TUJUAN PAPARAN

Strategi Pengendalian
Risiko melalui HVA,
ICRA, FMEA

Failure Mode and Effect Analysis Mengenal langkah2

Failure Mode and
Effect Analysis
Herkutanto

 STRATEGI REDUKSI RISIKO

 HAZARD AND VULNERABILITY
ASSESSMENT
 Infection control rsik assesment

 REDISAIN PROSES :
- FMEA

Arjaty/ IMRK 2
Herkutanto 2009

HERKUTANTO, FMEA 2013 1

 The Purpose of the HVA
1  The purpose is a prioritization process that will
result in a risk assessment for “all hazards”
 The tool includes consideration of multiple
factors
 The focus is on organization planning and
resources and /or the determine that no action
STRATEGI PENGENDALIAN RISIKO DI  may be required. This is an organization
RUMAH SAKIT decision

OSHA Training Institute 7

Is this required?
Hazard and  The Joint Commission, previously called the
Joint Commission of Accreditation of Healthcare
Vulnerability Organizations (JCAHO), requests an HVA for
organizations to determine the focus of their
Assessment emergency planning
 There is no specific tool nor method defined

OSHA Training Institute – Region IX

University of California, San Diego (UCSD) - Extension

OSHA Training Institute 6 OSHA Training Institute 8

HERKUTANTO, FMEA 2013 2

 Preparedness Medical Center HVA Model
 Preparedness of the organization’s ability  Kaiser model also includes:
to manage risks, can include items such  Probability
as:  Response factors
 Status of current plans  Human, property and business impacts, each

 Training considered as a separate issue

 Insurance
 Back up systems
 Community resources

OSHA Training Institute 9 OSHA Training Institute 11

A Comparison of Threat Events

Models
Considered in HVA Models
 There are a number of models for an HVA.
 Two well known models are from  ASHE Model 2001  Kaiser Foundation
 American Society of Healthcare Engineering (ASHE) Model 2001
 Kaiser Foundation
 Human Events  Human Events
 Both models can be adjusted to fit the  NaturalEvents
 Natural Events
organization
 Technological Events  Technological Events
 Security organizations and other vendors also  Hazmat Events
market HVA tools

OSHA Training Institute 10 OSHA Training Institute 12

HERKUTANTO, FMEA 2013 3

 References
 American Society of Healthcare Engineering 2001
WWW.ashe.org
 FEMA. Emergency Management Institute Hazard
vulnerability 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 13 OSHA Training Institute 15

OSHA Training Institute 14 OSHA Training Institute 16

HERKUTANTO, FMEA 2013 4

 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 Proses
Transformasi input menjadi output yg berkaitan dgn
Kejadian, aktivitas dan mekanisme yg terstruktur
Arjaty/ IMRK 19
OSHA Training Institute 17

RISK REDUCTION STRATEGIES DIFFICULTY & STRATEGI REDUKSI RISIKO

LONG TERM EFFECTIVENESS
RISK
Types of actions Degree of Long term POINTS /
difficulty effectiveness COMMON CAUSES

Easy Low
1. Punitive
2. Retraining / counseling RENCANA
REDUKSI RISIKO
3. Process redesign
4. “Paper vs practice”
5. Technical system enhance
6. Culture change Design Proses u/ Design Proses u/
Design Proses u/
Meminimalkan Mengurangi
Meminimalkan
Difficult High risiko
risiko Dampak
Kegagalan terjadi Kegagalan terjadi
kegagalan
Arjaty/ IMRK 18 Arjaty/ IMRK Pada pasien pada pasien20

HERKUTANTO, FMEA 2013 5

 Complexitas
IDENTIFYING RISK PRONE SYSTEM
 Pelayanan rumah sakit sangat kompleks
 Variable input
 Memerlukan beragam langkah yang sangat
 Complex systems mungkin berhadapan dengan kegagalan
 Non standardized systems  Semakin banyak langkah semakin besar
kemungkinan gagal
 Tightly coupled systems
 Donald Berwick :
 Systems with tight time constraints 1 langkah -- error 1 %
 Systems with hierarchical 25 langkah -- error 22%
100 langkah -- error 63%

Arjaty/ IMRK 21 Arjaty/ IMRK 23

Variable input
Lack of Standardization
Pasien
 Penyakit berat
 Standard - -- proses tidak dapat berjalan
 Penyakit penyerta
 Pernah mendapatkan pengobatan sesuai dengan harapan
 Usia  Individu yang menjalankan proses harus
melaksanakan langkah langkah yang telah
ditetapkan secara konsisten
Pemberi Pelayanan
 Tingkat keterampilan  Variabilitas individual sangat tinggi -
 Cara pendekatan perlu standard mis : SPO, Parameter, Protokol,
Clinical Pathways dapat membatasi pengaruh
Proses Pelayanan harus dapat mengakomodasi
variabilitas yang tdk dapat dihindarkan dan tidak dapat dari variabel yang ada.
dikontrol ini.

Arjaty/ IMRK 22 Arjaty/ IMRK 24

HERKUTANTO, FMEA 2013 6

 Heavily dependent on human Intervention
 Ketergantungan yang tinggi akan intervensi
seseorang dalam proses dapat menimbulkan
variasi penyimpangan.
 Tidak semua improvisasi bersifat buruk, dikenal
“ creating safety at the sharp end “
 Pelayanan kesehatan sangat tergantung pada
intervensi manusia
 Petugas harus mampu mengendalikan situasi
yang tidak terduga demi keselamatan pasien
 Sangat tergantung pada pendidikan dan pelatihan
yang memadai sesuai dengan tugas & fungsinya
Arjaty/ IMRK 25
Hierarchical culture
 Suatu proses akan menghadapi risiko kegagalan lebih
tinggi dalam unit kerja dengan budaya hirarki dibandingkan
dengan unit kerja yang budayanya berorientasi pada team
 Staf enggan berkomunikasi & berkolaborasi satu dengan
yang lain
 Perawat enggan bertanya kepada dokter atau petugas
farmasi tentang medikasi, dosis, serta element perawatan
lainnya
 Budaya hirarki sering tercipta misalnya dalam menentukan
penggunaan obat, verifikasi lokasi pembedahan oleh tim
bedah.
 Tata cara berkomunikasi antar staf dalam proses
pelayanan kesehatan sangat menentukan hasilnya.
Arjaty/ IMRK 27

Tightly Coupled
 Perpindahan langkah dari suatu proses sering sangat Implementing Safety Cultures in Medicine:
ketat, kadang baru disadari terjadi penyimpangan What We Learn by Watching Physicians
pada langkah yang telah lanjut. Timothy J. Hoff, Henry Pohl, Joel Bartfield

 Keterlambatan dalam suatu langkah akan

mengakibatkan gangguan pada seluruh proses Residen di Kamar Bedah : ~ Commission
~ Suasana hierarki tinggi
~ Kesalahan Teknis
 Kekeliruan dalam suatu langkah akan mengakibatkan
penyimpangan pada langkah berikut ( cascade of Residen di MICU : ~ Ommission
faillure ) Suasana hierarki lebih datar
~ Kesalahan Pengambilan
 Kesalahan biasanya terjadi pada saat perpindahan Keputusan
langkah atau adanya langkah yang terabaikan
Arjaty/ IMRK 26 Arjaty/ IMRK 28

HERKUTANTO, FMEA 2013 7


2 process that is already in place
PENDEKATAN MELALUI FMEA 
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
HERKUTANTO, FMEA 2013
FMEA Terminology
 Process FMEA - Conduct an FMEA on a
 Design FMEA – Conduct an FMEA before
a process is put into place
 Implementing an electronic medical records or
other automated systems
 Purchasing new equipment
 Redesigning Emergency Room, Operating
Room, Floor, etc.
Arjaty/ IMRK 31
FAILURE MODE AND EFFECTS ANALYSIS
FAILURE (F) : When a system or part of a system
performs in a way that is not
intended or desirable
MODE (M) : The way or manner in which
something such as a failure can
happen. Failure mode is the
manner in which something can
fail.
EFFECTS (E) : The results or consequences of a
failure mode
Analysis (A) : The detailed examination of the
elements or structure of a process
30 Arjaty/ IMRK 32
8
 LANGKAH2 FMEA, HFMEA, HFMECA®
Why should my organization FMEA HFMEA HFMECA®
Original By : VA NCPS By IMRK
conduct an FMEA ? 1 Select a high risk process & Define the HFMEA
Topic
Select a high risk process &
assemble a team assemble a team
 Can prevent errors & nearmisses  protecting 2 Diagram the process Assemble the Team Diagram the process

patients from harm. 3 Brainstorm potential failure Graphically describe Brainstorm potential failure
modes & determine their effects the Process modes & Prioritize failure modes
 Can increase the effectiveness & efficiency of (P X Da X De) (P X Da) x K X De, Bands

process 4 Prioritize failure modes Conduct a Hazard

Analysis
Brainstorm potential effects of
failure modes
 Taking a proactive approach to patient safety (P X Da) x K X De, Bands
5 Identify root causes of failure Actions & Outcome Identify root causes of failure
also makes good business sense in a health modes Measures modes
care environment that is increasingly facing (P X Da X De) (P X Da) x K X De, Bands
6 REDESIGN THE PROCESS CALCULATE TOTAL RPN
demands from consumers, regulators & payers
7 Analyze & test the new process REDESIGN THE PROCESS
to create culture focused on reducing risk &
increasing accountability 8 Implement & monitor the Analyze & test the new process
redesigned process
Arjaty/ IMRK 33 Arjaty/ IMRK 35
9 Implement & monitor the
redesigned process

What is HFMEA ?
Modified by VA NCPS
Where did FMEA come from ?
 Focus on preventing defects, enhancing safety, increase
positive outcome and increase patient satisfaction
 FMEA has been around for over 30 years
 Recently gained widespread appeal  The objective is to look for all ways for process or product
outside of safety area can fail

 New to healthcare  The famous question : “What is could happen?” Not “What
 Frequently used reliability & system safety does happen ?”
analysis techniques
 Hybrid prospective analysis model combines concepts :
 Long industry track record FMEA (Failure Mode and Effects Analysis)
HACCP (Hazard Analysis Critical Control Points)
RCA (Root Cause Analysis)
Arjaty/ IMRK 34 Arjaty/ IMRK 36

HERKUTANTO, FMEA 2013 9

 LANGKAH-LANGKAH LANGKAH -LANGKAH
ANALISIS MODUS KEGAGALAN & DAMPAK (AMKD)® FAILURE MODE & EFFECT ANALYSIS
(HEALTHCARE FAILURE MODE EFFECT AND ANALYSIS)
(HFMEA)
By : VA NCPS 1. Pilih Proses yang berisiko tinggi dan Bentuk Tim
2. Gambarkan Alur Proses
3. Diskusikan Modus Kegagalan potensial dan Dampak
nya
1. Tetapkan Topik AMKD 4. Buat prioritas Modus Kegagalan yang akan
2. Bentuk Tim diintervensi
3. Gambarkan Alur Proses 5. Identifikasi Akar Penyebab Modus Kegagalan
4. Buat Hazard Analysis 6. Disain ulang proses / Re-disain Proses
5. Tindakan dan Pengukuran Outcome 7. Analisa & uji Proses baru
8. Implementasi & Monitor Proses baru
39

TIME LINE AND TEAM ACTIVITIES LANGKAH 1 : PILIH PROSES YANG BERISIKO TINGGI

Pilih Proses berisiko tinggi yang akan dianalisa.

Premeeting Identify Topic and notivy the team (Step 1 & 2)
1st team meeting Diagram the process, identify subprocess, verify the scope Judul Proses :
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) LANGKAH 2 : BENTUK TIM
4rd team meeting Identify failure modes causes, assign individual team members to
consult with process users for additional input (Step 3) Ketua :
____________________________________________________________
5th team meeting Transfer FM & Causes to the HFMEA Worksheet (Step3). Begin the
hazard analysis (Step 4) Anggota 1. _______________ 4.
Identify corrective actios and assign follow up responsibilities (Step 5) ________________________________________
2. _______________ 5.
6th,7th , 8th….η team Assign team members to follow up individual charged with taking ________________________________________
meeting plus 1 corrective action 3. _______________ 6.
________________________________________
η team meeting plus 2 Refine corrective actions based on feedback
η team meeting plus 3 Test the proposed changes Notulen? _________________________________________
η team meeting plus 4 Meet with Top Management to obtain approval for all actions Apakah semua Unit yang terkait dalam Proses sudah terwakili ? YA / TIDAK
Tanggal dimulai ____________________ Tanggal selesai ___________________
Postteam meeting The advisor or his/ her designee follow up until all actions are
completed
Arjaty/ IMRK 38 Arjaty/ IMRK 40

HERKUTANTO, FMEA 2013 10

 Arjaty/ IMRK 41 Arjaty/ IMRK 43

ANALISIS HAZARD “LEVEL DAMPAK”

DAMPA MINOR MODERAT MAYOR KATASTROPIK
K 1 2 3 4
Kegagalan yang tidak Kegagalan dapat Kegagalan menyebabkan Kegagalan menyebabkan
mengganggu Proses mempengaruhi proses kerugian berat kerugian besar
pelayanan kepada dan menimbulkan
Pasien kerugian ringan
Pasien Tidak ada cedera, Cedera ringan Cedera luas / berat  Kematian
Tidak ada Ada Perpanjangan Perpanjangan hari rawat  Kehilangan fungsi tubuh
perpanjangan hari rawat lebih lama (+> 1 bln) secara permanent (sensorik,
hari rawat Berkurangnya fungsi motorik, psikologik atau
permanen organ tubuh intelektual) mis :
(sensorik / motorik /  Operasi pada bagian atau
psikcologik / intelektual) pada pasien yang salah,
 Tertukarnya bayi

Pengunju Tidak ada cedera  Cedera ringan  Cedera luas / berat Kematian
ng Tidak ada penanganan  Ada Penanganan  Perlu dirawat Terjadipada > 6 orang
Terjadipada 1-2 org ringan  Terjadi pada 4 -6 pengunjung
pengunjung  Terjadi pada 2 -4 orang
pengunjung pengunjung
Staf: Tidak ada cedera Cedera ringan Cedera luas / berat Kematian
Tidak ada penanganan  Ada Penanganan /  Perlu dirawat Perawatan > 6 staf
Terjadipada 1-2 staf Tindakan Kehilangan waktu /
Tidak ada kerugian  Kehilangan waktu / kecelakaan kerja pada
waktu / keckerja kec kerja : 2-4 staf 4-6 staf
Fasilitas Kerugian < 1 000,,000 Kerugian Kerugian Kerugian > 50,000,000
Arjaty/ IMRK 42 Kes atau tanpa menimbulkan 1,000,000 - 10,000,000
Arjaty/ IMRK - 50,000,000 44
dampak terhadap pasien 10,000,000

HERKUTANTO, FMEA 2013 11

 ANALISIS HAZARD ”LEVEL PROBABILITAS”
LEVEL DESKRIPSI
4 Sering (Frequent)
3 Kadang-kadang
(Occasional)
2 Jarang (Uncommon)
1 Hampir Tidak Pernah Jarang sekali terjadi (dapat terjadi dalam
Decision Tree
Gunakan Decision Tree utk menentukan apakah modus perlu tindakan lanjut
CONTOH di“Proceed”..
Does this hazard involve a
Hampir sering muncul dalam waktu yang sufficient likelihood of
relative singkat (mungkin terjadi occurrence and severity to NO
warrant that it be
beberapa kali dalam 1 tahun) controlled?
(Hazard score of 8 or
higher) Is this a single point weakness in
NO
Kemungkinan akan muncul YES the process? (Criticality – failure
results in a system failure?)
(dapat terjadi bebearapa kali dalam 1 CRITICALY
sampai 2 tahun) YES
Does an effective control measure
YES
Kemungkinan akan muncul already exist for the identified hazard? STOP
CONTROL Do not proceed
(dapat terjadi dalam >2 sampai 5 tahun) to find potential
NO
causes for this
Is this hazard so obvious and readily
apparent that a control measure is not YES failure mode

(Remote) > 5 sampai 30 tahun) warranted?

DETECTABILITY Proceed to
NO Potential
Arjaty/ IMRK 45 Arjaty/ IMRK
Causes for 47
this failure
mode

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

Arjaty/ IMRK 46 Arjaty/ IMRK 48

HERKUTANTO, FMEA 2013 12

 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 49 Arjaty/ IMRK 51

STEP 2 DIAGRAM THE PROCESS

LANGKAH -LANGKAH PROCESS STEPS :
FAILURE MODE & EFFECT ANALYSIS 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

1. Pilih Proses yang berisiko tinggi dan Bentuk Tim

Prescribing, Preparing
2. Gambarkan Alur Proses Selection &
Procuremen
Storage
Ordering, & Administration
Trancribing Dispensin
t
3. Diskusikan Modus Kegagalan potensial dan Dampak g

nya
4. Buat prioritas Modus Kegagalan yang akan Failure Mode Failure Mode Failure Mode Failure Mode Failure Mode

diintervensi Pemesanan obat

Berlebihan (tdk
Penyimpanan
vaksin tdk
Penulisan obat
dlm R/ tdk jls
Peracikan obat
tdk sesuai dosis
Wrong drug

Sesuai kebthn) sesuai suhunya

5. Identifikasi Akar Penyebab Modus Kegagalan Wrong dosage

6. Disain ulang proses / Re-disain Proses Penulisan Obat R/

tdk R/
Dlm formularium Wrong frequence
7. Analisa & uji Proses baru
Wrong route
8. Implementasi & Monitor Proses baru administration

50 Arjaty/ IMRK 52

HERKUTANTO, FMEA 2013 13

 Arjaty/ IMRK 53 Herkutanto 2009

RATING SYSTEM
(Modified by IMRK)
HFMEA Rating Probabilitas DAMPAK Kontrol Deteksi
Proses lama
yg high risk (P) (D) (K) (D)
1 Remote Minor effect Easy Certain to detect
Alur
Potential Cause Efek / Decision Tindakan
Proses
Dampak Tree 2 Low likelihood Moderate effect Mpderate High likelihood
Failure K Easy
K
Mode HS
K 3 Moderate Minor injury Moderate Moderate
E
likelihood difficult likelihood
D
T 4 High likelihood Major injury Difficult Low likelihood
Desain Hazard
Proses baru Kritis Kontrol
Score Kontrol Eliminasi 5 Certain to Catastrophic effect Almost certain
Deteksi Terima
occur / terminal injury, not to detect
death

Risk Priority Number (RPN) / Criticaly Index (CI) = (Da x P) x K x De

Arjaty/ IMRK 54 Arjaty/ IMRK 56

HERKUTANTO, FMEA 2013 14

 Sample Severity Scale
Sample Detectability Scale
(Modified by IMRK)
(Modified by IMRK)
Rating Description Definition Rating Description Probability Definition
Minor effect or No effect May affect the individual served & would of
1
result in some effect on the process or Detection
Would not be noticeable to individual served Certain to 10 out to 10 Almost always detected
& would not affect the process
1
detect immediately
2 Moderate effect May affect the individual served & would 2 High likelihood 7 out of 10 Likely to be detected
result in a major effect on the process

3 Minor injury Would affect the individual and result in a

major effect on the process 3 Moderate 5 out of 10 Moderate likelihood of detection
likelihood
4 Major injury Would result in a major injury for the
individual served and have major effect on
4 Low likelihood 2 out 0f 10 Unlikely to be detected
the process
5 Catastrophic effect, a Extremely dangerous, failure would result
terminal injury or death death of the individual served and have a Almost certain 0 out of 10 Detection not possible at any point
major effect on the process 5
not to detect
Arjaty/ IMRK 57 Arjaty/ IMRK 59
Source : JCR : Joint Commision Resources

Sample Probability of Occurrence Scale

(Modified by IMRK)

Rating Description Probability Definition

1 Remote to 1 in 10,000 No or little known occurrence highly

non existent unlikely that condition will ever occur

2 Low 1 in 5000 Possible, but no known data, the

Likelihood condition occurs in isolated cases, but
chances are low
3 Moderate 1 in 200 Documented, but infrequently, the
likelihood condition has a reasonable chance to
occur
4 High 1 in 100 Documented and frequent, the
likelihood condition occurs very regularly and / or
during a reasonable amount of time

5 Certain to 1 in 20 Documented, almost certain, the

occur condition will inevitably occur during
long periods typical for the step or58link
Arjaty/ IMRK Arjaty/ IMRK 60

HERKUTANTO, FMEA 2013 15

 STEP 5 IDENTIFY ROOT CAUSES OF FAILURE MODES
Failure Mode Potential Potenti Severity Probabilit Ri Risk Control Detection RPN STEP 7 REDESIGN PROCESS
effect al y sk Catego (5X8X
causes Sc ries / 9)
or Bands Process Failure Potential Potential Redesign PIC Target New Outcome
e Mode Effect Causes Recommen Comple Process Measure /
(3 datio tio Implementa Monitoring
X4 ns n tion mechanism
) date date &
1 2 3 4 5 1 2 3 4 5 1- L M H E 1 2 3 4 1 2 3 4 5 for test Actions
25
1 2 3 4 5 6 7 8 9 10
Wrong route Death No X X 10 E X X 40 1 2 3 4 5 6 7 8 9
administratio Trainin
n g
Wrong Injury with No X X 12 E X X 24
frequency permanen record
t loss of in
function > Chart
Wrong No injury Miss X X 8 H X X 32
dosage with no read
permanen instruct
t loss of ion
function
Wrong drug No injury Miss X X 4 H X X 16
Arjaty/ IMRK 61 Arjaty/ IMRK 63
but LOS > identifi
cation

STEP 6 CALCULATE TOTAL RPN

PREPARING TO REDESIGN
No Failure RPN Potential RPN Potential RPN Total Rank
Mode Failure
Mode
effect effect Causes Causes RPN (step 6)
1 2 3 4 5 6 7 8 9

1 Wrong route 60 Death 40 No 40 1

 TAKE A DEEP BREATH
administrati Traini
140
on ng  Conduct a literature search to gather
2 Wrong
frequency
48 Injury with
permane
12 No record
in
24 84 3
relevant information from the professional
nt loss Chart
of literature. Do not reinvent the wheel
function

3 Wrong dosage 36 No injury 36 Miss read 32 104 2  Network with colleagues

with no instru

 Recommit to out of the box thinking

permane ction
nt loss
of
function

4 Wrong drug 36 No injury but 16 Miss 16 68 4

LOS > > identi
ficati
on
Arjaty/ IMRK 62 Arjaty/ IMRK 64

HERKUTANTO, FMEA 2013 16

 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

HERKUTANTO, FMEA 2013 17

 REDISAIN PROSES

 Variable input  Decreasing variability

 Simplify
 Complex
 Standardizing
 Nonstandarized  Loosen coupling of process
 Tightly Coupled  Use technology
 Dependent on human  Optimise Redundancy
intervention  Built in fail safe mechanism
 Time constraints  Documentation
 Establishing a culture of
 Hierarchical culture teamwork

Arjaty/ IMRK 71

LANGKAH 8
ANALISIS DAN UJI PROSES BARU
 The team again completes steps 2 (diagram the
process), step 3 (brainstorm potential failure
modes & determine their effect) and step 4
(prioritize failure modes) of the FMEA process
 Then the team should calculate a new criticality
index (CI) or RPN.
 Design improvements should bring reduction in
the CI / RPN.
Ex: 30 – 50% reduction ?

Arjaty/ IMRK 72

HERKUTANTO, FMEA 2013 18

 LANGKAH 9 AMKDP / HFMECA
IMPLEMENTASI DAN MONITORING PROSES
Total RPN Analisis &
Strategies for Creating & Managing the Change Process : PROSES Uji Proses Baru
LAMA Total RPN Implementasi
Prioritas Redisign PROSES
1. Establish a sense of urgency risiko BARU
PROSES BARU
 Failure Proses
2. Create a guiding coalition
Mode,  Failure
3. Develop a vision and strategy Mode,
 Dampak,
4. Communicate the changed vision  Dampak,
 Penyebab  Penyebab
5. Empower broad based action Total RPN
30-50%?
6. Generate short term wins
7. Consolidate gains and produce more change
8. Anchor new approaches in the culture

Arjaty/ IMRK 73 Arjaty/ IMRK 75

KESIMPULAN
AMKD / HFMEA Building a safe healthcare
Proses lama
yg high risk system
Alur
Potential Cause Efek / Decision Tindakan
Proses
Dampak Tree
Failure K
K
Mode HS
K
E
D
T
Desain Hazard
Proses baru Kritis Kontrol
Score Kontrol Eliminasi
Deteksi Terima

Arjaty/ IMRK 74
L E A D Arjaty/
EIMRKR S H I P 76

HERKUTANTO, FMEA 2013 19

 Safety begins with you
Don’t wait for someone else

Arjaty/ IMRK 77

HERKUTANTO, FMEA 2013 20