMEA – is used to analyze manufacturing and assembly processes.
• Focuses on potential product failure modes caused by manufacturing or assembly process
deficiencies.
• PFMEA can involve fabrication, transactions or services
• Machinery FMEA – is used to analyze specialty machinery. Focuses on designs that improve the
reliability and maintainability of the machinery for long term usage
• Considers preventive maintenance as a control to ensure reliability.
Global Purchasing and Supply Chain PFMEA
MBB
Jorge
López
Morales
A PFMEA should be created or reviewed
when there is…
• New
Technology
–
design
or
process
• Change
to
design
or
process
• New
Applica:on
• Quality
Issue
(internal
or
external)
• Safety
concern
• New
informa:on
from
a
capability
study
or
run-‐at-‐rate
• New
quality
data
(warranty,
field
ac:ons,
customer
feedback)
• Cri:cal
personnel
or
line
rate
change
• Risk
reduc:on
ac:vity
(as
related
to
QSB+)
• Any
change
that
impacts
the
process
Global Purchasing and Supply Chain PFMEA
MBB
Jorge
López
Morales
What are some of the tools used
during PFMEA ac?vi?es?
• Capability
study
or
run-‐at-‐rate
results
• DFMEA
(severity
and
requirements)
• SOR,
drawings
and
design
records
(severity
and
requirements)
• Process
Flow
Chart
or
Diagram
• Historical
performance
data
(occurrence)
• Process
Control
Plan
• Work
Instruc:ons
• QSB+
risk
reduc:on
guidelines
Global Purchasing and Supply Chain PFMEA
MBB
Jorge
López
Morales
We start with these PFMEA Assumptions
according AIAG Manual
.
• Does
the
RPN
‘tell’
the
whole
story
rela>ve
to
risk?
• Ex:
7-‐3-‐4=>84
versus
3-‐4-‐7=>84,
same
RPN
but
‘tells’
a
different
story
• Should
we
look
beyond
strictly
RPN
to
understand
risk
beTer?
Global Purchasing and Supply Chain PFMEA
MBB
Jorge
López
Morales
Why
should
we
change?
Tradi:onal
Risk
Assessment
Method:
Iden:fy
RPNs
above
a
threshold
number
(such
as
100)
and
perform
risk
reduc:on.
RPNs
under
the
threshold
typically
did
not
require
addi:onal
ac:on.
This
approach
tended
to
drive
the
wrong
behavior.
Improved
Method,
but
s:ll
strictly
RPN
focused:
From
Page
103
of
AIAG
4th
Edi:on
FMEA
Manual:
The
use
of
an
RPN
threshold
is
NOT
a
recommended
prac7ce
for
determining
the
need
for
ac7ons.
Applying
thresholds
assumes
that
RPNs
are
a
measure
of
rela:ve
risk
(which
they
oren
are
not)
and
that
con:nuous
improvement
is
not
required
(which
it
oren
is).
The
industry
moved
toward
a
pareto-‐style
approach
(top
five
or
ten
highest
RPNs).
So,
if
we
applied
an
arbitrary
threshold
of
Severity
Occurrence
Detec:on
RPN
100
or
used
the
guideline
of
working
on
the
highest
RPN
first,
which
line
item
would
we
be
required
to
take
ac:on
on?
Line
Item
A
9
2
5
90
B
7
4
4
112
Global Purchasing and Supply Chain PFMEA
MBB
Jorge
López
Morales
Risk Limi?ng Method
Global Purchasing and Supply Chain PFMEA
MBB
Jorge
López
Morales
Risk Limi?ng Method
Priority Level
10 3 1 1 1 1 1 1 1 1 1 10 3 2 1 1 1 1 1 1 1 1
Priority Level
9 3 1 1 1 1 1 1 1 1 1 9 3 2 1 1 1 1 1 1 1 1
Occurrence
8 3 2 1 1 1 1 1 1 1 1 8 3 2 2 2 2 2 1 1 1 1
Detection Zone
(Sev vs. Det)
3 2 2 3
Detection
7 3 2 2 2 1 1 1 1 1 1 7 3 3 3 3 2 2 2 2 1 1
6 3 2 2 2 1 1 1 1 1 1 6 3 3 3 3 3 3 2 2 1 1 2 1 2 3
5 3 3 2 2 2 2 1 1 1 1 5 3 3 3 3 3 3 3 3 2 2
4 3 3 3 3 2 2 1 1 1 1 4 3 3 3 3 3 3 3 3 2 2 1 1 1 2
3 3 3 3 3 3 3 2 2 1 1 3 3 3 3 3 3 3 3 3 3 3
2 3 3 3 3 3 3 2 2 1 1 2 3 3 3 3 3 3 3 3 3 3 1 2 3
1 3 3 3 3 3 3 3 3 3 3 1 3 3 3 3 3 3 3 3 3 3 Occurence Zone
1 2 3 4 5 6 7 8 9 10 1 2 3 4 5 6 7 8 9 10 (Sev vs. Occ)
Severity Severity
Global Purchasing and Supply Chain PFMEA
MBB
Jorge
López
Morales
What are the methods for Risk Reduc?on?
• PFMEA
Review
Process:
Cross-‐func:onal
teams
should
review
PFMEA’s
periodically
(con:nuous
improvement).
This
is
referenced
in
QSB+
RR1.
• PFMEA
Reac>ve
Risk
Reduc>on
Process:
Risk
Reduc:on
through
review
of
quality
issues
(customer
concerns,
internal
performance).
This
is
referenced
in
QSB+
RR3.
• Proac>ve
Reverse
PFMEA
Process:
Reverse
PFMEA
is
an
in-‐sta:on
review
of
all
failure
modes
included
in
PFMEA
to
verify
that
all
failure
modes
have
proper
controls
(Preven:on
controls
or
Detec:on
controls)
and
that
they
are
working
properly.
This
is
referenced
in
QSB+
RR4
–
There
is
a
Reverse
PFMEA
process
in
place
to
iden>fy
new
poten>al
failure
modes
on
shop
floor.
Global Purchasing and Supply Chain PFMEA
MBB
Jorge
López
Morales
Primary Linkages of PFMEA
(PFMEA should not be a stand alone document)
DFMEA/SFMEA
• Identify process sensitive design/system
attributes
• High severity items need consistent
identification in the process and PFMEA
• Safety & Critical Items
Master
/
Similar
part
PFMEA
Process Flow
• Also called a template PFMEA
• List of operations or process function • Family of parts, same commodity
• Sequence of build, ordered operations • Safety & Critical Items
• Safety & Critical Items PFMEA
• Requirements
• Effects of Failure (internal and external)
• Appropriate occurrence ranking
MFMEA
• Current detection controls
• Machine/Machinery FMEA
Control
Plan
• Recommended actions for risk reduction
• Specialized or complex equipment
• Safety & Critical Items
• List of operations or process function • Safety & Critical Items
• Measurement methods and frequency
• Safety & Critical Items Work
Instruc>ons
/
SOP
• Detail of Operations
• Safety & Critical Items
Global Purchasing and Supply Chain PFMEA
MBB
Jorge
López
Morales
Any Ques?ons or Comments?
Global Purchasing and Supply Chain PFMEA
MBB
Jorge
López
Morales
De-‐brief -‐ Feedback and End of Day Discussions
At
the
end
of
the
workshop
there
will
be
a
15
to
30
min
wrap
up.
As
with
a
strong
PFMEA
there
is
con:nuous
improvement
and
it
will
be
the
same
for
this
workshop.
These
ac:on
items
are
taken
by
the
facilitator
and
captured
on
an
Ac:on
Item
List
to
be
completed
prior
to
the
next
workshop
and
be
part
of
the
presenta:on.
Topics:
What
worked
well:
What
didn’t
work
well:
Topics
to
add
detail,
and
or
clarity:
Topics
to
reduce/simplify:
Visual
aid’s
and/or
support
documenta:on
needed:
5
Take-‐Aways
from
workshop:
Involve
a
cross
func:onal
team
with
all
PFMEA
ac:vi:es
(good
discussion)
Iden:fy
the
requirements
of
each
process
step
Iden:fy
the
effects
of
the
failure
internally
and
externally
(GM
and
customer)
Consistency
in
ranking
(use
objec:ve,
AIAG
based
S-‐O-‐D
ranking
charts)
When
a
line
item
is
completed,
does
it
read
as
a
‘story’
and
make
sense
Global Purchasing and Supply Chain PFMEA
MBB
Jorge
López
Morales
Back-‐up material
Global Purchasing and Supply Chain PFMEA
MBB
Jorge
López
Morales
Basic FMEA Structure
Global Purchasing and Supply Chain PFMEA
MBB
Jorge
López
Morales
Step
1:
Developing the PFMEA
Display
the
Process
Flow
Diagram
and
use
for
detailing
the
PFMEA
Process
Step/
Func:on,
Requirement,
Poten:al
Failure
Mode
And
Poten:al
Effect(s)
of
Failure
columns.
Insure
the
same
terms
and
descrip:ons
are
used
when
popula:ng
the
PFMEA.
Completely
fill
in
all
columns
before
moving
to
Step
2.
Listed
below
are
criteria
for
each
of
the
columns
to
add
clarifica:on
as
these
are
filled
in.
Process
Step/Func:on:
This
is
the
Opera:on
Number
and
Func:on
that
occurs
at
that
point
in
the
process.
Be
sure
to
copy
verba:m
what
is
on
the
Process
Flow
Diagram.
Requirements
Detail
in
concise
terms
the
requirements
at
the
respec:ve
opera:on.
Include
deliverables,
product
features,
etc.,
that
are
created
at
that
Process
Step.
Insure
PFMEA
is
consistent
with
process
flow
diagram
Global Purchasing and Supply Chain PFMEA
MBB
Jorge
López
Morales
Developing the PFMEA -‐ Con?nued
Poten:al
Failure
Modes
U:lize
historical
data
reviewed
to
access
error
proofing
requirements
as
well
as
severity,
occurrence,
and
detec:on
rankings
Conduct
a
risk
analysis
to
include
only
steps
that
would
have
a
nega:ve
impact
on
the
quality
of
the
product.
Assume
a
failure
mode
could,
but
not
necessarily
occur.
Be
specific
with
terms
used
to
describe.
Undersize
hole
rather
than
out
of
specifica:on.
Poten:al
Effect(s)
of
Failure
• Defined
as
the
effects
of
the
failure
mode
as
perceived
by
the
customer(s).
Described
as
what
the
customer
might
no:ce
or
experience.
Customer(s)
may
be
the
next
opera:on,
opera:ons,
loca:on,
or
end
user.
• Insure
if
the
failure
mode
is
safety
related,
results
in
non-‐compliance,
or
significant
dissa:sfier,
it
must
be
clearly
defined
in
the
PFMEA.
• Ques:ons
to
determine
the
Poten:al
Effects:
• Does
it
prevent
downstream
processing
or
nega:vely
impact
a
downstream
customer.
• Can
it
harm
operators,
or
damage
equipment
• If
it
can,
review
and
access
the
impact
and
document
in
the
PFMEA
• Addi:onal
Analysis
• Impact
on
the
End
User
• Impact
of
detec:ng
prior
to
the
End
User
Global Purchasing and Supply Chain PFMEA
MBB
Jorge
López
Morales
Step
2:
Start
with
the
first
Process
Step
and
work
horizontally
across
all
columns
to
and
including
comple:on
of
the
RPN
number
for
every
Poten:al
Effects
of
Failure.
Insure
all
Poten:al
Causes
of
the
Failure
are
detailed.
Listed
below
are
each
heading
with
descrip:ons,
and
challenge
ques:ons
we
need
to
insure
against.
Severity
Severity
is
the
value
associated
with
the
most
serious
effect
for
a
given
failure
mode.
Team
required
to
agree
on
value.
Use
AIAG
PFMEA
Chap
IV
Rankings
combined
with
GM
GQP-‐012a
to
determine
RPN
values.
Classifica>on
Use
this
column
to
highlight
high
priority
failure
modes
that
may
require
Engineering
follow-‐up.
Also
for
special
process
and/or
product
requirements
per
the
Key
Characteris:cs
Designa:on,
(KCDS).
Global Purchasing and Supply Chain PFMEA
MBB
Jorge
López
Morales
Step 2: Developing the PFMEA -‐ Con?nued
Poten:al
Cause(s)
of
Failure
Defined
as
how
the
failure
can
occur.
Specify
it
in
such
a
manner
as
can
be
controlled
and/or
corrected.
Be
specific
in
the
terms
used
that
can
be
corrected
or
controlled.
Terms
like
debris,
flash,
worn
tooling,
etc.
Note
there
are
usually
mul:ple
causes
for
each
failure
mode
and
each
one
creates
a
separate
row
of
the
PFMEA.
Occurrence
The
rank
associated
with
the
likelihood
that
a
specific
Poten:al
Cause
will
occur
during
this
step
of
the
process.
Refer
to
AIAG
PFMEA
Chap
IV
for
Occurrence
Rankings.
Refer
to
exis:ng
produc:on
data,
team
experience,
maintenance
records
for
reference.
Controls
Preven:on
Detail
specific
controls,
and
process
designs
that
would
shut
down
the
machine,
not
allow
to
transfer,
automa:c
lock
out,
operator
engagement,
etc.
that
will
prevent
the
Failure
Mode
or
Cause.
Preven:on
is
preferred
over
detec:on
to
reduce
the
overall
risk.
Global Purchasing and Supply Chain PFMEA
MBB
Jorge
López
Morales
Developing the PFMEA -‐ Con?nued
Controls
Detec:on
Methods
to
be
or
that
are
in
use
to
detect
the
failure
mode
and/or
cause.
Specify
the
controls
used
to
detect
the
failure.
Insure
that
the
loca:on
of
the
detec:on
is
detailed
as
it
may
be
located
downstream
from
the
opera:on
that
created
it.
Detail
fixtures,
sensors,
process
parameters,
etc.,
to
flag
a
non-‐conformance.
Detec:on
The
rank
associated
with
the
probability
that
the
current
process
control
will
detect
the
failure
mode.
RPN
The
Risk
Priority
Number
is
the
product
of
the
Severity
(S),
Occurrence
(O),
and
Detec:on
(D).
It
represents
an
es:mate
of
the
overall
risk
that
a
specific
cause
presents
to
the
process.
To
calculate
the
RPN:
Highest
Severity
x
Occurrence
x
Best/Lowest
Detec:on
=
RPN
For
RPN
Reduc:on,
work
the
highest
RPN
items
as
first
priority.
Global Purchasing and Supply Chain PFMEA
MBB
Jorge
López
Morales
Developing the PFMEA -‐ Con?nued
Recommended
Ac:on
Preventa:ve
ac:ons
to
reduce
the
occurrence
are
preferable
to
detec:on
ac:ons.
Process
design
error
proofing
integrated
into
manufacturing
process
rather
than
quality
checks,
random
or
scheduled.
The
purpose
of
any
recommended
ac:on
is
to
reduce
the
rankings.
The
first
priority
is
severity,
second
is
occurrence,
the
third
is
detec:on.
Reducing
Severity
Ranking
comes
only
from
design
and/or
process
revisions.
The
most
effec:ve
and
efficient
method
is
to
incorporate
design
and/or
process
revisions
as
early
in
the
part
or
process
design
as
possible.
Team
review
and
consensus
is
very
important
at
this
stage
of
severity
review
and
reduc:on.
Reducing
Occurrence
Ranking
can
be
accomplished
by
controlling
or
removing
one
or
more
of
the
causes.
This
can
be
done
thorough
product
and
and/or
process
design
revisions.
Reducing
Detec:on
Ranking
is
most
effec:ve
through
error
proofing
or
mistake
proofing.
Either
a
new
or
redesign
of
the
exis:ng
error
proofing
may
be
required
to
reduce
this
ranking
effec:vely.
Not
that
a
revision
in
the
inspec:on
frequency
is
not
an
effec:ve
method
and
should
only
be
used
as
a
temporary
measure.
Global Purchasing and Supply Chain PFMEA
MBB
Jorge
López
Morales
Responsibility & Target Comple?on Date
The individual and organiza?on/dept. assigned as responsible for comple?ng each recommended ac?on
along with the target date. The organiza?on/dept. team leader is responsible for insuring target dates are
met, and/or escala?on as required to insure appropriate support is in place. The team leader is responsible
that the ac?on has been appropriately completed.
Ac?ons Taken & Comple?on Date
Iden?fy the results of any ac?ons that have been completed. Insure a brief clear descrip?on and
comple?on date is entered.
Global Purchasing and Supply Chain PFMEA
MBB
Jorge
López
Morales
Developing the PFMEA -‐ Con?nued
Ac:on
Results:
PFMEA
is
a
live
document.
Ongoing
ac:ons
to
reduce
RPN
ranking
are
required
as
part
of
the
con:nuous
improvement
process.
Ac:ons
iden:fied
and
completed
drive
an
update
to
the
RPN
ranking
based
on
the
completed
ac:ons
in
the
far
right
columns
under
Ac:on
Results.
As
the
ac:ons
are
completed
update
the
appropriate
ranking
noted
below.
Severity
–
Revised
Enter
in
the
revised
Severity
arer
the
ac:on
taken
has
been
completed.
Occurrence
–
Revised
Enter
in
the
revised
Occurrence
Ranking
arer
the
ac:on
taken
has
been
completed.
Detec:on
–
Revised
Enter
in
the
revised
Detec:on
Ranking
arer
the
ac:on
taken
has
been
completed.
RPN
–
Revised
Calculate
the
revised
RPN
Ranking
arer
all
the
affected
SEV,
DET,
OCC
have
been
revised
and
enter
in
the
new
RPN
Ranking.
Global Purchasing and Supply Chain PFMEA
MBB
Jorge
López
Morales
PFMEA Workshop
Required
-‐
Workshop
Prepara:on
to
be
Completed
a
Minimum
of
Two
Weeks
in
Advance
of
the
Scheduled
Workshop
• Cross
func:onal
team
members
iden:fied,
(
SQE,
DRE,
Supplier’s
ME,
Maintenance,
Suppliers
QE,
Supplier
Op’s,
etc)
• Schedule
and
loca:on
agreed
• Workforce
informed
as
par:cipants
will
visit
shop
floor
• Facili:es
&
required
materials
available
for
presenta:on
and
par:cipants
• Part
drawings
• Copies
of
exis:ng
PFMEA,
DFMEA,
Process
Flow,
&
Control
Plans
• Problems,
Lessons
Learned,
PPM
Metrics
over
past
12
months
• FTQ,
&
Warranty
informa:on
• White
board
w/
prin:ng
capability
or
flip
chart
to
capture
ac:vi:es
• Casual
dress
code
• Supplier
communica:on
to
GM
team
of
any
recent
programs/workshops
conducted
that
were
similar
and
of
any
workforce
problems
• Electronic
Template
used
to
create/revise
PFMEA
to
be
used
with
Supplier
making
recommended
changes
to
their
PFMEA
• Reference
for
PFMEA
Columns
and
their
rela:onships
Global Purchasing and Supply Chain PFMEA
MBB
Jorge
López
Morales
Any
Ques:ons,
contact
to:
Global Purchasing and Supply Chain PFMEA MBB Jorge López Morales