HERKUTANTO 7
SISTIMATIKA PAPARAN
8
INTRODUKSI FMEA & HFME A
HERKUTANTO 9
What is FMEA ?
Adalah metode perbaikan kinerja dgn
mengidentifikasi dan mencegah potensi
kegagalan sebelum terjadi. Hal tersebut
didesain untuk meningkatkan keselamatan
pasien.
Mengantisipasi
Adalah prosesproaktif, dimana
Kesalahan dpt dicegah & diprediksi.
kesalahan akan meminimalkan dampak
buruk
HERKUTANTO 10
What is HFMEA ?
Modified by VA NCPS
The objective is to look for all ways for process can fail
HERKUTANTO 11
FMEA Terminology
Process FMEA - Conduct an FMEA on a
process that is already in place
HERKUTANTO 18
LANGKAH
1 Tetapkan Topik
FMEA dan Bentuk
Tim
2 Gambarkan Alur
Proses
3 Identifikasi Modus
1 Kegagalan &
Dampaknya
4 Tetapkan Prioritas
Modus Kegagalan
5 Identifikasi Akar
Penyebab Modus
Kegagalan
6 Disain ulang
Proses
TETAPKAN TOPI K & TIM 7 Analisis dan Uji
Coba Proses
Baru
8 Implementasi dan
HERKUTANTO Monitor Proses
19
Baru
TUJUAN & HASIL
Daftar Tim
HERKUTANTO 20
21
TUJUAN PEMILIHAN TOPIK
Fokus pada proses spesifik yang dianggap
prioritas (hospital specific)
Melakukan tindakan korektif pada proses
melalui redesign proses
Contoh:
Proses pelayanan Transfusi darah
Proses pemberian obat kepada pasien
HERKUTANTO 22
LANGKAH 1 : PILIH PROSES YANG BERISIKO TINGGI
Judul Proses :
Ketua :
Anggota 1. 4.
2. 5.
3. 6.
Notulen?
Apakah semua Unit yang terkait dalam Proses sudah terwakili ? YA / TIDAK
Tanggal dimulai Tanggal selesai
HERKUTANTO 24
TIME LINE AND TEAM ACTIVITIES
Premeeting Identify Topic and notivy the team (Step 1 & 2)
1st team meeting Diagram the process, identify subprocess, verify the scope
2rd team meeting Visit the worksite to observe the process, verify that all process &
subprocess steps are correct (Step 3)
3 rd team meeting Brainstorming failure modes, assign individual team members to
consult with process users (Step 3)
4rd team meeting Identify failure modes causes, assign individual team members to
consult with process users for additional input (Step 3)
5th team meeting Transfer FM & Causes to the HFMEA Worksheet (Step3). Begin the
hazard analysis (Step 4)
Identify corrective actios and assign follow up responsibilities (Step 5)
6th,7th , 8th. team Assign team members to follow up individual charged with taking
meeting plus 1 corrective action
team meeting plus 2 Refine corrective actions based on feedback
team meeting plus 3 Test the proposed changes
team meeting plus 4 Meet with Top Management to obtain approval for all actions
Postteam meeting The advisor or his/ her designee follow up until all actions are
completed
HERKUTANTO 25
LANGKAH
1 Tetapkan Topik
FMEA dan Bentuk
Tim
2 Gambarkan Alur
Proses
3 Identifikasi Modus
2 Kegagalan &
Dampaknya
4 Tetapkan Prioritas
Modus Kegagalan
5 Identifikasi Akar
Penyebab Modus
Kegagalan
6 Disain ulang
Proses
Gambarkan Alur Proses 7 Analisis dan Uji
Coba Proses
Baru
8 Implementasi dan
HERKUTANTO Monitor Proses
26
Baru
TUJUAN & HASIL
HERKUTANTO 27
HERKUTANTO 28
HERKUTANTO 29
LANGKAH
1 Tetapkan Topik
FMEA dan Bentuk
Tim
2 Gambarkan Alur
Proses
3 Identifikasi Modus
Kegagalan &
3 Dampaknya
4 Tetapkan Prioritas
Modus Kegagalan
5 Identifikasi Akar
Penyebab Modus
Kegagalan
HERKUTANTO 31
HAZARD vs RISK vs.
COMPLICATIONS
1. A hazard is something that can cause harm, e.g. electricity, chemicals,
working up a ladder, noise, a keyboard, a bully at work, stress, etc. [...
tindakan medik ...??]
2. Complications are things that happen as a result of a disease or a
treatment that you prefer didn't happen [stroke from hypertension, or
bleeding following surgery]
A complication may be described as an adverse event caused by pre-
existing factors that were outside the doctors control. Patients are not the
same in health, habits, immunity or healing power, and have varying susceptibility
to complications
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. HERKUTANTO 32
DIFFERENCES BETWEEN RISKS vs COMPLICATIONS
RISKS COMPLICATIONS
Allergy Anaphylactic Rx
Leucocytosis Sepsis
High
Dog Fence Child
HERKUTANTO 35
HERKUTANTO 36
HERKUTANTO 37
HERKUTANTO 38
HERKUTANTO 39
HERKUTANTO 40
Hazard, Barrier, Target Analysis
Medical Policies
Procedures Patient
Mishaps
HERKUTANTO 41
PENERAPAN HBA PADA FMEA
Prinsip: the DEVILS are in the DETAILS
HERKUTANTO 42
DIAGRAM THE PROCESS
PROCESS STEPS :
Describe the process graphically, according to your policy & procedure for the activity and number each one
If the process is complex you may want to select one process step or sub process to work on
1 2 3 4 5
Failure Mode Failure Mode Failure Mode Failure Mode Failure Mode
Penulisan Obat R/
tdk R/
Dlm formularium Wrong frequence
Wrong route
administration
HERKUTANTO 43
Hazard analysis: What is it?
becoming reality.
Hazard analysis: What is it?
Identify Hazards
Assess Risks
Reduce Risks
Verify
Effectiveness
HERKUTANTO
HE 45
Docum nt Results
e
Hazard analysis: What is it?
Verify Effectiveness
Identify Hazards
Two risk factors are used:
Assess Risks
severity of injury
Derive Risk Rating
probability of occurrenc
Reduce Risks
Verify Effectiveness
Verify Effectiveness
Identify Hazards
Assess Risks
Reduce Risks
The documentation can be added to a
technical file for future use.
Verify Effectiveness
Recovery
Threat Barrier Barrier People
Measures
Recovery Asset
Threat Barrier Barrier Measures Damage
Hazard Top Event
(Incident)
Recovery
Threat Barrier Barrier Environment
Measures
Recovery
Measures Reputation
Escalation
controls
HERKUTANTO 53
Completed Hazards & Effects Register
C5
X X X X X X X X X X D4,5 X
E3,4,5
X X X X X X X X
C5
X X X X X X X X X X D4,5
E3,4,5
E3,4
X X X X X X X X X
HERKUTANTO 54
Step 4A. Hazard Ente
r
Analysis: failur mod for
List result
(CPRS
potential
proces ste e es each )
s Rev
p. Verify Run Rn Repor
cal brat QC Sampl t
ew
Centrifug on e resu t
order
e
3A 38
specime 3C 3 3 3f
Faillure nFailure Failure Failure e lfai lure
Mode: Mode: Mode: V Mo : Mode:
lfai l1.1re
1.Wrong 1 .. Equiip. 1.lnstr 1.QCMode 1.Mecha 1 Computer
test broken not results ni crash
ordered 2..Wrong calibrate unacceptab error 2 Res1.1lt
speed d le 2.Te,ch ,ente ed
2.0rde:r
3.. 2.Bad err for wrong pt.
not
Specime1111 ca I ibra i 3 Computer
received ot
o1n l1nerface
c!lotted error
st.oired HHEERRKKUUTTAAN
4.. No power NTTOO 4 Res1.1lt
5..Wrong not
LANGKAH
1 Tetapkan Topik
FMEA dan Bentuk
Tim
2 Gambarkan Alur
Proses
3 Identifikasi Modus
4 Kegagalan &
Dampaknya
4 Tetapkan Prioritas
Modus Kegagalan
5 Identifikasi Akar
Penyebab Modus
Kegagalan
8 Implementasi dan
Monitor Proses Baru
HERKUTANTO 56
TUJUAN & HASIL
HERKUTANTO 57
Decoding I.he HFM EA"' Wotl<sl\e,et
..
i::;
re moo,, Potential C uses .. :J:! " .. iii Ratiicmale fa
I a
;ZI "' i!!u'
r
la E ..:,
Subprocess number Failure Made Tihis space should be rett blank, unless your
+ Fai'lure Mode num hazard analys5 determined a slop aclior1. In llhat
ber + Cause identifier case, yau v.oukl fist llhe rationa!e la stopping.
HHEERRKKUUTTAAN 58
NTTOO
ANALISIS HAZARD LEVEL DAMPAK
DAMPA MINOR MODERAT MAYOR KATASTROPIK
K 1 2 3 4
Kegagalan yang tidak Kegagalan dapat Kegagalan Kegagalan menyebabkan
mengganggu Proses mempengaruhi menyebabkan kerugian kerugian besar
pelayanan kepada proses dan berat
Pasien menimbulkan
kerugian ringan
Pasien Tidak ada cedera, Cedera ringan Cedera luas / berat Kematian
Tidak ada Ada Perpanjangan Perpanjangan hari Kehilangan fungsi tubuh
perpanjangan hari rawat rawat secara permanent (sensorik,
hari rawat lebih lama (+> 1 bln) motorik, psikologik atau
Berkurangnya fungsi intelektual) mis :
permanen organ tubuh Operasi pada bagian atau
(sensorik / motorik / pada pasien yang salah,
psikcologik / Tertukarnya bayi
intelektual)
Pengunj Tidak ada cedera Cedera ringan Cedera luas / berat Kematian
ung Tidak ada Ada Penanganan Perlu dirawat Terjadi
pada > 6 orang
penanganan ringan Terjadi pada 4 -6 pengunjung
Terjadi pada 1-2 org Terjadi pada 2 -4 orang
pengunjung pengunjung pengunjung
Staf: Tidak ada cedera Cedera ringan Cedera luas / berat Kematian
Tidak ada Ada Penanganan / Perlu dirawat Perawatan > 6 staf
penanganan Tindakan HERKUT ANTO ilangan waktu /
Keh 59
Terjadi pada 1-2 staf Kehilangan waktu kecelakaan kerja pada
ANALISIS HAZARD LEVEL PROBABILITAS
HERKUTANTO 60
HAZARD SCORE
TINGKAT BAHAYA
KATASTROPIK MAYOR MODERAT MINOR
4 3 2 1
SERING 16 12 8 4
4
KADANG 12 9 6 3
3
JARANG 8 6 4 2
2
HAMPIR TIDAK 4 3 2 1
PERNAH
1
HERKUTANTO 61
HERKUTANTO 62
HERKUTANTO 63
Laboratory Test Ordering Process
HERKUTANTO 64
LANGKAH
1 Tetapkan Topik
FMEA dan Bentuk
Tim
2 Gambarkan Alur
Proses
3 Identifikasi Modus
5 Kegagalan &
Dampaknya
4 Tetapkan Prioritas
Modus Kegagalan
5 Identifikasi Akar
Penyebab Modus
Kegagalan
6 Disain ulang
Identifikasi Akar Penyebab Proses
7 Analisis dan Uji
Modus Kegagalan Coba Proses
Baru
8 Implementasi dan
HERKUTANTO Monitor Proses
65
Baru
TUJUAN & HASIL
HERKUTANTO 66
Possible Characteristics of Root
Causes
HERKUTANTO 68
PROBING
to uncover root causes and their relationships
Equipment factors
nonfunctional paging system that delays
communication with the individuals physician
HERKUTANTO 70
Questions to Uncover Causes
What safeguards are missing in the process?
If the process already contains safeguards (for
example, double checks), why might they not work to
prevent the failure every time?
HERKUTANTO 71
What could
happen?
HERKUTANTO
72
Contributory Factors to Suicide
happen?
What could
HERKUTANTO 73
DIABETES SCREENING
happen?
What could
HERKUTANTO 74
Laboratory Test
Ordering Process
HERKUTANTO 75
LANGKAH
1 Tetapkan Topik
FMEA dan Bentuk
Tim
2 Gambarkan Alur
Proses
3 Identifikasi Modus
6 Kegagalan &
Dampaknya
4 Tetapkan Prioritas
Modus Kegagalan
5 Identifikasi Akar
Penyebab Modus
Kegagalan
6 Disain ulang
Proses
Disain Ulang Proses 7 Analisis dan Uji
Coba Proses
Baru
8 Implementasi dan
HERKUTANTO Monitor Proses
76
Baru
TUJUAN & HASIL
HERKUTANTO 77
Decision Tree
Gunakan Decision Tree utk menentukan apakah modus perlu tindakan lanjut diProceed
HERKUTANTO 79
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)
HERKUTANTO 80
PROSES METODE
RISIKO TINGGI REDESIGN
Variable input
Decreasing variability
Complex Simplify
Nonstandarized Standardizin
Tightly Coupled g
Loosen coupling of process
Dependent on Use technology
human intervention Optimise Redundancy
Built in fail safe mechanism
Time constraints
Documentatio
Hierarchical culture n
Establishing a culture of
teamwork
HERKUTANTO 81
REDESIGN PROCESS
Process Failure Potential Potential Redesign PIC Target New Outcome
Mode Effect Causes Recommend Completi Process Measure /
ations on Implementat Monitoring
date ion mechanism
for test date &
Actions
1 2 3 4 5 6 7 8 9
HERKUTANTO 82
Proses
Redesign
Bandingkan :
Failure Failure
Effect Causes Effect Causes
Mode Mode
7 Kegagalan &
Dampaknya
4 Tetapkan Prioritas
Modus Kegagalan
5 Identifikasi Akar
Penyebab Modus
Kegagalan
6 Disain ulang
Analisis dan Uji Coba Proses
7 Analisis dan Uji
Proses Baru Coba Proses
Baru
8 Implementasi dan
HERKUTANTO Monitor Proses
84
Baru
TUJUAN & HASIL
Le
HERKUTANTO 85
SIKLUS PDSA
HERKUTANTO 86
SIKLUS PDSA
ERKUTANTO 87
LEMBAR KERJA
UJI COBA
HERKUTANTO
88
LEMBAR KERJA
UJI COBA
HERKUTANTO
89
LANGKAH
1 Tetapkan Topik
FMEA dan Bentuk
Tim
2 Gambarkan Alur
Proses
3 Identifikasi Modus
8 Kegagalan &
Dampaknya
4 Tetapkan Prioritas
Modus Kegagalan
5 Identifikasi Akar
Penyebab Modus
Kegagalan
6 Disain ulang
Implementasi & Monitor Proses
7 Analisis dan Uji
Proses Baru Coba Proses
Baru
8 Implementasi
HERKUTANTO dan Monitor 90
Proses Baru
TUJUAN & HASIL
HERKUTANTO 91
Strategies for Creating and Managing
the Change Process
HERKUTANTO 93
LEMBAR MONITOR PROSES BARU
HERKUTANTO 94
KESIMPULAN
HERKUTANTO 95
HERKUTANTO 96