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Herkutanto
KETUA KOMITE KESELAMATAN PASIEN
KETUA KONSIL KEDOKTERAN, KKI
Guru Besar Fakultas Kedokteran Universitas Indonesia
HERKUTANTO
TUJUAN PAPARAN
Strategi
Pengendalian Risiko
melalui FMEA
Mengenal langkah2
Failure Mode and
Effect Analysis
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KUALITAS PELAYANAN
(Donabedian)
OUTCOME
PROCESS
STRUCTURE
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SUMBER
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SISTIMATIKA PAPARAN
INTRODUKSI FMEA
KESIMPULAN
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What is FMEA ?
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What is HFMEA ?
Modified by VA NCPS
The objective is to look for all ways for process can fail
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FMEA Terminology
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13
14
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LANGKAH-LANGKAH
ANALISIS MODUS KEGAGALAN & DAMPAKNYA
(JCI )
1.
2.
3.
4.
5.
6.
7.
8.
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OUTPUT
Akar Penyebab
Modus Kegagalan
Proses Baru
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LANGKAH
1 Tetapkan Topik
FMEA dan Bentuk
Tim
2 Gambarkan Alur
Proses
3 Identifikasi Modus
Kegagalan &
Dampaknya
4 Tetapkan Prioritas
Modus Kegagalan
5 Identifikasi Akar
Penyebab Modus
Kegagalan
6 Disain ulang
Proses
Daftar Tim
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event
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Variable team
Complex
Non standardized
Tightly coupled
Hierarchical vs team
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_________________________________________________________
_________________________________________________________
LANGKAH 2 : BENTUK TIM
Ketua
:
____________________________________________________________
Anggota
1. _______________
4.
________________________________________
2. _______________
5.
________________________________________
3. _______________
6.
________________________________________
Notulen? _________________________________________
Apakah semua Unit yang terkait dalam Proses sudah terwakili ?
YA / TIDAK
Tanggal dimulai ____________________ Tanggal selesai ___________________
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Visit the worksite to observe the process, verify that all process &
subprocess steps are correct (Step 3)
3 rd team meeting
Postteam meeting
The advisor or his/ her designee follow up until all actions are
completed
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LANGKAH
1 Tetapkan Topik
FMEA dan Bentuk
Tim
2 Gambarkan Alur
Proses
3 Identifikasi Modus
Kegagalan &
Dampaknya
4 Tetapkan Prioritas
Modus Kegagalan
5 Identifikasi Akar
Penyebab Modus
Kegagalan
6 Disain ulang
Proses
LEMBAR ALUR
PROSES dan SUBPROSES PELAYANAN
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LANGKAH
1 Tetapkan Topik
FMEA dan Bentuk
Tim
2 Gambarkan Alur
Proses
3 Identifikasi Modus
Kegagalan &
Dampaknya
4 Tetapkan Prioritas
Modus Kegagalan
5 Identifikasi Akar
Penyebab Modus
Kegagalan
Identifikasi
Modus Kegagalan &
Dampaknya
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8 Implementasi dan
Monitor Proses30Baru
2.
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3. A risk is the chance, high or low, that any hazard will actually cause
somebody harm.
Risk factors are things that make it more likely that you will develop a
disease or condition. They may be things you can't do anything about,
like gender, family history, or race, or things you can control, like smoking
and diet.
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RISKS
COMPLICATIONS
Allergy
Anaphylactic Rx
Leucocytosis
Sepsis
Bleeding
Hypovolemic shock
Fragile tissues
Tissue damage
Naucea / vomit
Hyponatraemia
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Barrier
Target
Dog
High
Fence
Child
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Medical
Mishaps
Barrier
Policies
Procedures
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Target
Patient
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Selection &
Procurement
Storage
Failure Mode
Failure Mode
Pemesanan obat
Berlebihan (tdk
Sesuai kebthn)
Penyimpanan
vaksin tdk
sesuai suhunya
Prescribing,
Ordering,
Trancribing
Failure Mode
Penulisan obat
dlm R/ tdk jls
Preparing
&
Dispensin
g
Administration
Failure Mode
Failure Mode
Peracikan obat
tdk sesuai dosis
Wrong drug
Wrong dosage
Penulisan Obat R/
tdk R/
Dlm formularium
Wrong frequence
Wrong route
administration
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Assess Risks
Reduce Risks
Verify Effectiveness
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Document Results
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Identify Hazards
Assess Risks
Reduce Risks
Verify Effectiveness
Document Results
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Identify Hazards
Assess Risks
Reduce Risks
Verify Effectiveness
Document Results
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Identify Hazards
Assess Risks
severity of injury
probability of occurrence
Reduce Risks
Verify Effectiveness
Document Results
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Risk matrix:
Severity Category
Identify Hazards
Assess Risks
Reduce Risks
Verify Effectiveness
Document Results
Marginal
Negligible
Frequent
High
High
Serious
Serious
Probable
High
High
Serious
Low
Occasional
High
Serious
Low
Low
Remote
Serious
Low
Low
Low
Improbable
Serious
Low
Low
Low
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Identify Hazards
Assess Risks
Protect
Warn the user
Reduce Risks
Verify Effectiveness
Document Results
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Identify Hazards
Assess Risks
Reduce Risks
This
assessment
verifies
that
the
remedy actions have
reduced the risks to an
acceptable level.
Verify Effectiveness
Document Results
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Identify Hazards
Assess Risks
Reduce Risks
Verify Effectiveness
Document Results
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Threat
Hazard
Threat
Threat
Reactive Controls
Barrier Barrier
Recovery
Measures
People
Barrier Barrier
Recovery
Measures
Asset
Damage
Top Event
(Incident)
Barrier Barrier
Recovery
Measures
Environment
Recovery
Measures
Reputation
Escalation
controls
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C5
X X X X D4,5
E3,4,5
X X X X
C5
X X X X D4,5
E3,4,5
X
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X X X X
X
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LANGKAH
1 Tetapkan Topik
FMEA dan Bentuk
Tim
2 Gambarkan Alur
Proses
3 Identifikasi Modus
Kegagalan &
Dampaknya
4 Tetapkan Prioritas
Modus Kegagalan
5 Identifikasi Akar
Penyebab Modus
Kegagalan
Tetapkan Prioritas
Modus Kegagalan
8 Implementasi dan
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ANALISIS
DAMPA
K
MINOR
1
MAYOR
3
KATASTROPIK
4
Kegagalan dapat
mempengaruhi
proses dan
menimbulkan
kerugian ringan
Kegagalan
menyebabkan kerugian
berat
Kegagalan menyebabkan
kerugian besar
Pasien
Tidak
ada cedera,
Tidak ada
perpanjangan
hari rawat
Cedera
ringan
Ada Perpanjangan
hari rawat
Cedera
luas / berat
Perpanjangan hari
rawat
lebih lama (+> 1 bln)
Berkurangnya fungsi
permanen organ tubuh
(sensorik / motorik /
psikcologik /
intelektual)
Pengunj
ung
Tidak
ada cedera
Tidak ada
penanganan
Terjadi pada 1-2 org
pengunjung
Cedera ringan
Ada Penanganan
ringan
Terjadi pada 2 -4
pengunjung
Kematian
Tidak
Cedera
Staf:
ada cedera
Tidak ada
penanganan
Terjadi pada 1-2 staf
ringan
Cedera luas / berat
Ada Penanganan /
Perlu dirawat
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Tindakan
Kehilangan waktu /
Kehilangan waktu
kecelakaan kerja pada
Kematian
Kehilangan fungsi tubuh
secara permanent (sensorik,
motorik, psikologik atau
intelektual) mis :
Operasi pada bagian atau
pada pasien yang salah,
Tertukarnya bayi
Terjadi
Kematian
Perawatan
> 6 staf
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DESKRIPSI
CONTOH
Sering (Frequent)
Kadang-kadang
(Occasional)
Jarang (Uncommon)
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HAZARD SCORE
TINGKAT BAHAYA
KATASTROPIK
4
MAYOR
3
MODERAT
2
MINOR
1
SERING
4
16
12
KADANG
3
12
JARANG
2
HAMPIR TIDAK
PERNAH
1
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LANGKAH
1 Tetapkan Topik
FMEA dan Bentuk
Tim
2 Gambarkan Alur
Proses
3 Identifikasi Modus
Kegagalan &
Dampaknya
4 Tetapkan Prioritas
Modus Kegagalan
5 Identifikasi Akar
Penyebab Modus
Kegagalan
6 Disain ulang
Proses
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PROBING
to uncover root causes and their relationships
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Human factors
Equipment factors
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DIABETES SCREENING
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Laboratory Test
Ordering Process
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LANGKAH
1 Tetapkan Topik
FMEA dan Bentuk
Tim
2 Gambarkan Alur
Proses
3 Identifikasi Modus
Kegagalan &
Dampaknya
4 Tetapkan Prioritas
Modus Kegagalan
5 Identifikasi Akar
Penyebab Modus
Kegagalan
6 Disain ulang
Proses
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Decision Tree
Gunakan Decision Tree utk menentukan apakah modus perlu tindakan lanjut diProceed
Does this hazard involve a
sufficient likelihood of
occurrence and severity to
warrant that it be controlled?
(Hazard score of 8 or
higher)
YES
NO
NO
YES
Does an effective control measure already exist
for the identified hazard?
CONTROL THE HAZARD (=BARRIER)
NO
Is this hazard so obvious and readily
apparent that a control measure is not
warranted?
DETECTABILITY
(FORESEEABILITY)
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YES
STOP
Do not proceed
to find potential
causes for this
failure mode
YES
NO
Proceed to Potential
Causes for this
failure mode
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PREPARING TO REDESIGN
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REDESIGN STRATEGIES
Prevent the failure from happening
(decrease likelihood of occurrence)
Prevent the failure from reaching the
individual (increase detectability)
Protect individuals if a failure occurs
(decrease the severty of the efects)
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PROSES
RISIKO TINGGI
METODE
REDESIGN
Variable input
Complex
Nonstandarized
Tightly Coupled
Dependent on human
intervention
Time constraints
Hierarchical culture
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Decreasing variability
Simplify
Standardizing
Loosen coupling of process
Use technology
Optimise Redundancy
Built in fail safe mechanism
Documentation
Establishing a culture of
teamwork
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REDESIGN PROCESS
Process
Failure
Mode
Potential
Effect
Potential
Causes
Redesign
Recommend
ations
PIC
Target
Completi
on
date
for test
New
Process
Implementat
ion
date &
Actions
Outcome
Measure /
Monitoring
mechanism
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Proses
Redesign
Bandingkan :
Failure
Mode
Effect
Causes
Failure
Mode
Effect
Causes
Proses Baru
Proses Lama
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LANGKAH
1 Tetapkan Topik
FMEA dan Bentuk
Tim
2 Gambarkan Alur
Proses
3 Identifikasi Modus
Kegagalan &
Dampaknya
4 Tetapkan Prioritas
Modus Kegagalan
5 Identifikasi Akar
Penyebab Modus
Kegagalan
6 Disain ulang
Proses
Le
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SIKLUS PDSA
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SIKLUS PDSA
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LEMBAR KERJA
UJI COBA
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LEMBAR KERJA
UJI COBA
LANGKAH
1 Tetapkan Topik
FMEA dan Bentuk
Tim
2 Gambarkan Alur
Proses
3 Identifikasi Modus
Kegagalan &
Dampaknya
4 Tetapkan Prioritas
Modus Kegagalan
5 Identifikasi Akar
Penyebab Modus
Kegagalan
6 Disain ulang
Proses
Manajemen Perubahan
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KESIMPULAN
PROSES
KEBIJAKAN
RUMAH
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