Process_Failure_modes_and_effects_analysis

Report
PROCESS FAILURE
MODES AND EFFECTS
ANALYSIS
2013
BASIC PHILOSOPHY
 Risk based thinking is not
industry dependent!
 Airline (1,895 air traffic control
errors in 2012)
 Device (48 recalls in 2012)
 Pharma (45 recalls in 2012)
 To control risk, you need to know
where it exists
 Dynamic tool = control
 Static tool = waste of time
 Brainstorm, the more brains the
better
 You can never eliminate all risk
STEPS
1.
Map all ACTUAL steps of your process
a) Best practice: Brainstorm with the actual hands on people
b) Pitfalls: Don’t just go off of SOP steps, may loose detail
Item /
Function
Potential
Potential Potential S Cause(s)/
Failure Effect(s) of e Mechanis
Mode
Failure v m(s) of
Failure
O Current
D
Current
c Design
e
Design
c Controls
t
Controls
u Preventio
e
Detection
r
n
c
Action Results
Responsi
O D
R. Recommen bility &
S c e R.
P.
ded
Target ActionsTa
e c t P.
N. Action(s) Completio
ken
v u e N.
n Date
r c
What are the steps in the process?
EXAMPLE: EO CLINICAL BATCH RELEASE PROCESS
Item /
Function
Potential
Potential
Effect(s) of
Failure Mode
Failure
Compromise
integrity of
Unit
primary
unsuitable for
packaging
use
(pouches,
trays)
Prep for
sterilization by
stacking them
directly into the
sterilizer or
containing
them in a
basket in the EO penetration
sterilizer
variance due to Inconsistent
loading
SAL
configuration
S
e
v
1
3
Potential
Cause(s)/
Mechanism(
s) of Failure
Stuff too
many units
into basket
or sterilizer
Stuff too
many units
into
basket/cham
ber and/or
stacking of
full baskets
in chamber
O
c
c
u
r
3
2
Current
Design
Controls
Prevention
Current
Design
Controls
Detection
Sponsor
could double
pouch or Analyst and
sterilize in
Sponsor
secondary
visual
packaging or inspection of
use
units
additional
sterilizers
EO sterilizer
qualification
PQ
incorporates PCDs placed
a uniformity throughout
verification chamber,
by Bis
then BI
throughout tested for
fully loaded sterility to
chamber with
verify
dunnage.
Chamber
size is small.
D
e
t
e
c
R.
P.
N.
9
27
1
6
STEPS
2.
List all things that could go wrong with the step
a) Best practice: Put it all down, even if crazy! Include human factors.
b) Pitfalls: Don’t avoid putting it down because of low risk
Item /
Function
Potential
Potential Potential S Cause(s)/
Failure Effect(s) of e Mechanis
Mode
Failure v m(s) of
Failure
O Current
D
Current
c Design
e
Design
c Controls
t
Controls
u Preventio
e
Detection
r
n
c
Action Results
Responsi
O D
R. Recommen bility &
S c e R.
P.
ded
Target ActionsTa
e c t P.
N. Action(s) Completio
ken
v u e N.
n Date
r c
What could go wrong with that step?
What environmental or human factors could
contribute (stress, flow of work, concentration)?
EXAMPLE: EO CLINICAL BATCH RELEASE PROCESS
Item /
Function
Potential
Potential
Effect(s) of
Failure Mode
Failure
Compromise
integrity of
Unit
primary
unsuitable for
packaging
use
(pouches,
trays)
Prep for
sterilization by
stacking them
directly into the
sterilizer or
containing
them in a
basket in the EO penetration
sterilizer
variance due to Inconsistent
loading
SAL
configuration
S
e
v
1
3
Potential
Cause(s)/
Mechanism(
s) of Failure
Stuff too
many units
into basket
or sterilizer
Stuff too
many units
into
basket/cham
ber and/or
stacking of
full baskets
in chamber
O
c
c
u
r
3
2
Current
Design
Controls
Prevention
Current
Design
Controls
Detection
Sponsor
could double
pouch or Analyst and
sterilize in
Sponsor
secondary
visual
packaging or inspection of
use
units
additional
sterilizers
EO sterilizer
qualification
PQ
incorporates PCDs placed
a uniformity throughout
verification chamber,
by Bis
then BI
throughout tested for
fully loaded sterility to
chamber with
verify
dunnage.
Chamber
size is small.
D
e
t
e
c
R.
P.
N.
9
27
1
6
STEPS
3.
List the ef fects of each failure mode identified
a) Best practice: Put it all down, even if crazy!
b) Pitfalls: Don’t avoid putting it down because of low risk
Item /
Function
Potential
Potential Potential S Cause(s)/
Failure Effect(s) of e Mechanis
Mode
Failure v m(s) of
Failure
O Current
D
Current
c Design
e
Design
c Controls
t
Controls
u Preventio
e
Detection
r
n
c
Action Results
Responsi
O D
R. Recommen bility &
S c e R.
P.
ded
Target ActionsTa
e c t P.
N. Action(s) Completio
ken
v u e N.
n Date
r c
What effects could result from the failure occurring?
EXAMPLE: EO CLINICAL BATCH RELEASE PROCESS
Item /
Function
Potential
Potential
Effect(s) of
Failure Mode
Failure
Compromise
integrity of
Unit
primary
unsuitable for
packaging
use
(pouches,
trays)
Prep for
sterilization by
stacking them
directly into the
sterilizer or
containing
them in a
basket in the EO penetration
sterilizer
variance due to Inconsistent
loading
SAL
configuration
S
e
v
1
3
Potential
Cause(s)/
Mechanism(
s) of Failure
Stuff too
many units
into basket
or sterilizer
Stuff too
many units
into
basket/cham
ber and/or
stacking of
full baskets
in chamber
O
c
c
u
r
3
2
Current
Design
Controls
Prevention
Current
Design
Controls
Detection
Sponsor
could double
pouch or Analyst and
sterilize in
Sponsor
secondary
visual
packaging or inspection of
use
units
additional
sterilizers
EO sterilizer
qualification
PQ
incorporates PCDs placed
a uniformity throughout
verification chamber,
by Bis
then BI
throughout tested for
fully loaded sterility to
chamber with
verify
dunnage.
Chamber
size is small.
D
e
t
e
c
R.
P.
N.
9
27
1
6
SCORING
Item /
Function
Potential Failure
Mode
Potential
Effect(s) of
Failure
O
Potential
S
c
Cause(s)/
e
c
Mechanism(s)
v
u
of Failure
r
Current
Design
Controls
Prevention
Current
Design
Controls
Detection
D
e
t
e
c
R.
P.
N.
Action Results
Responsibility
O
Recommended
& Target
S c
Action(s)
Completion ActionsTaken e c
Date
v u
r
D
e R.
t P.
e N.
c
How bad could the effect of the failure be?
Severity of Effect
10
9
8
7
6
5
4
3
2
1
May result in safety issue or regulatory violation without warning
May result in safety issue or regulatory violation with warning
Primary function is lost or seriously degraded
Primary function is reduced and customer is impacted
Secondary function is lost or seriously degraded
Secondary function is reduced and customer is impacted
Loss of function or appearance such that most customers would return product or stop using service
Loss of function or appearance that is noticed by customers but would not result in a return or loss of service
Loss of function or appearance that is unlikely to be noticed by customers and would not result in a return or
loss of service
Little to no impact
EXAMPLE: EO CLINICAL BATCH RELEASE PROCESS
Item /
Function
Potential
Potential
Effect(s) of
Failure Mode
Failure
Compromise
integrity of
Unit
primary
unsuitable for
packaging
use
(pouches,
trays)
Prep for
sterilization by
stacking them
directly into the
sterilizer or
containing
them in a
basket in the EO penetration
sterilizer
variance due to Inconsistent
loading
SAL
configuration
S
e
v
1
3
Potential
Cause(s)/
Mechanism(
s) of Failure
Stuff too
many units
into basket
or sterilizer
Stuff too
many units
into
basket/cham
ber and/or
stacking of
full baskets
in chamber
O
c
c
u
r
Current
Design
Controls
Prevention
Current
Design
Controls
Detection
Sponsor
could double
pouch or Analyst and
sterilize in
Sponsor
secondary
visual
packaging or inspection of
use
units
additional
sterilizers
EO sterilizer
qualification
PQ
incorporates PCDs placed
a uniformity throughout
verification chamber,
by Bis
then BI
throughout tested for
fully loaded sterility to
chamber with
verify
dunnage.
Chamber
size is small.
D
e
t
e
c
Note: We only scored
regulatory risk since the
patient wouldn’t use a
9
compromised device. You may
want to also assess business
risk
3
2
1
R.
P.
N.
27
6
STEPS
4.
List the causes of each failure mode identified
a) Best practice: Remember human factors
b) Pitfalls: Don’t avoid putting it down because of low occurrence
Item /
Function
Potential
Potential Potential S Cause(s)/
Failure Effect(s) of e Mechanis
Mode
Failure v m(s) of
Failure
O Current
D
Current
c Design
e
Design
c Controls
t
Controls
u Preventio
e
Detection
r
n
c
Action Results
Responsi
O D
R. Recommen bility &
S c e R.
P.
ded
Target ActionsTa
e c t P.
N. Action(s) Completio
ken
v u e N.
n Date
r c
What caused the failure to occur?
EXAMPLE: EO CLINICAL BATCH RELEASE PROCESS
Item /
Function
Potential
Potential
Effect(s) of
Failure Mode
Failure
Compromise
integrity of
Unit
primary
unsuitable for
packaging
use
(pouches,
trays)
Prep for
sterilization by
stacking them
directly into the
sterilizer or
containing
them in a
basket in the EO penetration
sterilizer
variance due to Inconsistent
loading
SAL
configuration
S
e
v
1
3
Potential
Cause(s)/
Mechanism(
s) of Failure
Stuff too
many units
into basket
or sterilizer
Stuff too
many units
into
basket/cham
ber and/or
stacking of
full baskets
in chamber
O
c
c
u
r
3
2
Current
Design
Controls
Prevention
Current
Design
Controls
Detection
Sponsor
could double
pouch or Analyst and
sterilize in
Sponsor
secondary
visual
packaging or inspection of
use
units
additional
sterilizers
EO sterilizer
qualification
PQ
incorporates PCDs placed
a uniformity throughout
verification chamber,
by Bis
then BI
throughout tested for
fully loaded sterility to
chamber with
verify
dunnage.
Chamber
size is small.
D
e
t
e
c
R.
P.
N.
9
27
1
6
STEPS
Item /
Function
Potential
Potential Potential S Cause(s)/
Failure Effect(s) of e Mechanis
Mode
Failure v m(s) of
Failure
O Current
D
Current
c Design
e
Design
c Controls
t
Controls
u Preventio
e
Detection
r
n
c
Action Results
Responsi
O D
R. Recommen bility &
S c e R.
P.
ded
Target ActionsTa
e c t P.
N. Action(s) Completio
ken
v u e N.
n Date
r c
How often does this failure mode occur?
Probability of Occurrence
10
9
8
7
6
5
4
3
1 in 2
1 in 10
1 in 50
1 in 250
1 in 1,000
1 in 5,000
1 in 10,000
1 in 50,000
2
1 in 250,000
1
1 in 1 Million
EXAMPLE: EO CLINICAL BATCH RELEASE PROCESS
Item /
Function
Potential
Potential
Effect(s) of
Failure Mode
Failure
Compromise
integrity of
Unit
primary
unsuitable for
packaging
use
(pouches,
trays)
Prep for
sterilization by
stacking them
directly into the
sterilizer or
containing
them in a
basket in the EO penetration
sterilizer
variance due to Inconsistent
loading
SAL
configuration
S
e
v
1
3
Potential
Cause(s)/
Mechanism(
s) of Failure
Stuff too
many units
into basket
or sterilizer
Stuff too
many units
into
basket/cham
ber and/or
stacking of
full baskets
in chamber
O
c
c
u
r
3
2
Current
Design
Controls
Prevention
Current
Design
Controls
Detection
Sponsor
could double
pouch or Analyst and
sterilize in
Sponsor
secondary
visual
packaging or inspection of
use
units
additional
sterilizers
EO sterilizer
qualification
PQ
incorporates PCDs placed
a uniformity throughout
verification chamber,
by Bis
then BI
throughout tested for
fully loaded sterility to
chamber with
verify
dunnage.
Chamber
size is small.
D
e
t
e
c
R.
P.
N.
9
27
1
6
STEPS
5.
List any current controls you have to prevent that failure
a) Best practice: List only what is driven by the procedure
b) Pitfalls: Don’t include per sonal best practices
Item /
Function
Potential
Potential Potential S Cause(s)/
Failure Effect(s) of e Mechanis
Mode
Failure v m(s) of
Failure
O Current
D
Current
c Design
e
Design
c Controls
t
Controls
u Preventio
e
Detection
r
n
c
Action Results
Responsi
O D
R. Recommen bility &
S c e R.
P.
ded
Target ActionsTa
e c t P.
N. Action(s) Completio
ken
v u e N.
n Date
r c
What do you currently have in place to prevent the failure?
EXAMPLE: EO CLINICAL BATCH RELEASE PROCESS
Item /
Function
Potential
Potential
Effect(s) of
Failure Mode
Failure
Compromise
integrity of
Unit
primary
unsuitable for
packaging
use
(pouches,
trays)
Prep for
sterilization by
stacking them
directly into the
sterilizer or
containing
them in a
basket in the EO penetration
sterilizer
variance due to Inconsistent
loading
SAL
configuration
S
e
v
1
3
Potential
Cause(s)/
Mechanism(
s) of Failure
Stuff too
many units
into basket
or sterilizer
Stuff too
many units
into
basket/cham
ber and/or
stacking of
full baskets
in chamber
O
c
c
u
r
3
2
Current
Design
Controls
Prevention
Current
Design
Controls
Detection
Sponsor
could double
pouch or Analyst and
sterilize in
Sponsor
secondary
visual
packaging or inspection of
use
units
additional
sterilizers
EO sterilizer
qualification
PQ
incorporates PCDs placed
a uniformity throughout
verification chamber,
by Bis
then BI
throughout tested for
fully loaded sterility to
chamber with
verify
dunnage.
Chamber
size is small.
D
e
t
e
c
R.
P.
N.
9
27
1
6
STEPS
6.
List all the ways you can currently detect the failure
a) Best practice: List only what is driven by the procedure
b) Pitfalls: Don’t include tribal knowledge or personal best practices
Item /
Function
Potential
Potential Potential S Cause(s)/
Failure Effect(s) of e Mechanis
Mode
Failure v m(s) of
Failure
O Current
D
Current
c Design
e
Design
c Controls
t
Controls
u Preventio
e
Detection
r
n
c
Action Results
Responsi
O D
R. Recommen bility &
S c e R.
P.
ded
Target ActionsTa
e c t P.
N. Action(s) Completio
ken
v u e N.
n Date
r c
What do you currently have in place to detect occurrence of the failure?
EXAMPLE: EO CLINICAL BATCH RELEASE PROCESS
Item /
Function
Potential
Potential
Effect(s) of
Failure Mode
Failure
Compromise
integrity of
Unit
primary
unsuitable for
packaging
use
(pouches,
trays)
Prep for
sterilization by
stacking them
directly into the
sterilizer or
containing
them in a
basket in the EO penetration
sterilizer
variance due to Inconsistent
loading
SAL
configuration
S
e
v
1
3
Potential
Cause(s)/
Mechanism(
s) of Failure
Stuff too
many units
into basket
or sterilizer
Stuff too
many units
into
basket/cham
ber and/or
stacking of
full baskets
in chamber
O
c
c
u
r
3
2
Current
Design
Controls
Prevention
Current
Design
Controls
Detection
Sponsor
could double
pouch or Analyst and
sterilize in
Sponsor
secondary
visual
packaging or inspection of
use
units
additional
sterilizers
EO sterilizer
qualification
PQ
incorporates PCDs placed
a uniformity throughout
verification chamber,
by Bis
then BI
throughout tested for
fully loaded sterility to
chamber with
verify
dunnage.
Chamber
size is small.
D
e
t
e
c
R.
P.
N.
9
27
1
6
STEPS
Item /
Function
Potential
Potential Potential S Cause(s)/
Failure Effect(s) of e Mechanis
Mode
Failure v m(s) of
Failure
O Current
D
Current
c Design
e
Design
c Controls
t
Controls
u Preventio
e
Detection
r
n
c
Action Results
Responsi
O D
R. Recommen bility &
S c e R.
P.
ded
Target ActionsTa
e c t P.
N. Action(s) Completio
ken
v u e N.
n Date
r c
What is the probability of detecting the failure?
Likelihood of Detection
10
9
8
7
6
5
4
3
Absolutely uncertain that failure will be detected
Very remote chance that failure will be detected
Remote chance that failure will be detected
Very low chance that failure will be detected
Low chance that failure will be detected
Moderate chance that failure will be detected
Moderately high chance that failure will be detected
High chance that failure will be detected
2
Very high chance that failure will be detected
1
Almost certainty that failure will be detected
EXAMPLE: EO CLINICAL BATCH RELEASE PROCESS
Item /
Function
Potential
Potential
Effect(s) of
Failure Mode
Failure
Compromise
integrity of
Unit
primary
unsuitable for
packaging
use
(pouches,
trays)
Prep for
sterilization by
stacking them
directly into the
sterilizer or
containing
them in a
basket in the EO penetration
sterilizer
variance due to Inconsistent
loading
SAL
configuration
S
e
v
1
3
Potential
Cause(s)/
Mechanism(
s) of Failure
Stuff too
many units
into basket
or sterilizer
Stuff too
many units
into
basket/cham
ber and/or
stacking of
full baskets
in chamber
O
c
c
u
r
3
2
Current
Design
Controls
Prevention
Current
Design
Controls
Detection
Sponsor
could double
pouch or Analyst and
sterilize in
Sponsor
secondary
visual
packaging or inspection of
use
units
additional
sterilizers
EO sterilizer
qualification
PQ
incorporates PCDs placed
a uniformity throughout
verification chamber,
by Bis
then BI
throughout tested for
fully loaded sterility to
chamber with
verify
dunnage.
Chamber
size is small.
D
e
t
e
c
R.
P.
N.
9
27
1
6
STEPS
7.
Calculate the Risk Product Number
(Severity x Occurrence x Detection)
Item /
Function
Potential
Potential Potential S Cause(s)/
Failure Effect(s) of e Mechanis
Mode
Failure v m(s) of
Failure
O Current
D
Current
c Design
e
Design
c Controls
t
Controls
u Preventio
e
Detection
r
n
c
Action Results
Responsi
O D
R. Recommen bility &
S c e R.
P.
ded
Target ActionsTa
e c t P.
N. Action(s) Completio
ken
v u e N.
n Date
r c
What is an acceptable threshold for your process?
EXAMPLE: EO CLINICAL BATCH RELEASE PROCESS
Item /
Function
Potential
Potential
Effect(s) of
Failure Mode
Failure
Compromise
integrity of
Unit
primary
unsuitable for
packaging
use
(pouches,
trays)
Prep for
sterilization by
stacking them
directly into the
sterilizer or
containing
them in a
basket in the EO penetration
sterilizer
variance due to Inconsistent
loading
SAL
configuration
O
c
c
u
r
S
e
v
Potential
Cause(s)/
Mechanism(
s) of Failure
1
Stuff too
many units
into basket
or sterilizer,
depends on
how many
runs client
wants
3
Stuff too
many units
into
basket/cham
ber and/or
stacking of
full baskets
in chamber
2
3
Current
Design
Controls
Prevention
Current
Design
Controls
Detection
Sponsor
could double
pouch or Analyst and
sterilize in
Sponsor
secondary
visual
packaging or inspection of
use
units
additional
sterilizers
EO sterilizer
qualification
PQ
incorporates PCDs placed
a uniformity throughout
verification chamber,
by Bis
then BI
throughout tested for
fully loaded sterility to
chamber with
verify
dunnage.
Chamber
size is small.
D
e
t
e
c
R.
P.
N.
9
27
1
6
STEPS
8.
Calculate the Risk Product Number
(Severity x Occurrence x Detection)
Item /
Function
Potential
Potential Potential S Cause(s)/
Failure Effect(s) of e Mechanis
Mode
Failure v m(s) of
Failure
O Current
D
Current
c Design
e
Design
c Controls
t
Controls
u Preventio
e
Detection
r
n
c
Action Results
Responsi
O D
R. Recommen bility &
S c e R.
P.
ded
Target ActionsTa
e c t P.
N. Action(s) Completio
ken
v u e N.
n Date
r c
What, if any, actions need to be taken to reduce the risk?
Who is going to do them and when?
RISK MITIGATION PLAN
Action Results
R.
P.
N.
Recommended Action(s)
27
Sterilization
agreement should
delineate client's
responsibility for final
package inspection
prior to use
6
none
Responsibility & Target
Completion Date
ActionsTaken
S
e
v
O
c
c
u
r
D
e
t
e
c
R.
P.
N.
STEPS
9.
Close the loop from actions taken and calculate your new RPN
Item /
Function
Potential
Potential Potential S Cause(s)/
Failure Effect(s) of e Mechanis
Mode
Failure v m(s) of
Failure
O Current
D
Current
c Design
e
Design
c Controls
t
Controls
u Preventio
e
Detection
r
n
c
Action Results
Responsi
O D
R. Recommen bility &
S c e R.
P.
ded
Target ActionsTa
e c t P.
N. Action(s) Completio
ken
v u e N.
n Date
r c
Did your actions taken bring you to an acceptable risk?
LESSONS LEARNED
 PFMEA is a useful tool when:
 You are trying to change an existing process
 You are designing a new process
 You are performing root cause analysis (CAPA)
 PFMEA must be the horse – not the cart
 Procedural/Process changes after PFMEA can negate efforts or add
new risks
 Use dynamically to sync with current procedure
 PFMEA is an excellent training tool
 People performing the process learn the “WHYs” behind control
points and “What” can happen if it is not done right
LESSONS LEARNED
 Controls fail – redundancy is better
 For high risks, don’t just rely on one control. Have a safety net!
 Think outside the scope of your process
 Consider defects of the process prior and how that effects yours
 Audit process after actions
 You typically discover new failure modes you missed the first time
around
 Use constant input from quality system (complaints, CAPAs, etc.)
 Don’t rush, this takes time to do right
 Some have taken me up to 5 meetings to complete
QUESTIONS?

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