Risk management by GXP PharmAid
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Risk Management18. november-2013
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Agenda
VelkommenPræsentation af - GXP PharmAid- Share &Learn Gå-hjem-møderRisiko Styring HistorieRisiko Styring FordeleRisiko Styring UlemperRisiko SystemetRiskostyring Værktøjerne
Process FlowFault Tree Analysis (FTA)Cause-Effect Analysis- Fishbone/Ishigawa DiagramFMAFMEAFMECAHACCAPHAZOP
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Risikoens historie 1949: Maskine fremstilling til Militæret 1960: Rumfart & Militær 1988: ISO
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ICH Q9
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Forbedre fejl
Forebyggelse !Byg i processerEliminer utilsigtede fejlStop gør det forkert - Do It Right!SamarbejdeFind sande årsag !Fejl afsløring alarmCheck List
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Hvad er en FMEA ?
Et værktøj, der bruges til at vurdere - de potentielle brudformer og deres årsager
• Prioriterer potentielle fejl i henhold til deres Risiko og drev tiltag for at fjerne eller reducere deres sandsynlighed.
• Giver en disciplin / metode til at dokumentere denne analyse til fremtidig brug og kontinuerlig proces forbedring .
• Med sig selv, er en FMEA IKKE problemløser. Det anvendes i kombination med andre værktøjer til problemløsning . " FMEA præsenterer mulighed , men løser ikke problemet
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Fokus af FMEA
• Kundernes Krav• Engineering Specifikationer• System-og komponenter Specifikationer• Proces-og Leverandør Krav og Kontrol• Udvikle System Design og Process FMEA• Eliminer potentielle fejl• Forbedre Design og Process• Design er den kritiske Element
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FMEA Process
Identificer FunktionerIdentificer fejltilstandeIdentificer Virkninger af Failure ModeBestem Alvorligheden (Severity)Udarbejde Procedure for potentielle konsekvenserIdentificere potentielle årsager til Identificer Rooot cause
Beregn Kritikalitetsindeks Identificer særlige kendetegnIdentificer Design eller Process Control (r)Bestem DetectionRPN (Risk Priority Number)& Final RisikovurderingTræffe foranstaltninger til at mindske risicieneIdentificer særlige kendetegn
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Nogle centrale FMEA Vilkår
• Kunden Input• Team - Team Selection ( Cross -Functional )• Ranking - Graduering af afgørelser• Risk Priority Assessment• Design Proces• Produktions Proces
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Process Mapping
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Trin 1
Trin 2
Trin 4
Trin 5Trin 9 Trin 7 Trin 6
Process Flow
ModtagelseLager Afvejning
Granulering
TabletteringAnalyse
PakningDistribution
Trin 3
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Effect
Cause
Fau
lt Tree A
naly
sis
FM
EA
Assu
mes th
e sy
stem
fails a
nd
dete
rmin
es th
e p
ossib
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use
s
Focu
s is on th
e to
tal sy
stem
Dete
rmin
es
all
the p
oss
ible
ways
a s
yst
em
can f
ail.
Dete
rmin
es
the e
ffect
of
such
failu
res
on t
he s
yst
em
Focu
ses
on
part
s of
whic
h t
he s
yst
em
is
com
pro
mis
ed
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Cause – Effect Diagram (Fishbone /Ishigawa)
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Cause – Effect Diagram (Fishbone /Ishigawa)
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Criteria (consequences) with which to categorize the severity of harm: S-class Severity of harm Consequences
S5 Catastrophic Results in moderate to high probability of death S4 Critical May result in permanent impairment or life-
threatening injury, with low probability of death S3 Serious May result in injury or impairment requiring
professional medical intervention S2 Minor May result in temporary injury or impairment NOT
requiring professional medical intervention S1 Negligible May result in inconvenience or temporary
discomfort
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Acceptance criteria to estimate the probability of occurrence:
P-class Probability of occurrence Range (number of uses)
P5 Frequent 10-2
P4 Probable 10-3 < 10-2
P3 Occasional 10-4 < 10-3
P2 Remote 10-5 < 10-4
P1 Improbable < 10-5
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Acceptance criteria for risk estimation: Probability of Occurrence
Severity of harm
S1 - negligible S2 - minor S3 - serious S4 - critical S5 - catastrophic
P5 - frequent ALAP UNA UNA UNA UNA
P4 - probable ALAP ALAP UNA UNA UNA
P3 - occasional AC ALAP ALAP UNA UNA
P2 - remote AC AC ALAP ALAP UNA
P1 - improbable AC AC AC AC ALAP
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LEAN6SigmaIshigawaBrainstorming
Teams
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