Risk Analysis Evaluation

1 2 3 4 5 6 9 10 11 12
Module/ Potential Potential Potential Severity Existing Probability
ID Analyses Risk
Compone Failure Cause(s) Effect of (prior to Control (before
Battery Loose Broken Battery not Training /
OP09 pFMEA LL Negligible Improbable 1
Charge Conector conector usable MPI
Connector
not Fail
Battery Loose Training /
OP09 pFMEA LL Battery Negligible Improbable 1
Charge Conector properly MPI
affixed Test
disconect
Battery
battery
disconect Incomplet
Battery from rack Training /
OP09 pFMEA LL befor e Charge Negligible Improbable 1
Charge befor MPI
finishing Test
finishing
cycle
cycle
Underchar
Incorrect
ged or
Battery charging Operator Training /
OP09 pFMEA LL over Minor Remote 5
Charge profile error MPI
charge
selected
battery
Assembly
Handset
Missing and
Unpack Missing Incoming
OP10 pFMEA LL unit from testing Negligible Improbable 1
Install Handset Inspection
supplier cannot
Battery
occur
Handset
Damaged Device
Unpack Damaged Incoming
OP10 pFMEA LL unit from fails Minor Remote 5
Install unit Inspection
supplier testing
Battery
Assembly
Handset
Missing Missing and
Unpack Incoming
OP10 pFMEA LL Handset foot from testing Negligible Improbable 1
Install Inspection
foot supplier cannot
Battery
occur
Handset Damage Training /
Unpack due to Improper Damaged MPI /
OP10 pFMEA LL Serious Improbable 6
Install unpacking handling Handset Material
Battery methods Handling

Handset Re Training /
Unpack Damaged Improper packaged MPI /
OP10 pFMEA LL Negligible Remote 2
Install box handling cannot Incoming
Battery occur Inspection
Damaged
Handset Training /
cables Handset
Unpack Improper MPI /
OP10 pFMEA LL during malfunctio Serious Remote 9
Install handling Material
battery n
Battery Handling
install
 Handset
Unpack Damaged Improper Leaking Incoming
OP10 pFMEA LL Critical Improbable 10
Install battery handling battery Inspection
Battery
Handset Battery
Damaged Damaged
Unpack cannot Incoming
OP10 pFMEA LL battery battery Negligible Improbable 1
Install plug in to Inspection
Connector Connector
Battery unit
Battery
Battery connector Battery
Handset connector cannot connector
Unpack cannot positively comes Incoming
OP10 pFMEA LL Negligible Improbable 1
Install positively engage to unplugged Inspection
Battery engage to unit due to during
unit supplier device use
damaged

Battery
Battery connector Battery
Handset connector cannot connector Training /
Unpack cannot positively comes MPI /
OP10 pFMEA LL Negligible Improbable 1
Install positively engage to unplugged Material
Battery engage to unit due to during Handling
unit operator device use
damaged

Serial
Handset number
Serial
Unpack mis-match Regulatory Incoming
OP10 pFMEA LL number Critical Improbable 10
Install found in risk Inspection
mis-match
Battery raw
material

Serial
number
Handset Training /
mis-match Serial
Unpack Regulatory MPI /
OP10 pFMEA LL applying number Critical Improbable 10
Install risk Material
incorrect mis-match
Battery Handling
foot to
handset

Seal is not
Handset positively Training /
Incorrectly Leaking
Unpack made MPI /
OP10 pFMEA LL perform of into Minor Remote 5
Install between Material
operation handset
Battery base and Handling
handset
Handset Screws Screw Cover is, Training /
Unpack are not Driver or MPI /
OP10 pFMEA LL Minor Remote 5
Install properly malfunctio becomes, Material
Battery tightened n loose Handling
 Handset Cover is, Training /
Unpack Missing Improper or MPI /
OP10 pFMEA LL Minor Remote 5
Install Screws handling becomes, Material
Battery loose Handling
Device is
Process
Mode not switch Training /
OP20 pFMEA LL step was Test fails Negligible Improbable 1
Change in proper MPI
omitted
mode.

Device is
Fixture Tool
Mode not switch Fail Dose
OP20 pFMEA LL malfunctio Negligible Setup / Improbable 1
Change in proper test
n Calibration
mode.
Incorrect
chamber
Auto Dose
program false pass Training /
OP30 pFMEA LL Test User error Critical Remote 14
selection / false fail MPI
(Handset)
for
handset
Operator
Test rig
Auto Dose places the
fails to Training /
OP30 pFMEA LL Test device in False Fail Minor Remote 5
detect end MPI
(Handset) wrong
of dose
position
Incorrect
Test rig
Auto Dose setting up
fails to Maintenan
OP30 pFMEA LL Test of False Fail Minor Remote 5
detect end ce / MPI
(Handset) microphon
of dose
e
Auto Dose Balance Incorrect
false pass Calibration
OP30 pFMEA LL Test malfunctio usage of Critical Remote 14
/ false fail / Training
(Handset) ned balance
Balance
Auto Dose set up Incorrect
false pass Training /
OP30 pFMEA LL Test incorrectly set up of Critical Remote 14
/ false fail MPI
(Handset) (Tare and balance
level)
Auto Dose Cradle Maintenan
Does not No
OP30 pFMEA LL Test battery low Negligible ce / Improbable 1
initiate test Readings
(Handset) charge Calibration

Auto Dose Extractor

Incorrect Training /
OP30 pFMEA LL Test position False fail Minor Remote 5
reading MPI
(Handset) incorrect

Auto Dose Extractor

Incorrect Maintenan
OP30 pFMEA LL Test maintenan False fail Minor Remote 5
reading ce
(Handset) ce missed
 Auto Dose Extractor
Incorrect Training /
OP30 pFMEA LL Test not turned False fail Minor Remote 5
reading MPI
(Handset) on
Control
chambers
Auto Dose
Incorrect not used false pass Training /
OP30 pFMEA LL Test Critical Improbable 10
reading or / false fail MPI
(Handset)
uncontroll
ed
Control
Auto Dose chambers
Incorrect false pass
OP30 pFMEA LL Test not to Critical Calibration Improbable 10
reading / false fail
(Handset) specificati
on
Control
Auto Dose
Incorrect chambers false pass Maintenan
OP30 pFMEA LL Test Critical Improbable 10
reading not being / false fail ce
(Handset)
maintaned
Incorrect
Auto Dose Latching
low dose Training /
OP30 pFMEA LL Test of the lid False fail Minor Remote 5
data MPI
(Handset) incorrect
reading
No
Auto Dose segregatio Send bad
Operator Training /
OP30 pFMEA LL Test n of non parts to Critical Remote 14
error MPI
(Handset) conformin customer
g parts
Auto Dose False
Disturbing Operator Training /
OP30 pFMEA LL Test pass / Critical Remote 14
work table error MPI
(Handset) False fail

Auto Dose Pippet False

Operator Training /
OP30 pFMEA LL Test risks pass / Critical Remote 14
error MPI
(Handset) (incorrect) False fail
Pippet
risks -
Auto Dose False
Incorrect Operator Training /
OP30 pFMEA LL Test pass / Critical Remote 14
use or error MPI
(Handset) False fail
filling of
chamber

Comunicat
ion missed
beetween
Auto Dose Time Process, False
Training /
OP30 pFMEA LL Test Calibration Calibration pass / Critical Remote 14
MPI
(Handset) Expired and False fail
production
Departme
nt
 Particle Spraytec Send bad
Incorrect Setup /
OP40 pFMEA LL Test incorrect parts to Critical Remote 14
Test result Calibration
(Handset) setup customer
Incorrect
Test result Incorrect Work
Particle Send bad
Due to Work instruction
OP40 pFMEA LL Test parts to Critical Remote 14
incorrect instruction review for
(Handset) customer
Spraytec transfer transfer
set up

Incorrect
Test result
Inadequat
Particle Due to Send bad
e Maintenan
OP40 pFMEA LL Test incorrect parts to Critical Remote 14
maintenan ce / MPI
(Handset) Extraction customer
ce
Maintenan
ce

Operator
Complex
Particle not False
process / Training /
OP40 pFMEA LL Test following pass/ Critical Remote 14
operator MPI
(Handset) work False fail
error
instruction
Poor
Particle Abnormal False
condition Maintenan
OP40 pFMEA LL Test backgroun pass/ Critical Remote 14
of cell ce / MPI
(Handset) d False fail
insert
Particle Dirty lens False
Incorrect Maintenan
OP40 pFMEA LL Test used for pass/ Critical Remote 14
Test result ce / MPI
(Handset) testing False fail
Particle High
Unable to Maintenan
OP40 pFMEA LL Test backgroun Dirty lens Negligible Remote 2
test ce
(Handset) d
Particle High
Unable to Training /
OP40 pFMEA LL Test backgroun Dirty lens Negligible Remote 2
test MPI
(Handset) d spike
Incorrect
data from
particle - Misinterpr
Particle Send bad
incorrect etation of Training /
OP40 pFMEA LL Test parts to Critical Remote 14
parameter test MPI
(Handset) customer
used results
(dv50 -
dv90)
Particle Spraytec incorrect False
Training /
OP40 pFMEA LL Test started sequence pass/ Critical Remote 14
MPI
(Handset) late execution False fail
Particle Spraytec incorrect False
Training /
OP40 pFMEA LL Test started sequence pass/ Critical Remote 14
MPI
(Handset) early execution False fail
Particle Not incorrect
Training /
OP40 pFMEA LL Test starting sequence No results Negligible Remote 2
MPI
(Handset) handset execution
 Incorrect
handset/c
Particle False
Air Leak in onnector/ Maintenan
OP40 pFMEA LL Test pass/ Critical Improbable 10
system mouthpice ce
(Handset) False fail
and throat
assembly

Particle Pippet False

Operator Training /
OP40 pFMEA LL Test risks pass / Critical Improbable 10
error MPI
(Handset) (incorrect) False fail
Pippet
risks -
Particle False
Incorrect Operator Training /
OP40 pFMEA LL Test pass / Critical Improbable 10
use or error MPI
(Handset) False fail
filling of
chamber
Enviromen
Particle Test tal False
Training /
OP40 pFMEA LL Test sample conditions pass / Critical Remote 14
MPI
(Handset) not stable out of False fail
spec
Drug / Drug / Patient
Particle saline is saline is doesn't
Training /
OP40 pFMEA LL Test left on left on receive Serious Remote 9
MPI
(Handset) device and device and clean
horn horn device
No
Particle segregatio Send bad
Operator Training /
OP40 pFMEA LL Test n of non parts to Critical Remote 14
error MPI
(Handset) conformin customer
g parts
Particle Poor
Handset is Handset is Training /
OP40 pFMEA LL Test Segregatio Critical Remote 14
not tested not tested MPI /DHR
(Handset) n
Control
chambers
Particle
Incorrect not used Incorrect Training /
OP40 pFMEA LL Test Critical Remote 14
reading or test result MPI
(Handset)
uncontroll
ed
Control
Particle chambers
Incorrect Incorrect
OP40 pFMEA LL Test not to Critical Calibration Remote 14
reading test result
(Handset) specificati
on
Control
Particle
Incorrect chambers Incorrect Maintenan
OP40 pFMEA LL Test Critical Remote 14
reading not being test result ce
(Handset)
maintaned
Vacuum
Particle
Incorrect sourse Incorrect Maintenan
OP40 pFMEA LL Test Critical Remote 14
reading with salt test result ce
(Handset)
residues
 Vacuum
Particle
Incorrect filter not Incorrect Maintenan
OP40 pFMEA LL Test Critical Remote 14
reading being test result ce
(Handset)
changed
Typo error
while
capturing The Incorrect
Particle Handset's operator informatio
Training /
OP40 pFMEA LL Test Serial may wrote n related Serious Ocassional 13
MPI
(Handset) number or a Typo by in result
WO in misstake sheet
Spraytec
Software

Comunicat
ion missed
beetween
Particle Time Process, False
Training /
OP40 pFMEA LL Test Calibration Calibration pass / Critical Remote 14
MPI
(Handset) Expired and False fail
production
Departme
nt

Pacient
potencial
Device is
Process recivied
Mode not switch Training /
OP50 pFMEA LL step was device Minor Remote 5
Change in proper MPI
omitted incorrect
mode.
settings
overdose
Pacient
Device is potencial
Fixture Maintenan
Mode not switch recivied
OP50 pFMEA LL malfunctio Minor ce / Remote 5
Change in proper device
n Calibration
mode. incorrect
settings
Pacient
potencial
Device is recivied
Process
Mode not switch device Training /
OP50 pFMEA LL step was Minor Remote 5
Change in proper incorrect MPI
omitted
mode. settings
unable to
use divice
Assembly
and
Handset Missing Improper Incoming
OP60 pFMEA LL testing Negligible Remote 2
Repack Box handling Inspection
cannot
occur
Handset Damaged Improper Unable to Incoming
OP60 pFMEA LL Negligible Remote 2
Repack Box handling re pack Inspection
 Damage Training /
Handset box due to Improper Unable to MPI /
OP60 pFMEA LL Negligible Remote 2
Repack repacking handling re pack Material
methods Handling

Training /
Damaged
Handset Damaged Damaged MPI /
OP60 pFMEA LL box due to Negligible Remote 2
Repack box unit Incoming
drops
Inspection

Serial
number Serial
Handset Regulatory Incoming
OP60 pFMEA LL mis-match number Critical Remote 14
Repack risk Inspection
(handset mis-match
to box)

Training /
Storage
regulatory MPI /
OP75 pFMEA LL Sub Assy Mix Lots Mix Lots Critical Remote 14
issues Incoming
Room
Inspection

Incorrect Incorrect Training /

Storage client
kit kit MPI /
OP75 pFMEA LL Sub Assy disatisfacti Critical Remote 14
configurati configurati Incoming
Room on
on on Inspection
Assembly
Missing and
Chamber supplier Incoming
OP80 pFMEA LL chamber testing Minor Remote 5
Unpack issue Inspection
in box cannot
occur
Damaged chamber
Chamber supplier Incoming
OP80 pFMEA LL unit inside fails Minor Remote 5
Unpack issue Inspection
box testing

Damage Training /
Chamber due to Improper Damaged MPI /
OP80 pFMEA LL Minor Remote 5
Unpack unpacking handling chamber Material
methods Handling

Training /
Chamber Damaged Improper Damaged MPI /
OP80 pFMEA LL Minor Remote 5
Unpack box handling box Incoming
Inspection
Pippet
risks
Wrong
Dose Test (incorrect false pass Training /
OP90 pFMEA LL among Critical Remote 14
Chamber or / false fail MPI
dispensed
uncalibrat
ed etc)
Handset
Dose Test Does not false pass
OP90 pFMEA LL battery low Critical OP09 Improbable 10
Chamber initiate test / false fail
charge
 Not
False following
Dose Test work
false pass Training /
OP90 pFMEA LL passed Critical Remote 14
Chamber instructions / false fail MPI
test

Incorrect Unleveled
Dose Test data from scale false pass calibration
OP90 pFMEA LL Critical Remote 14
Chamber scale / false fail / MPI
testing
Incorrect scale not
Dose Test data from calibrated false pass
OP90 pFMEA LL Critical QCP Remote 14
Chamber scale / false fail
testing
Incorrect Door not
Dose Test data from closed false pass Training /
OP90 pFMEA LL propertly Critical Remote 14
Chamber scale / false fail MPI
testing
Incorrect Extractor
Dose Test data from dont turn false pass Training /
OP90 pFMEA LL on Critical Remote 14
Chamber scale / false fail MPI
testing
Dead/Low
Dose Test Unable to battery No Training /
OP90 pFMEA LL Minor Remote 5
Chamber test Readings MPI
unstable
tareed maitenanc
Dose Test balance false pass
OP90 pFMEA LL balance Critical e/ Remote 14
Chamber not tare / false fail
calibration
wrong incomplete
Dose Test dispence false pass Training /
OP90 pFMEA LL among of Critical Remote 14
Chamber / false fail MPI
water
wrong spill water
Dose Test duuring false pass Training /
OP90 pFMEA LL among of Critical Remote 14
Chamber handdling / false fail MPI
water
foreing
incorrect material /
Dose Test excess
false pass Training /
OP90 pFMEA LL balance Critical Remote 14
Chamber water on / false fail MPI
reading
scale
Incorrect Control
Dose Test data from Handset false pass calibration
OP90 pFMEA LL out of spec Critical Remote 14
Chamber scale / false fail / MPI
testing
Incorrect Incorrect
Dose Test low dose pipete false pass Training /
OP90 pFMEA LL setting Critical Remote 14
Chamber data / false fail MPI
reading
incorrect
pipete use
(for non-
Dose Test Incorrect metered false pass Training /
OP90 pFMEA LL Critical Remote 14
Chamber test data chsambers / false fail MPI
only)
 Incorrect underfill
Dose Test low dose saline level false pass Training /
OP90 pFMEA LL Critical Remote 14
Chamber data / false fail MPI
reading
Incorrect Filling
Dose Test low dose wrong false pass Training /
OP90 pFMEA LL cavity Critical Remote 14
Chamber data / false fail MPI
chamber
reading
Incorrect Not latched
Dose Test low dose false pass Training /
OP90 pFMEA LL Critical Remote 14
Chamber data / false fail MPI
reading
Process
Dose Test Non Zero step not false pass Training /
OP90 pFMEA LL Critical Remote 14
Chamber Scale followed / false fail MPI
Handset
Unable to location Far
Dose Test detect the from the Incomplet Training /
OP90 pFMEA LL microphone e test Minor Remote 5
Chamber sound MPI
(beep)

Incorrect touching
Dose Test low dose the sides Training /
OP90 pFMEA LL walls False fail Minor Improbable 3
Chamber data MPI
reading
Incorrect Chamber to
Dose Test low dose far from Training /
OP90 pFMEA LL extractor False fail Minor Remote 5
Chamber data MPI
hose
reading
Incorrect Wrong test
Dose Test selected false pass Training /
OP90 pFMEA LL data Critical Remote 14
Chamber / false fail MPI
reading
Making
Incorrect
Dose Test contact with false pass Training /
OP90 pFMEA LL data work table / false fail Critical Remote 14
Chamber MPI
reading
Incorrect Sending
Accepting recording
Dose Test bad part to Training /
OP90 pFMEA LL defective data results Critical Remote 14
Chamber the MPI
parts
customer
Poor Sending
Accepting segregation Line
Dose Test bad part to
OP90 pFMEA LL defective Critical clerance / Remote 14
Chamber the
parts MPI
customer

Comunicat
ion missed
beetween
Time Process, False
Dose Test Training /
OP90 pFMEA LL Calibration Calibration pass / Critical Remote 14
Chamber MPI
Expired and False fail
production
Departme
nt
 Inconming
Damaged not
Intermedia Improper Inspection
OP100 pFMEA LL Compone functonal Minor Remote 5
te Clean handling / Line
nts chamber
clerance
Intermedia Miss TAG Improper Incorrect Training /
OP100 pFMEA LL Minor Remote 5
te Clean ID handling DHR info MPI
Patient
maitenanc
Intermedia Parts not unchange receive
OP100 pFMEA LL Minor e/ Remote 5
te Clean clean d water Unclean
calibration
device
Patient
too much
Intermedia soap receive Training /
OP100 pFMEA LL soap Minor Remote 5
te Clean residue Unclean MPI
residue
device
Patient
Intermedia soap Rinse not receive Training /
OP100 pFMEA LL Minor Remote 5
te Clean residue performed Unclean MPI
device
Patient
Process
Intermedia Parts not receive Training /
OP100 pFMEA LL step was Minor Remote 5
te Clean clean Unclean MPI
omitted
device
Patient
too much Excessive
Intermedia receive Training /
OP100 pFMEA LL soap use of Minor Remote 5
te Clean Unclean MPI
residue soap
device
unable to Training /
Chamber parts Improper
OP101 pFMEA LL assemble Minor MPI / Remote 5
Lid Dry damage handling
d Calibration
customer
removed
received Training /
Chamber incomplet from oven
OP101 pFMEA LL contamina Minor MPI / Remote 5
Lid Dry e dry befor
ted Calibration
drying
product
customer
Timer not received Training /
Chamber incomplet
OP101 pFMEA LL working contamina Minor MPI / Remote 5
Lid Dry e dry
properly ted Calibration
product

Comunicat
ion missed
beetween customer
Time Process, received
Chamber
OP101 pFMEA LL Calibration Calibration contamina Serious Calibration Remote 9
Lid Dry
Expired and ted
production product
Departme
nt
 unable to Training /
Chamber parts Improper
OP102 pFMEA LL assemble Minor MPI / Remote 5
Base Dry damage handling
d Calibration
customer
removed
received Training /
Chamber incomplet from oven
OP102 pFMEA LL contamina Minor MPI / Remote 5
Base Dry e dry befor
ted Calibration
drying
product
customer
Timer not received Training /
Chamber incomplet
OP102 pFMEA LL working contamina Minor MPI / Remote 5
Base Dry e dry
properly ted Calibration
product
customer
Oven not
Chamber incomplet received Training /
OP102 pFMEA LL working Minor Remote 5
Base Dry e dry wet MPI
properly
product
prolonged
heat Potential
Chamber Broken maintenan
OP102 pFMEA LL exposure damaged Minor Remote 5
Base Dry equipment ce
extended parts
drying
prolonged Not
heat following Potential
Chamber Training /
OP102 pFMEA LL exposure work damaged Minor Remote 5
Base Dry MPI
extended instruction parts
drying s
drying
temperatu
Potential
Chamber re not Equipment maintenan
OP102 pFMEA LL damaged Minor Remote 5
Base Dry controlled failure ce
parts
(high and
low)

Comunicat
ion missed
beetween customer
Time Process, received
Chamber
OP102 pFMEA LL Calibration Calibration contamina Serious Calibration Remote 9
Base Dry
Expired and ted
production product
Departme
nt

Spraytec Send bad

Particle Incorrect Setup /
OP110 pFMEA LL incorrect parts to Critical Remote 14
Test Test result Calibration
setup customer
Incorrect
Maintenan
Particle Incorrect Test result Incorrect
OP110 pFMEA LL Serious ce / Remote 9
Test Test result out of Test result
Calibration
range
 Maintenan
Particle Incorrect
OP110 pFMEA LL Dirty lens No results Negligible ce / Remote 2
Test Test result
Calibration
High
Particle Unable to Maintenan
OP110 pFMEA LL backgroun Dirty lens Negligible Remote 2
Test test ce
d
High
Particle Unable to Training /
OP110 pFMEA LL backgroun Dirty lens Negligible Remote 2
Test test MPI
d spike
Enviromen
High tal
Particle Training /
OP110 pFMEA LL backgroun conditions No test Negligible Remote 2
Test MPI
d out of
spec
Misinterpr
Incorrect Send bad
Particle etation of Training /
OP110 pFMEA LL data from parts to Critical Remote 14
Test test MPI
particle customer
results
incorrect
Particle No Test Incomplet Training /
OP110 pFMEA LL secuence Negligible Remote 2
Test Result e test MPI
execution
Incomplet Handset
Particle false pass Training /
OP110 pFMEA LL e sample started Critical Remote 14
Test / false fail MPI
taken late
Incorrect
Test
Particle handset false pass Training /
OP110 pFMEA LL sample Critical Improbable 10
Test mouthpice / false fail MPI
not stable
assembly
not
Incomplet
Particle enough false pass Training /
OP110 pFMEA LL e sample Critical Improbable 10
Test saline / false fail MPI
taken
solution
Enviromen
Test tal
Particle false pass Training /
OP110 pFMEA LL sample conditions Critical Improbable 10
Test / false fail MPI
not stable out of
spec
wrong Operator
Particle false pass Training /
OP110 pFMEA LL data pass a Critical Remote 14
Test / false fail MPI
analisys failed unit
Untested
Particle Handset is Handset is chamber Training /
OP110 pFMEA LL Critical Remote 14
Test not tested not tested is sent to MPI
customer
Setting not Incorrect
Particle Training /
OP110 pFMEA LL correct - pipette set Fails Test Minor Remote 5
Test MPI
too high up
Vacuum
Particle Incorrect sourse Incorrect Maintenan
OP110 pFMEA LL Critical Remote 14
Test reading with salt test result ce
residues
 Vacuum
Particle Incorrect filter not Incorrect Maintenan
OP110 pFMEA LL Critical Remote 14
Test reading being test result ce
changed
Setting not
Particle Incorrect
OP110 pFMEA LL correct - Fails Test Minor Calibration Remote 5
Test pipette cal
too high

Typo error
while
capturing The Incorrect
Handset's operator informatio
Particle Training /
OP110 pFMEA LL Serial may wrote n related Serious Ocassional 13
Test MPI
number or a Typo by in result
WO in misstake sheet
Spraytec
Software

Comunicat
ion missed
beetween
Time Process, False
Particle Training /
OP110 pFMEA LL Calibration Calibration pass / Critical Remote 14
Test MPI
Expired and False fail
production
Departme
nt

Chamber Water not Equipment Incomplet Maintenan

OP121 pFMEA LL failure Serious Remote 9
Lid Boil boiling e clean ce
Chamber Water not Process Incomplet Training /
OP121 pFMEA LL not follow Serious Remote 9
Lid Boil boiling e clean MPI
Water
Chamber Basket not level too Incomplet Training /
OP121 pFMEA LL Serious Remote 9
Lid Boil submerge low e clean MPI
clean time
customer
too short-
Chamber Parts not timer out of
received
OP121 pFMEA LL Serious QCP Remote 9
Lid Boil clean calibration unclean
product
clean time
potencial customer
too long-
Chamber damage timer out of
received
OP121 pFMEA LL Negligible QCP Remote 2
Lid Boil componen calibration bad
t product
clean time customer
Chamber Parts not too short- received
OP121 pFMEA LL timer set to unclean Serious Calibration Remote 9
Lid Boil clean
short
product
potencial clean time customer
Chamber damage too long- received Training /
OP121 pFMEA LL timer set Negligible Remote 2
Lid Boil componen bad MPI
too long
t product
 too much too much Soap
Chamber soap Training /
OP121 pFMEA LL soap contamint Minor Remote 5
Lid Boil MPI
residue ation
Too little customer
Chamber Parts not soap received Training /
OP121 pFMEA LL Negligible Remote 2
Lid Boil clean unclean MPI
product
Water not customer Training /
Chamber Parts not replace received MPI /
OP121 pFMEA LL Serious Remote 9
Lid Boil clean unclean Maintenan
product ce
dirty rinse customer Training /
Chamber Parts not tank-water received MPI /
OP121 pFMEA LL not replace unclean Serious Remote 9
Lid Boil clean Maintenan
product ce
Chamber Process Training /
OP121 pFMEA LL Miss ID Mix Lots Serious Remote 9
Lid Boil Not Follow MPI
DI Water
customer
generator
Chamber Parts not failure for
received Maintenan
OP121 pFMEA LL Serious Remote 9
Lid Boil clean boiling bath unclean ce
product
DI water Process customer
Chamber not use for Not Follow received Training /
OP121 pFMEA LL Serious Remote 9
Lid Boil boiling unclean MPI
bath product
unable to Training /
Chamber parts Improper
OP122 pFMEA LL assemble Minor MPI / Remote 5
Lid Dry damage handling
d Calibration
customer
removed
received Training /
Chamber incomplet from oven
OP122 pFMEA LL contamina Minor MPI / Remote 5
Lid Dry e dry befor
ted Calibration
drying
product
customer
Timer not received Training /
Chamber incomplet
OP122 pFMEA LL working contamina Minor MPI / Remote 5
Lid Dry e dry
properly ted Calibration
product

Comunicat
ion missed
beetween customer
Time Process, received
Chamber
OP122 pFMEA LL Calibration Calibration contamina Serious Calibration Remote 9
Lid Dry
Expired and ted
production product
Departme
nt
 remove
Chamber Inspection
the metal Lose
OP131 pFMEA LL Base Mix lots Serious / Training / Remote 9
tag/missin traceability
wash MPI
g tag
Chamber Process not
temperatu follow Incomplet Training /
OP131 pFMEA LL Base Minor Remote 5
re too low e clean MPI
wash
incorrect
Chamber
setting Process Incomplet Training /
OP131 pFMEA LL Base Minor Remote 5
(fault Not follow e clean MPI
wash
setting)
potencial Process customer
Chamber Not Follow Training /
damage received
OP131 pFMEA LL Base Serious MPI / Remote 9
componen bad
wash Calibration
t product
Dishwasher customer
Chamber failure
Parts not received Maintenan
OP131 pFMEA LL Base Serious Remote 9
clean unclean ce
wash
product
unable to Training /
Chamber parts Improper
OP132 pFMEA LL assemble Minor MPI / Remote 5
Base Dry damage handling
d Calibration
customer
removed
received Training /
Chamber incomplet from oven
OP132 pFMEA LL contamina Minor MPI / Remote 5
Base Dry e dry befor
ted Calibration
drying
product
customer
Timer not received Training /
Chamber incomplet
OP132 pFMEA LL working contamina Minor MPI / Remote 5
Base Dry e dry
properly ted Calibration
product
customer
Oven not
Chamber incomplet received Training /
OP132 pFMEA LL working Minor Remote 5
Base Dry e dry wet MPI
properly
product
prolonged
heat Potential
Chamber Broken maintenan
OP132 pFMEA LL exposure damaged Minor Remote 5
Base Dry equipment ce
extended parts
drying
prolonged Not
heat following Potential
Chamber Training /
OP132 pFMEA LL exposure work damaged Minor Remote 5
Base Dry MPI
extended instruction parts
drying s
drying
temperatu
Potential
Chamber re not Equipment maintenan
OP132 pFMEA LL damaged Minor Remote 5
Base Dry controlled failure ce
parts
(high and
low)
 Comunicat
ion missed
beetween customer
Time Process, received
Chamber
OP132 pFMEA LL Calibration Calibration contamina Serious Calibration Remote 9
Base Dry
Expired and ted
production product
Departme
nt

not Incorrect lost

matching tags/proce traceability Training /
OP140 pFMEA LL Repack Critical Remote 14
the lots ss not /regulatory MPI
numbers followed issues
not lost
Training /
matching missing traceability
OP140 pFMEA LL Repack Critical MPI / Line Remote 14
the lots tags /regulatory
clerance
numbers issues
Transcripti
on error lost
incorrect from traceability Training /
OP140 pFMEA LL Repack Critical Remote 14
lot number chamber /regulatory MPI
or DHR to issues
label SW
Transcripti
on error lost
Wrong lot from traceability Training /
OP140 pFMEA LL Repack chamber Critical Remote 14
format /regulatory MPI
or DHR to issues
label SW
incorrect artwork lost
label issue in traceability Training /
OP140 pFMEA LL Repack Critical Remote 14
template/a the label /regulatory MPI
rtwork file issues
potencial
wrong wrong Training /
OP140 pFMEA LL Repack mislabel label file Critical Remote 14
product MPI
selected shipped
Unable
Ilegible printer Maintenan
OP140 pFMEA LL Repack read the Critical Remote 14
label failure ce
barcode
lost Training /
Ilegible traceability MPI /
OP140 pFMEA LL Repack printer Critical Remote 14
label /regulatory Maintenan
failure issues ce
incorrect Wrong
quantity Training /
OP140 pFMEA LL Repack quantity mix lots Critical Remote 14
entry MPI
labels

Print is not label stock

too incomplet Training /
fitting in
OP140 pFMEA LL Repack small/incor e label/lost Critical MPI / Line Remote 14
the label
rect part traceability clerance
size
number
 Folding
label over
label not label stock the Training /
OP140 pFMEA LL Repack fitting the too edge/cust Critical MPI / Line Remote 14
box Large/inco omer clerance
rrect part unsatisfact
number ion
Process
missing not cosmetic Training /
OP140 pFMEA LL Repack Minor Remote 5
bags followed issues MPI
Handling/
Damage Process cosmetic Training /
OP140 pFMEA LL Repack not Minor Remote 5
bag issues MPI
followed
Incorrect
Fold Process cosmetic Training /
OP140 pFMEA LL Repack not Minor Remote 5
configurati issues MPI
on followed
Torn box Bad cannot Training /
OP140 pFMEA LL Repack handling Serious Remote 9
Lid use box MPI
Torn box Bad cannot Training /
OP140 pFMEA LL Repack handling Serious Remote 9
flap use box MPI
Unable to
Mouthpiec close the
Training /
OP140 pFMEA LL Repack e not Process box/canno Serious Remote 9
MPI
inverted not t insert the
followed drug guide
customer
Missing process unable to Training /
OP140 pFMEA LL Repack Critical Remote 14
drug guide not use the MPI
followed unit
bag not
chamber folded cannot Training /
OP140 pFMEA LL Repack Serious Remote 9
is not fit properly close box MPI
Process customer
misaligned not Training /
OP140 pFMEA LL Repack Dissatisfa Minor Remote 5
label followed MPI
ction
lost
Partial
traceability Incoming
OP140 pFMEA LL Repack attached Lack of Critical Remote 14
/regulatory Inspection
label adhesive issues
contamina lost
Partial tion on traceability Incoming
OP140 pFMEA LL Repack attached surface Critical Remote 14
/regulatory Inspection
label box issues
lost
missing Process traceability Training /
OP140 pFMEA LL Repack not Critical Remote 14
label /regulatory MPI
followed issues
 Mix Part
numer
Training /
Storage (Incorrect over dose
Mix Part MPI /
OP75 pFMEA LL Sub Assy part or under Critical Remote 14
numer Incoming
Room packed dose
Inspection
than
identified)
Training /
Storage
regulatory MPI /
OP75 pFMEA LL Sub Assy Mix Lots Mix Lots Critical Remote 14
issues Incoming
Room
Inspection
Storage
Damaged Bad Undable to Training /
OP75 pFMEA LL Sub Assy Negligible Remote 2
Parts handling use MPI
Room
incorrect artwork lost
label issue in traceability Training /
OP180 pFMEA LL Print Label Critical Remote 14
template/a the label /regulatory MPI
rtwork file issues
potencial
wrong wrong Training /
OP180 pFMEA LL Print Label mislabel label file Critical Remote 14
product MPI
selected shipped
Wrong process
not wrong Exp Training /
OP180 pFMEA LL Print Label date Critical Remote 14
followed date MPI
format
Wrong
OP180 pFMEA LL Print Label date Incorrect wrong Exp Critical Training /
Remote 14
format data entry date MPI

wrong Exp premature Decrease Training /

OP180 pFMEA LL Print Label Critical Remote 14
date calculation shelf life MPI
Exp date
Calculate Exp
Exp date product
wrong Exp Exceeds Training /
OP180 pFMEA LL Print Label could be Critical Remote 14
date product MPI
used by
Exp patient
Decrease
shelf
life/Exp
wrong Exp Training /
OP180 pFMEA LL Print Label product Critical Remote 14
date MPI
could be
Incorrect used by
data entry patient

Wrong lot Incorrect lost Maintenan

OP180 pFMEA LL Print Label Critical Remote 14
number data entry traceability ce
process
Wrong lot not lost Training /
OP180 pFMEA LL Print Label Critical Remote 14
format followed traceability MPI
 Disc Wrong Process Incorrect
not Catastrop Training /
OP170 pFMEA LL Programm spec programmi Improbable 15
followed hic MPI
ing program ng
Disc wrong Training /
unable to credential Unable to
OP170 pFMEA LL Programm Minor MPI / Remote 5
login s proceed
ing Setup
Disc Unauthoriz Incorrect Training /
Unauthoriz ed Catastrop
OP170 pFMEA LL Programm programmi MPI / Improbable 15
ed access credential hic
ing ng Setup
Disc wrong Process Incorrect
Catastrop Training /
OP170 pFMEA LL Programm program not programmi Improbable 15
hic MPI
ing selected followed ng
Disc Wrong process
not wrong Exp Training /
OP170 pFMEA LL Programm date Critical Remote 14
followed date MPI
ing format
Disc Wrong
Incorrect wrong Exp Training /
OP170 pFMEA LL Programm date Critical Remote 14
data entry date MPI
ing format

Disc
wrong Exp premature Decrease Training /
OP170 pFMEA LL Programm Critical Remote 14
date calculation shelf life MPI
ing
Exp date
Calculate Exp
Disc Exp date product
wrong Exp Exceeds Training /
OP170 pFMEA LL Programm could be Minor Improbable 3
date product MPI
ing used by
Exp patient
Decrease
shelf
Disc life/Exp
wrong Exp Training /
OP170 pFMEA LL Programm product Critical Remote 14
date MPI
ing could be
Incorrect used by
data entry patient

Incorrect
Disc or change incorrect Performan Catastrop Training /
OP170 pFMEA LL Programm programin set up of Improbable 15
ce issue hic MPI
ing g during credential
production s
Disc Poor
Fail to Segregatio Performan Training /
OP170 pFMEA LL Programm Critical Remote 14
program n ce issue MPI
ing
Disc wrong Training /
unable to credentialUnable to Catastrop
OP170 pFMEA LL Programm MPI / Improbable 15
login s proceed hic
ing Setup
Mislabel
product
Disc Incorrect
potencial Catastrop Training /
OP170 pFMEA LL Programm raw Line Improbable 15
failure hic MPI
ing material cleareanc patient
e risk
 Mislabel
product
Disc Incorrect
potencial Catastrop Training /
OP170 pFMEA LL Programm raw Improbable 15
failure hic MPI
ing material Wrong pull patient
from stock risk
Disc IT /
Disc not Software Unable to
OP170 pFMEA LL Programm Minor Maintenan Remote 5
program fails proceed
ing ce
Disc read &
antena Unable to
OP170 pFMEA LL Programm write not Minor Calibration Remote 5
failure proceed
ing match
Programm Reduce
Disc
ing efficienty,c
OP170 pFMEA LL Programm Negligible Calibration Remote 2
exceeds antena alibration
ing
8sec drift indicated

Comunicat
ion missed
beetween Reduce
Disc Time
efficienty,c
OP170 pFMEA LL Programm Calibration Process, Negligible Calibration Remote 2
Calibration alibration
ing Expired
and indicated
production
Departme
nt
Process
Incorrect not Mislabeled Training /
OP190 pFMEA LL Card Disc Critical Remote 14
label data followed product MPI
increase Training /
OP190 pFMEA LL Card Disc Torn label Handling Negligible Remote 2
scrap MPI
Unable
Training /
OP190 pFMEA LL Card Disc Ilegible read the Critical Remote 14
Smudge barcode MPI
Unable incoming
OP190 pFMEA LL Card Disc Ilegible read the Critical Inspection Remote 14
Dirty label barcode / MPI
lost
incoming
traceability
OP190 pFMEA LL Card Disc Ilegible Critical Inspection Remote 14
/regulatory
Smudge issues / MPI
lost
incoming
traceability
OP190 pFMEA LL Card Disc Ilegible Critical Inspection Remote 14
/regulatory
Dirty label issues / MPI
Process customer
misaligned not Training /
OP190 pFMEA LL Card Disc Dissatisfa Minor Remote 5
label followed MPI
ction
lost
Partial
traceability Training /
OP190 pFMEA LL Card Disc attached Lack of Critical Remote 14
/regulatory MPI
label adhesive issues
 contamina lost
Partial tion on traceability Incoming
OP190 pFMEA LL Card Disc attached surface Critical Remote 14
/regulatory Inspection
label card issues
lost
missing Process traceability Training /
OP190 pFMEA LL Card Disc not Critical Remote 14
label /regulatory MPI
followed issues
Process customer
misplace not Training /
OP190 pFMEA LL Card Disc Dissatisfa Minor Remote 5
label followed MPI
ction
Process customer
misaligned not Training /
OP190 pFMEA LL Card Disc Dissatisfa Serious Remote 9
foam tape followed MPI
ction
contamina Lost disc
partial tion on customer Incoming
OP190 pFMEA LL Card Disc attached surface Minor Remote 5
dissatisfac Inspection
foam tape card
tion
Lost disc
partial
customer Incoming
OP190 pFMEA LL Card Disc attached Lack of Minor Remote 5
dissatisfac Inspection
foam tape adhesive
tion
Process customer
misplace not Training /
OP190 pFMEA LL Card Disc Dissatisfa Minor Remote 5
foam tape followed MPI
ction
Process
Film not not Unable to Training /
OP190 pFMEA LL Card Disc Negligible Remote 2
removed followed place disc MPI
Process customer
Misaligme not Training /
OP190 pFMEA LL Card Disc Dissatisfa Minor Remote 5
nt disc followed MPI
ction
Disc place Process customer
Training /
OP190 pFMEA LL Card Disc upside not Dissatisfa Minor Remote 5
MPI
down followed ction
Partial customer
Incoming
OP190 pFMEA LL Card Disc attached Lack of Dissatisfa Minor Remote 5
adhesive Inspection
Disc ction
Partial contamina customer
Incoming
OP190 pFMEA LL Card Disc attached tion on Dissatisfa Minor Remote 5
disc Inspection
Disc ction
Partial contamina customer
Incoming
OP190 pFMEA LL Card Disc attached tion on Dissatisfa Minor Remote 5
adhesive Inspection
Disc ction

Foam tape
Partial upsidedow customer
n Training /
OP190 pFMEA LL Card Disc attached Dissatisfa Minor
(incorrect ction MPI
Disc
adhisive
level)
 incorrect artwork lost
Disc label issue in the traceability Training /
OP200 pFMEA LL Critical Remote 14
Packaging template/a label file /regulatory MPI
rtwork issues
wrong label potencial
Disc file selected wrong Training /
OP200 pFMEA LL mislabel Critical Remote 14
Packaging product MPI
shipped
Wrong process not
Disc followed wrong Exp Training /
OP200 pFMEA LL date Critical Remote 14
Packaging date MPI
format
Wrong Incorrect
Disc data entry wrong Exp Critical Training /
OP200 pFMEA LL date Remote 14
Packaging date MPI
format
Incorrect Decrease
data entry shelf
life/Exp
Disc wrong Exp Training /
OP200 pFMEA LL product Critical Remote 14
Packaging date MPI
could be
used by
patient
Handling
Disc increase Training /
OP200 pFMEA LL Torn label Serious Remote 9
Packaging scrap MPI
Smudge
Disc Unable Training /
OP200 pFMEA LL Ilegible Critical Remote 14
Packaging read label MPI
Dirty label
Disc Unable Incoming
OP200 pFMEA LL Ilegible Critical Remote 14
Packaging read label Inspection
Smudge lost
Disc traceability Training /
OP200 pFMEA LL Ilegible Critical Remote 14
Packaging /regulatory MPI
issues
Dirty label / lost
Disc Detach traceability Incoming
OP200 pFMEA LL Ilegible label Critical Remote 14
Packaging /regulatory Inspection
issues
Lack of lost
Partial adhesive
Disc traceability Incoming
OP200 pFMEA LL attached Critical Remote 14
Packaging /regulatory Inspection
label
issues
contaminati lost
Partial on on box
Disc traceability Incoming
OP200 pFMEA LL attached Critical Remote 14
Packaging /regulatory Inspection
label
issues
Process not lost
Disc missing followed traceability Training /
OP200 pFMEA LL Critical Remote 14
Packaging label /regulatory MPI
issues
Process not customer
Disc misplace followed Training /
OP200 pFMEA LL Dissatisfa Minor Remote 5
Packaging label MPI
ction
 Process not Unable to
Disc Only one followed identify Training /
OP200 pFMEA LL Minor Remote 5
Packaging place label box on MPI
pallet
Bad
Incorrect placement
customer
Disc packaging of Training /
OP200 pFMEA LL Dissatisfa Serious Remote 9
Packaging confuratio componen MPI
ction
n ts inside
the box
Damaged
Build Damaged Boxes increase Training /
OP230 pFMEA LL Minor Remote 5
Boxes Boxes during scrap MPI
assembly
Incorrect
Build Process Product Training /
OP230 pFMEA LL Box Minor Improbable 3
Boxes Not follow wont fit MPI
Selection
Damaged
Build Incorrect Process Training /
OP230 pFMEA LL of Product Serious Improbable 6
Boxes Box Assy Not follow MPI
inside
customer
Build Missing Process Training /
OP230 pFMEA LL Dissatisfa Minor Remote 5
Boxes Box Parts Not follow MPI
ction
Pick Re work
collect customer
incorrect Training /
OP240 pFMEA LL componen Dissatisfa Serious Remote 9
part MPI
ts ction
number
collect Process not customer
Mix Part followed Training /
OP240 pFMEA LL componen Dissatisfa Critical Remote 14
number MPI
ts ction
collect Process not
Mix Lot followed Lost of Training /
OP240 pFMEA LL componen Critical Remote 14
number traceability MPI
ts
No
Part customer
following Training /
OP250 pFMEA LL Build Kits numbers the process Dissatisfa Critical Remote 14
MPI
Mix ction
Lot Lack of
inventory Lost of Training /
OP250 pFMEA LL Build Kits Numbers Critical Remote 14
control traceability MPI
Mix
incorrect process not lost
label followed traceability Training /
OP250 pFMEA LL Build Kits Critical Remote 14
template/a /regulatory MPI
rtwork issues
Incorrect potencial
data entry wrong Training /
OP250 pFMEA LL Build Kits mislabel Critical Remote 14
product MPI
shipped
Incorrect
Wrong data entry incorrect Training /
OP250 pFMEA LL Build Kits Critical Remote 14
MFG Date shelf life MPI
printer
Wrong lot failure lost Maintenan
OP250 pFMEA LL Build Kits Critical Remote 14
number traceability ce
 process not
Wrong lot followed lost Training /
OP250 pFMEA LL Build Kits Critical Remote 14
format traceability MPI
Bom
System Ecos
Miss /
customer Implement
Excess of error
OP250 pFMEA LL Build Kits Dissatisfa Minor ation Improbable 3
componen
ction process
ts in Kit
verification