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HERKUTANTO, FMEA 2013 1
Failure Mode and Effect Analysis
Herkutanto
Arjaty/ IMRK 2
STRATEGI REDUKSI RISIKO
HAZARD AND VULNERABILITYASSESSMENT
Infection control rsik assesment
REDISAIN PROSES :
- FMEA
TUJUAN PAPARAN
Strategi Pengendalian
Risiko melalui HVA,ICRA, FMEA
Mengenal langkah2
Failure Mode andEffect Analysis
Herkutanto 2009
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HERKUTANTO, FMEA 2013 2
STRATEGI PENGENDALIAN RISIKO DI
RUMAH SAKIT
1
OSHA Training Institute 6
Hazard and
Vulnerability
Assessment
OSHA Training Institute Region IX
University of California, San Diego (UCSD) - Extension
OSHA Training Institute 7
The Purpose of the HVA
The purpose is a prioritization process that willresult in a risk assessment for all hazards
The tool includes consideration of multiplefactors
The focus is on organization planning andresources and /or the determine that no action
may be required. This is an organization
decision
OSHA Training Institute 8
Is this required?
The Joint Commission, previously called theJoint Commission of Accreditation of Healthcare
Organizations (JCAHO), requests an HVA for
organizations to determine the focus of their
emergency planning
There is no specific tool nor method defined
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HERKUTANTO, FMEA 2013 3
OSHA Training Institute 9
Preparedness
Preparedness of the organizations abilityto manage risks, can include items suchas:
Status of current plans
Training
Insurance
Back up systems
Community resources
OSHA Training Institute 10
Models
There are a number of models for an HVA.
Two well known models are fromAmerican Society of Healthcare Engineering (ASHE)
Kaiser Foundation
Both models can be adjusted to fit the
organization Security organizations and other vendors also
market HVA tools
OSHA Training Institute 11
Medical Center HVA Model
Kaiser model also includes:
Probability
Response factors
Human, property and business impacts, each
considered as a separate issue
OSHA Training Institute 12
A Comparison of Threat Events
Considered in HVA Models
ASHE Model 2001
Human Events
Natural Events Technological Events
Kaiser Foundation
Model 2001
Human Events
Natural Events Technological Events
Hazmat Events
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HERKUTANTO, FMEA 2013 4
OSHA Training Institute 13
References American Society of Healthcare Engineering 2001
WWW.ashe.org
FEMA. Emergency Management Institute Hazardvulnerability analysis and risk assessment. Unit 2
http://www.training.fema.gov/emiweb/EMICourses/E464
CM/02%20Unit%202.pdf
Joint Commission Resources Hazard vulnerability
analysis (HVA), May/Jun 2002, 2-3
OSHA Training Institute 14
OSHA Training Institute 15
OSHA Training Institute 16
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HERKUTANTO, FMEA 2013 5
OSHA Training Institute 17
Arjaty/ IMRK 18
RISK REDUCTION STRATEGIES DIFFICULTY &LONG TERM EFFECTIVENESS
Types of actions Degree of Long term
difficulty effectiveness
Easy Low1. Punitive2. Retraining / counseling
3. Process redesign4. Paper vs practice5. Technical system enhance6. Culture change
Difficult High
Arjaty/ IMRK 19
STRATEGI REDUKSI RISIKO
Identifikasi risiko dgn bertanya 3 pertanyaan dasar :
1. Apa prosesnya ?
2. Dimana risk points / cause?3. Apa yg dapat dimitigate pada dampak
risk points ?
Definisi ProsesTransformasi input menjadi output yg berkaitan dgn
Kejadian, aktivitas dan mekanisme yg terstruktur
Arjaty/ IMRK 20
STRATEGI REDUKSI RISIKO
RENCANAREDUKSI RISIKO
Design Proses u/Meminimalkan
risikokegagalan
Design Proses u/Mengurangi
DampakKegagalan terjadi
pada pasien
Design Proses u/Meminimalkan
risikoKegagalan terjadi
Pada pasien
RISK
POINTS /
COMMON CAUSES
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HERKUTANTO, FMEA 2013 6
Arjaty/ IMRK 21
IDENTIFYING RISK PRONE SYSTEM
Variable input
Complex systems Non standardized systems
Tightly coupled systems
Systems with tight time constraints
Systems with hierarchical
Arjaty/ IMRK 22
ariable input
Pasien Penyakit berat Penyakit penyerta Pernah mendapatkan pengobatan Usia
Pemberi Pelayanan
Tingkat keterampilan
Cara pendekatan
Proses Pelayanan harus dapat mengakomodasivariabilitas yang tdk dapat dihindarkan dan tidak dapatdikontrol ini.
Arjaty/ IMRK 23
Complexitas
Pelayanan rumah sakit sangat kompleks
Memerlukan beragam langkah yang sangat
mungkin berhadapan dengan kegagalan Semakin banyak langkah semakin besar
kemungkinan gagal
Donald Berwick :
1 langkah -- error 1 %
25 langkah -- error 22%
100 langkah -- error 63%
Arjaty/ IMRK 24
Lack of Standardization
Standard - -- proses tidak dapat berjalan
sesuai dengan harapan
Individu yang menjalankan proses harus
melaksanakan langkah langkah yang telah
ditetapkan secara konsisten
Variabilitas individual sangat tinggi -
perlu standard mis : SPO, Parameter, Protokol,Clinical Pathways dapat membatasi pengaruh
dari variabel yang ada.
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HERKUTANTO, FMEA 2013 7
Arjaty/ IMRK 25
Heavily dependent on human Intervention
Ketergantungan yang tinggi akan intervensiseseorang dalam proses dapat menimbulkanvariasi penyimpangan.
Tidak semua improvisasi bersifat buruk, dikenal creating safety at the sharp end
Pelayanan kesehatan sangat tergantung padaintervensi manusia
Petugas harus mampu mengendalikan situasiyang tidak terduga demi keselamatan pasien
Sangat tergantung pada pendidikan dan pelatihanyang memadai sesuai dengan tugas & fungsinya
Arjaty/ IMRK 26
Tightly Coupled
Perpindahan langkah dari suatu proses sering sangatketat, kadang baru disadari terjadi penyimpanganpada langkah yang telah lanjut.
Keterlambatan dalam suatu langkah akanmengakibatkan gangguan pada seluruh proses
Kekeliruan dalam suatu langkah akan mengakibatkan
penyimpangan pada langkah berikut ( cascade offaillure )
Kesalahan biasanya terjadi pada saat perpindahanlangkah atau adanya langkah yang terabaikan
Arjaty/ IMRK 27
Hierarchical culture
Suatu proses akan menghadapi risiko kegagalan lebihtinggi dalam unit kerja dengan budaya hirarki dibandingkandengan unit kerja yang budayanya berorientasi pada team
Staf enggan berkomunikasi & berkolaborasi satu denganyang lain
Perawat enggan bertanya kepada dokter atau petugasfarmasi tentang medikasi, dosis, serta element perawatanlainnya
Budaya hirarki sering tercipta misalnya dalam menentukanpenggunaan obat, verifikasi lokasi pembedahan oleh timbedah.
Tata cara berkomunikasi antar staf dalam prosespelayanan kesehatan sangat menentukan hasilnya.
Arjaty/ IMRK 28
Implementing Safety Cultures in Medic ine:What We Learn by Watching Physic ians
Timothy J . Hoff Henry Pohl J oel Bartfield
Residendi Kamar Bedah : ~Commission
~Suasanahierarki tinggi
~KesalahanTeknis
Residendi MICU : ~Ommission
Suasanahierarkilebihdatar
~ KesalahanPengambilan
Keputusan
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HERKUTANTO, FMEA 2013 8
PENDEKATAN MELALUI FMEA
2
Arjaty/ IMRK 30
What is FMEA ? Adalah metode perbaikan kinerja dgn
mengidentifikasi dan mencegah potensi
kegagalan sebelum terjadi. Hal tersebut
didesain untuk meningkatkan keselamatan
pasien.
Adalah proses proaktif, dimana kesalahan
dpt dicegah & diprediksi. Mengantisipasi
kesalahan akan meminimalkan dampak buruk
Arjaty/ IMRK 31
FMEA Terminology
Process FMEA - Conduct an FMEA on aprocess that is already in place
Design FMEA Conduct an FMEA beforea process is put into place Implementing an electronic medical records or
other automated systems
Purchasing new equipment
Redesigning Emergency Room, OperatingRoom, Floor, etc.
Arjaty/ IMRK 32
FAILURE MODE AND EFFECTS ANALYSIS
FAILURE (F) : When asystem orpart of a system
performs in a way that isnot
intended or desirable
MODE (M) : Theway or manner in which
something such asa failure can
happen. Failure mode is the
manner in which something can
fail.
EFFECTS (E) : The results orc onsequences of a
failure mode
Anal ysi s (A) : The detailedexamination of the
elements or structure of aprocess
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HERKUTANTO, FMEA 2013 9
Arjaty/ IMRK 33
Can prevent errors & nearmisses protectingpatients from harm.
Can increase the effectiveness & efficiency ofprocess
Taking a proactive approach to patient safetyalso makes good business sense in a health
care environment that is increasingly facing
demands from consumers, regulators & payers
to create culture focused on reducing risk &increasing accountability
Why should my organizationconduct an FMEA ?
Arjaty/ IMRK 34
FMEA has been around for over 30 years
Recently gained widespread appeal
outside of safety area
New to healthcare
Frequently used reliability & system safety
analysis techniques
Long industry track record
Where did FMEA come from ?
Arjaty/ IMRK 35
FMEA
Original
HFMEA
By : VA NCPS
HFMECA
By IMRK
1 Select a high risk process &
assemble a team
Define the HFMEA
Topic
Select a high risk process &
assemble a team
2 Diagram the process Assemble the Team Diagram the process
3 Brainstorm potential failure
modes & determine their effects(P X Da X De)
Graphically describe
the Process
Brainstorm potential failure
modes & Prioritize failure modes(P X Da) x K X De, Bands
4 Prioritize failure modes Conduct a Hazard
Analysis
Brainstorm potential effects of
failure modes
(P X Da) x K X De, Bands
5 Id en ti fy root causes of failure
modes
(P X Da X De)
Actions & Outcome
Measures
Identify root causes of failure
modes
(P X Da) x K X De, Bands
6 REDESIGN THE PROCESS CALCUL ATE TOTAL RPN
7 Analyze & test the new process REDESIGN THE PROCESS
8 Implement & monitor the
redesigned process
Analyze & test the new process
9 Implement & monitor the
redesi ned rocess
LANGKAH2 FMEA, HFMEA, HFMECA
Arjaty/ IMRK 36
What is HFMEA ?Modified by VA NCPS
Focus on preventing defects, enhancing safety, increasepositive outcome and increase patient satisfaction
The objective is to look for all ways for process or productcan fail
The famous question : What is could happen? Not Whatdoes happen ?
Hybrid prospective analysis model combines concepts :FMEA (Failure Mode and Effects Analysis)
HACCP (Hazard Analysis Critical Control Points)
RCA (Root Cause Analysis)
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HERKUTANTO, FMEA 2013 10
1. Tetapkan Topik AMKD2. Bentuk Tim3. Gambarkan Alur Proses
4. Buat Hazard Analysis
5. Tindakan dan Pengukuran Outcome
LANGKAH-LANGKAH
ANALISIS MODUS KEGAGALAN & DAMPAK (AMKD)
(HEALTHCARE FAILURE MODE EFFECT AND ANALYSIS)
(HFMEA)
By : VA NCPS
Arjaty/ IMRK 38
TIME LINE AND TEAM ACTIVITIES
P re me et in g Id en ti fy To pi c a nd no ti vy th e t ea m(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
. teammeeting plus 1 Assign team members to follow up individual charged with takingcorrective 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
39
LANGKAH -LANGKAH
FAILURE MODE & EFFECT ANALYSIS
1. Pilih Proses yang berisiko tinggi dan Bentuk Tim
2. GambarkanAlu r Pros es
3. DiskusikanModus Kegagalan potensial dan Dampak
nya
4. Buat prioritas Modus Kegagalan yang akan
diintervensi
5. Identi fikasiAkar Penyebab Modus Kegagalan
6. Disainulangproses / Re-disain Proses
7. Analisa & uji Proses baru
8. Implementasi & MonitorProses baru
Arjaty/ IMRK 40
LANGKAH 1 : PILIH PROSES YANG BERISIKO TINGGI
Pilih Proses berisiko tinggi yang akan dianalisa.
Judul Proses :
__________________________________________________________________________
_________________________________________________________
_________________________________________________________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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HERKUTANTO, FMEA 2013 11
Arjaty/ IMRK 41
Arjaty/ IMRK 42
Arjaty/ IMRK 43
Arjaty/ IMRK 44
ANALISIS HAZARD LEVEL DAMPAKDAMPA
K
MINOR
1
MODERAT
2
MAYOR
3
KATASTROPIK
4
Kegagalan yang tidak
mengganggu Proses
pelayanan kepada
Pasien
Kegagalan dapat
mempengaruhi p roses
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)
Kematian
Kehilangan fungsi tubuh
secara permanent (sensorik,
motorik, psikologik atau
intelektual) mis :
Operasi pada bagian atau
pada pasien yang salah,
Tertukarnya bayi
Pengunju
ng
Tidak ada cedera
Tidak ada penanganan
Terjadi pada 1-2 orgpengunjung
Cedera ringan
Ada Penanganan
ringan Terjadi pada 2 -4
pengunjung
Cedera luas / berat
Perlu dirawat
Terjadi pada 4 -6orang
pengunjung
Kematian
Terjadi pada > 6 orang
pengunjung
Staf: Tidak ada cedera
Tidak ada penanganan
Terjadi pada 1-2 staf
Tidak ada kerugian
waktu / keckerja
Cedera ringan
Ada Penanganan /
Tindakan
Kehilangan waktu /
kec kerja : 2-4 staf
Cedera luas / berat
Perlu dirawat
Kehilangan waktu /
kecelakaan kerja pada
4-6 staf
Kematian
Perawatan > 6 staf
Fasilitas
Kes
Kerugian < 1 000,,000
atau tanpa menimbulkan
dampak terhadap pasien
Kerugian
1,000,000 -
10,000,000
Kerugian
10,000,000 - 50,000,000
Kerugian > 50,000,000
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HERKUTANTO, FMEA 2013 12
Arjaty/ IMRK 45
ANALISIS HAZARD LEVEL PROBABILITAS
LEVEL DESKRIPSI CONTOH
4 Sering (Frequent) Hampir sering muncul dalam waktu yang
relative singkat (mungkin terjadi
beberapa kali dalam 1 tahun)
3 Kadang-kadang
(Occasional)
Kemungkinan akan muncul
(dapat terjadi bebearapa kali dalam 1
sampai 2 tahun)
2 Jarang (Uncommon) Kemungkinan akan muncul
(dapat terjadi dalam >2 sampai 5 tahun)
1 Hampir Tidak Pernah
(Remote)
Jarang sekali terjadi (dapat terjadi dalam
> 5 sampai 30 tahun)
Arjaty/ IMRK 46
TINGKAT B AHAYA
KATASTROPIK
4
MAYOR
3
MODERAT
2
MINOR
1
SERING
416 12 8 4
KADANG
312 9 6 3
JARANG
28 6 4 2
HAMPIR TIDAK
PERNAH
1
4 3 2 1
HAZARD SCORE
Arjaty/ IMRK 47
Does this hazard involve a
sufficient likelihood of
occurrence and severity to
warrant that it be
controlled?
(Hazard score of 8 or
higher) Is this a single point weakness in
the process? (Criticality failure
results in a system failure?)
CRITICALY
Does an effective control measure
already exist for the identified hazard?
CONTROL
Is this hazard so obvious and readily
apparent that a control measure is not
warranted?
DETECTABILITY
STOP
NO
NO
NO
NO
YES
YES
YES
YES
Proceed to
Potential
Causes for
this failure
mode
Do not proceed
to find potential
causes for this
failure mode
Decision TreeGunakan Decision Tree utk menentukan apakah modus perlu tindakan lanjut
diProceed..
Arjaty/ IMRK 48
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HERKUTANTO, FMEA 2013 13
Arjaty/ IMRK 49
50
LANGKAH -LANGKAH
FAILURE MODE & EFFECT ANALYSIS
1. Pilih Proses yang berisiko tinggi dan Bentuk Tim
2. GambarkanAlu r Pros es
3. Diskusikan Modus Kegagalan potensial dan Dampak
nya
4. Buat prioritas Modus Kegagalan yang akan
diintervensi
5. Identi fikasiAkar Penyebab Modus Kegagalan
6. Disainulangproses / Re-disain Proses
7. Analisa & uji Proses baru
8. Implementasi & MonitorProses baru
Arjaty/ IMRK 51
LANGKAH 1 :PILIH PROSES YANG BERISIKO TINGGI & BENTUK TIM
Pilih Proses berisiko tinggi yang akan dianalisa.
Judul Proses : ___________________________________________
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 __________ _____________
Arjaty/ IMRK 52
STEP 2 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
P em es anan ob at P enyi mp anan P enul is an o bat P er ac ikan o bat W ro ng d rug
Berlebihan (tdk vaksin tdk dlm R/ tdk jls tdk sesuai dosis
S es ua i ke bt hn) s es ua i s uh un ya Wrong dosage
PenulisanObat R/tdk R/
Dlm formularium Wrong frequence
Wrong route
administration
Selection &
Procurement
StoragePrescribing,
Ordering,
Trancribing
Preparing
&
Dispensing
Admin istr ation
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HERKUTANTO, FMEA 2013 14
Arjaty/ IMRK 53
Arjaty/ IMRK 54
Proses lama
yg high risk
DesainProses baru
Alur
Proses Potential Cause
Failure
Mode HS
Efek /
Dampak
Decision
Tree
K
K
DT
K
E
Tindakan
HFMEA
Kontrol
Eliminasi
Terima
Kritis
Kontrol
Deteksi
Hazard
Score
Herkutanto 2009
Arjaty/ IMRK 56
RATING SYSTEM
(Modified b y IMRK)
Rat ing Probabil itas
(P)
DAMPAK
(D)
Kontrol
(K)
Deteksi
(D)
1 Remote Minor effect Easy Certain to detect
2 Low likelihood Moderate effect Mpderate
Easy
High likelihood
3 Moderate
likelihood
Minor injury Moderate
difficult
Moderate
likelihood
4 High likelihood Major injury Difficult Low likelihood
5 Certain to
occur
Catastrophic effect
/ terminal injury,
death
Alm ost cer tain
not to detect
Risk Priori ty Numb er (RPN) / Critic aly Index (CI) = (Da x P) x K x De
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HERKUTANTO, FMEA 2013 15
Arjaty/ IMRK 57
Sample Severity Scale(Modified by IMRK)
Rating Description Definition
1 Minor effect or No effect May affect the individual served & w ouldresult in some effect on the proc ess or
Would not be noticeable to individual served
& would not affect the process
2 M od er at e ef fe ct M ay af fe ct th e i nd iv id ua l s er ved & w ou ldresult in a major effect on the process
3 M ino r i nj ur y Wo ul d af fec t t he i nd iv idu al and resu lt in amajor effect on the process
4 Major injury Would result i n a m ajor inj ury for theindividual served and have major effect on
the process
5 Catastrophic effect, aterminal injury or death
Extremely dangerous, failure would result
death of the individual served and have a
major effect on the process
Source : JCR : Joint Commision Resources
Arjaty/ IMRK 58
Rating Description Probability Definition
1 Remote tonon existent
1 in 10,000 No or l i tt le known occurrence h ighly
unlikely that condition will ever occur
2 LowLikelihood
1 in 5000 Poss ib l e, bu t no known data, t he
condition occurs in isolated cases, but
chances are low
3 Moderatelikelihood
1 in 200 Do cu men ted , b ut i nf re qu en tl y, th e
condition has a reasonable chance to
occur
4 Highlikelihood
1 i n 1 00 Do cu men ted a nd f re qu en t, t he
condition occurs very regularly and / or
during a reasonable amount of time
5 Certain tooccur
1 in 20 Do cum en ted , al mo st cer tai n, th e
condition will inevitably occur during
long periods typical for the step or link
Sample Probability of Occurrence Scale(Modified by IMRK)
Arjaty/ IMRK 59
Sample Detectability Scale(Modified by IMRK)
Rat in g Desc ri pt io n Pr ob ab il ity
of
Detection
Definition
1 Certain todetect
10 out to 10 Almost always detected
immediately
2 High likel ihood 7 out of 10 Likely to be detected
3 Moderatelikelihood
5 out of 10 Moderate l ikel ihood of detect ion
4 Low l i ke li hood 2 out 0 f 10 Un l ikel y to be de tected
5 Alm ost cer tainnot to detect
0 out of 10 Detection not possible at any point
Arjaty/ IMRK 60
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HERKUTANTO, FMEA 2013 16
Arjaty/ IMRK 61
STEP 5 IDENTIFY ROOT CAUSES OF FAILURE MODES
Failure Mode Potential
effect
Potenti
alcauses
Severity Probabi li t
y
Ri
skSc
or
e
(3
X4
)
Risk
Categories /
Bands
C on tr ol D et ec tion R PN
(5X8X9)
1 2 3 4 5 1 2 3 4 5 1-25
L M H E 1 2 3 4 1 2 3 4 5
1 2 3 4 5 6 7 8 9 10
Wrong route
administration
Death No
Training
X X 10 E X X 40
Wrong
frequency
Injury with
permanent loss offunction >
No
recordinChart
X X 12 E X X 24
Wrong
dosage
No injury
with nopermanen
t loss of
function
Miss
readinstruct
ion
X X 8 H X X 32
Wro ng d ru g N o injur y
but LOS >
Miss
identification
X X 4 H X X 16
Arjaty/ IMRK 62
STEP 6 CALCULA TE TOTAL RPN
No Failure
Mode
RPN
FailureMode
Potential
effect
RPN
effect
Potential
Causes
RPN
Causes
Total
RPN
Rank
1 2 3 4 5 6 7 8 9
1 Wro ng rou te
administrati
on
60 Death 40 No
Traini
ng
40 140 1
2 Wrong
frequency
48 Injury with
permane
nt lossof
function
12 No record
in
Chart
24 84 3
3 Wrong dosage 36 No injury
with nopermanent loss
offunction
36 Miss read
instruction
32 104 2
4 Wrong drug 36 No injury but
LOS > >
16 Miss
identificati
on
16 68 4
Arjaty/ IMRK 63
STEP 7 REDESIGN PROCESS
Pro ce ss F ai lu re
Mode
Potential
Effect
Potential
Causes
Redesign
Recommendatio
ns
PIC Targ et
Completio
n
date
for test
New
ProcessImplementa
tion
date &
Actions
Outcome
Measure /Monitoring
mechanism
1 2 3 4 5 6 7 8 9
Arjaty/ IMRK 64
TAKE A DEEP BREATH
Conduct a literature search to gather
relevant information from the professional
literature. Do not reinvent the wheel
Network with colleagues
Recommit to out of the box thinking
PREPARING TO REDESIGN
(step 6)
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HERKUTANTO, FMEA 2013 17
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)
Arjaty/ IMRK 65
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HERKUTANTO, FMEA 2013 18
Arjaty/ IMRK 71
REDISAIN PROSES
Variable input Complex
Nonstandarized
Tightly Coupled
Dependent on humanintervention
Time constraints
Hierarchical culture
Decreasing variability Simplify
Standardizing
Loosen coupling of process
Use technology
Optimise Redundancy
Built in fail safe mechanism
Documentation
Establishing a culture of
teamwork
Arjaty/ IMRK 72
LANGKAH 8
ANALISIS DAN UJI PROSES BARU
The team again completes steps 2 (diagram theprocess), step 3 (brainstorm potential failuremodes & determine their effect) and step 4(prioritize failure modes) of the FMEA process
Then the team should calculate a new criticalityindex (CI) or RPN.
Design improvements should bring reduction inthe CI / RPN.
Ex: 30 50% reduction ?
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HERKUTANTO, FMEA 2013 19
Arjaty/ IMRK 73
LANGKAH 9
IMPLEMENTASI DAN MONITORING PROSES
Strategies for Creating & Managing the Change Process :
1. Establish a sense of urgency2. Create a guiding coalition
3. Develop a vision and strategy
4. Communicate the changed vision
5. Empower broad based action
6. Generate short term wins
7. Consolidate gains and produce more change
8. Anchor new approaches in the culture
Arjaty/ IMRK 74
Proses lama
yg high risk
DesainProses baru
Alur
Proses Potential Cause
Failure
Mode HS
Efek /
Dampak
Decision
Tree
K
K
DT
K
E
Tindakan
AMKD / HFMEA
Kontrol
Eliminasi
Terima
Kritis
Kontrol
Deteksi
Hazard
Score
Arjaty/ IMRK 75
AMKDP / HFMECA
Prioritas
risiko
Total RPN
PROSES
LAMA
Failure
Mode,
Dampak,
Penyebab
RedisignProses
Analisis &
Uji Proses BaruTotal RPNPROSESBARU
Failure
Mode,
Dampak,
Penyebab
Implementasi
PROSES BARU
Total RPN
30-50%?
Arjaty/ IMRK 76
KESIMPULANBuilding a safe healthcaresystem
L E A D E R S H I P
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