F -X C h a n ge F -X C h a n ge

PD PD

!
W

W
O

O
N

N
y

y
bu

bu
to

to
k

k
lic

lic
C

C
w

w
m

m
w w
w

w
o

o
.d o .c .d o .c
c u -tr a c k c u -tr a c k

Herkutanto

KETUA KOMITE KESELAMATAN PASIEN

KETUA KONSIL KEDOKTERAN, KKI
Failure Mode and Effect Analysis Guru Besar Fakultas Kedokteran Universitas Indonesia

Herkutanto

ALASAN UTAMA MELAKUKAN REGULASI

TUJUAN PAPARAN
Strategi
Pengendalian Risiko
melalui FMEA

Mengenal langkah2
Failure Mode and
Effect Analysis
(Schellekens, W : Patient Safety Conference,
European Union Presidency Luxembourg, 4 – 5 April 2005)

HERKUTANTO, FMEA 1
 F -X C h a n ge F -X C h a n ge
PD PD

!
W

W
O

O
N

N
y

y
bu

bu
to

to
k

k
lic

lic
C

C
w

w
m

m
w w
w

w
o

o
.d o .c .d o .c
c u -tr a c k c u -tr a c k

INTRODUKSI FMEA & HFMEA

Herkutanto 2009

What is FMEA ? What is HFMEA ?

Adalah metode perbaikan kinerja dgn
mengidentifikasi dan mencegah potensi
kegagalan sebelum terjadi. Hal tersebut
didesain untuk meningkatkan keselamatan
pasien.
Modified by VA NCPS
Focus on preventing defects, enhancing safety, increase
positive outcome and increase patient satisfaction
The objective is to look for all ways for process or product
can fail

The famous question : “What is could happen?” Not “What

Adalah proses proaktif, dimana kesalahan does happen ?”
dpt dicegah & diprediksi. Mengantisipasi
Hybrid prospective analysis model combines concepts :
kesalahan akan meminimalkan dampak buruk FMEA (Failure Mode and Effects Analysis)
HACCP (Hazard Analysis Critical Control Points)
RCA (Root Cause Analysis)
7 8

HERKUTANTO, FMEA 2
 F -X C h a n ge F -X C h a n ge
PD PD

!
W

W
O

O
N

N
y

y
bu

bu
to

to
k

k
lic

lic
C

C
w

w
m

m
w w
w

w
o

o
.d o .c .d o .c
c u -tr a c k c u -tr a c k

FAILURE MODE AND EFFECTS ANALYSIS

FMEA Terminology
Process FMEA - Conduct an FMEA on a
process that is already in place
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.
9 10
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

Why should my organization

Where did FMEA come from ?
conduct an FMEA ?
Can prevent errors & nearmisses protecting FMEA has been around for over 30 years
patients from harm.
Recently gained widespread appeal
Can increase the effectiveness & efficiency of
outside of safety area
process
Taking a proactive approach to patient safety New to healthcare
also makes good business sense in a health Frequently used reliability & system safety
care environment that is increasingly facing analysis techniques
demands from consumers, regulators & payers Long industry track record
to create culture focused on reducing risk &
increasing accountability
11 12

HERKUTANTO, FMEA 3
 F -X C h a n ge F -X C h a n ge
PD PD

!
W

W
O

O
N

N
y

y
bu

bu
to

to
k

k
lic

lic
C

C
w

w
m

m
w w
w

w
o

o
.d o .c .d o .c
c u -tr a c k c u -tr a c k

FMEA HFMEA LANGKAH-LANGKAH

General By : VA NCPS
ANALISIS MODUS KEGAGALAN & DAMPAK (AMKD)®
1 Select a high risk process & Define the HFMEA Topic
assemble a team
(HEALTHCARE FAILURE MODE EFFECT AND ANALYSIS)
2 Diagram the process Assemble the Team
(HFMEA)
3 Brainstorm potential failure modes &
By : VA NCPS
Graphically describe the Process
determine their effects
(P X Da X De)
4 Prioritize failure modes Conduct a Hazard Analysis

1. Tetapkan Topik AMKD

5 Identify root causes of failure modes Actions & Outcome Measures
(P X Da X De) (Redesign)
2. Bentuk Tim
3. Gambarkan Alur Proses
6 REDESIGN THE PROCESS
4. Buat Hazard Analysis
7 Analyze & test the new process
5. Tindakan dan Pengukuran Outcome
8 Implement & monitor the redesigned
process
9 13

HFMEA
Tetapkan Tetapkan
Potential
Hazard
Efek /
Dampak
Decision
Tree
Tindakan 1
Pilih Proses Rumuskan
Failure K
yang berisiko Alur K
Mode HS
tinggi Proses K
E
D
T
Hazard
Kritis Kontrol
Score Kontrol Eliminasi
Deteksi Terima
TETAPKAN TOPIK

Desain
15
Proses baru

HERKUTANTO, FMEA 4
 F -X C h a n ge F -X C h a n ge
PD PD

!
W

W
O

O
N

N
y

y
bu

bu
to

to
k

k
lic

lic
C

C
w

w
m

m
w w
w

w
o

o
.d o .c .d o .c
c u -tr a c k c u -tr a c k

PEMILIHAN TOPIK FMEA TUJUAN PEMILIHAN TOPIK

Proses spesifik di rumah sakit: Fokus pada proses spesifik yang dianggap
Highrisk prioritas (hospital specific)
Highvolume Melakukan tindakan korektif pada proses
highcost melalui redesign proses
Didasarkan pada data incident report Contoh:
keselamatan pasien Proses pelayanan Transfusi darah
Data rutin keselamatan pasien Proses pemberian obat kepada pasien
Sentinel event

Arjaty/ IMRK 17 18

Characteristic of a high risk process

Variable team

Complex
2
Non standardized

Tightly coupled

Heavily dependent on human intervention

Hierarchical vs team
BENTUK TIM FMEA
Tight time constraints

Loose time constraints

HERKUTANTO, FMEA 5
 F -X C h a n ge F -X C h a n ge
PD PD

!
W

W
O

O
N

N
y

y
bu

bu
to

to
k

k
lic

lic
C

C
w

w
m

m
w w
w

w
o

o
.d o .c .d o .c
c u -tr a c k c u -tr a c k
LANGKAH 1 : PILIH PROSES YANG BERISIKO TINGGI TIME LINE AND TEAM ACTIVITIES
Pilih Proses berisiko tinggi yang akan dianalisa.
Premeeting Identify Topic and notivy the team (Step 1 & 2)
Judul Proses : 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
LANGKAH 2 : BENTUK TIM consult with process users (Step 3)
4rd team meeting Identify failure modes causes, assign individual team members to
Ketua : consult with process users for additional input (Step 3)
____________________________________________________________
5th team meeting Transfer FM & Causes to the HFMEA Worksheet (Step3). Begin the
Anggota 1. _______________ 4. hazard analysis (Step 4)
________________________________________ Identify corrective actios and assign follow up responsibilities (Step 5)
2. _______________ 5.
________________________________________ 6th,7th , 8th…. team Assign team members to follow up individual charged with taking
3. _______________ 6. meeting plus 1 corrective action
________________________________________ team meeting plus 2 Refine corrective actions based on feedback
Notulen? _________________________________________ team meeting plus 3 Test the proposed changes
Apakah semua Unit yang terkait dalam Proses sudah terwakili ? YA / TIDAK team meeting plus 4 Meet with Top Management to obtain approval for all actions
Tanggal dimulai ____________________ Tanggal selesai ___________________
Postteam meeting The advisor or his/ her designee follow up until all actions are
completed
21 22

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

3 Selection &
Procuremen
Storage
Prescribing,
Ordering,
Trancribing
Preparing
&
Dispensin
Administration
t
g

Failure Mode Failure Mode Failure Mode Failure Mode Failure Mode

Pemesanan obat Penyimpanan Penulisan obat Peracikan obat Wrong drug

Berlebihan (tdk vaksin tdk dlm R/ tdk jls tdk sesuai dosis
Sesuai kebthn) sesuai suhunya
Wrong dosage

Penulisan Obat R/

GAMBAR ALUR PROSES tdk R/

Dlm formularium Wrong frequence

Wrong route
administration

24

HERKUTANTO, FMEA 6
 F -X C h a n ge F -X C h a n ge
PD PD

!
W

W
O

O
N

N
y

y
bu

bu
to

to
k

k
lic

lic
C

C
w

w
m

m
w w
w

w
o

o
.d o .c .d o .c
c u -tr a c k c u -tr a c k

Arjaty/ IMRK 25 Arjaty/ IMRK 26

Hazard analysis: What is it?

4 Hazard: Potentially dangerous condition,

which is triggered by an event, called the
cause of the hazard.

Risk: hazard that is associated with a

IDENTIFIKASI & ANALISIS severity and a probability of occurrence.
HAZARD

HERKUTANTO, FMEA 7
 F -X C h a n ge F -X C h a n ge
PD PD

!
W

W
O

O
N

N
y

y
bu

bu
to

to
k

k
lic

lic
C

C
w

w
m

m
w w
w

w
o

o
.d o .c .d o .c
c u -tr a c k c u -tr a c k

Hazard, Barrier, Target Analysis Hazard, Barrier, Target Analysis

Hazard Barrier Target Hazard Barrier Target

High Medical Policies

Dog Fence Child Procedures Patient
Mishaps

HERKUTANTO, FMEA 8
 F -X C h a n ge F -X C h a n ge
PD PD

!
W

W
O

O
N

N
y

y
bu

bu
to

to
k

k
lic

lic
C

C
w

w
m

m
w w
w

w
o

o
.d o .c .d o .c
c u -tr a c k c u -tr a c k

Arjaty/ IMRK 36

HERKUTANTO, FMEA 9
 F -X C h a n ge F -X C h a n ge
PD PD

!
W

W
O

O
N

N
y

y
bu

bu
to

to
k

k
lic

lic
C

C
w

w
m

m
w w
w

w
o

o
.d o .c .d o .c
c u -tr a c k c u -tr a c k
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 Terjadi pada > 6 orang
Terjadi pada 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
Terjadi pada 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 37 Kes atau tanpa menimbulkan 1,000,000 - 10,000,000
Arjaty/ IMRK - 50,000,000 38
dampak terhadap pasien 10,000,000

ANALISIS HAZARD ”LEVEL PROBABILITAS” HAZARD SCORE

LEVEL DESKRIPSI CONTOH TINGKAT BAHAYA
4 Sering (Frequent) Hampir sering muncul dalam waktu yang KATASTROPIK MAYOR MODERAT MINOR
relative singkat (mungkin terjadi 4 3 2 1
beberapa kali dalam 1 tahun)
SERING 16 12 8 4
4
3 Kadang-kadang Kemungkinan akan muncul
(Occasional) (dapat terjadi bebearapa kali dalam 1 KADANG 12 9 6 3
sampai 2 tahun) 3

2 Jarang (Uncommon) Kemungkinan akan muncul JARANG 8 6 4 2

(dapat terjadi dalam >2 sampai 5 tahun) 2

1 Hampir Tidak Pernah Jarang sekali terjadi (dapat terjadi dalam HAMPIR TIDAK 4 3 2 1
(Remote) > 5 sampai 30 tahun) PERNAH
1

39 40

HERKUTANTO, FMEA 10
 F -X C h a n ge F -X C h a n ge
PD PD

!
W

W
O

O
N

N
y

y
bu

bu
to

to
k

k
lic

lic
C

C
w

w
m

m
w w
w

w
o

o
.d o .c .d o .c
c u -tr a c k c u -tr a c k

Full Hazard Analysis Completed Hazards & Effects Register

Proactive Controls Reactive Controls

HAZARDS & EFFECTS REGISTER
Risk
Recovery Hazard ThreatsBarriers Top Recovery ConsequencesRating Initial Final Remedial
People
Threat Barrier Barrier Measures Event Measures Risk Risk Action
P A E R Required
Recovery Asset
Threat Barrier Barrier C5
Hazard Top Event Measures Damage X X X X X X X X X X D4,5 X
(Incident) E3,4,5
Recovery Environment
Threat Barrier Barrier Measures
X X X X X X X X
Recovery
Measures Reputation
Escalation C5
controls X X X X X X X X X X D4,5
E3,4,5

X X X X X X X X X

Arjaty/ IMRK 43 Arjaty/ IMRK 44

HERKUTANTO, FMEA 11
 F -X C h a n ge F -X C h a n ge
PD PD

!
W

W
O

O
N

N
y

y
bu

bu
to

to
k

k
lic

lic
C

C
w

w
m

m
w w
w

w
o

o
.d o .c .d o .c
c u -tr a c k c u -tr a c k

Decision Tree
Gunakan Decision Tree utk menentukan apakah modus perlu tindakan lanjut
di“Proceed”..
Does this hazard involve a

5 sufficient likelihood of
occurrence and severity to
warrant that it be
controlled?
NO

(Hazard score of 8 or
higher) Is this a single point weakness in
NO
YES the process? (Criticality – failure
results in a system failure?)
CRITICALY
YES
Does an effective control measure
YES
already exist for the identified hazard? STOP
CONTROL Do not proceed
NO to find potential
TINDAKAN & REDESIGN Is this hazard so obvious and readily
apparent that a control measure is not YES
causes for this
failure mode

warranted?
DETECTABILITY Proceed to
NO Potential
Causes for 46
this failure
mode

PREPARING TO REDESIGN REDESIGN STRATEGIES

Conduct a literature search to gather Prevent the failure from happening

relevant information from the professional
literature. Do not reinvent the wheel
Network with colleagues
Recommit to out of the box thinking
(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)

47 48

HERKUTANTO, FMEA 12
 F -X C h a n ge F -X C h a n ge
PD PD

!
W

W
O

O
N

N
y

y
bu

bu
to

to
k

k
lic

lic
C

C
w

w
m

m
w w
w

w
o

o
.d o .c .d o .c
c u -tr a c k c u -tr a c k

PROSES METODE REDESIGN PROCESS

RISIKO TINGGI REDESIGN Process Failure Potential Potential Redesign PIC Target New Outcome
Mode Effect Causes Recommen Complet Process Measure /
dations ion Implementa Monitoring
Variable input date tion mechanism
Decreasing variability for test date &
Complex Simplify
Actions

Nonstandarized Standardizing
Tightly Coupled Loosen coupling of process
1 2 3 4 5 6 7 8 9
Dependent on human Use technology
intervention Optimise Redundancy
Built in fail safe mechanism
Time constraints
Documentation
Hierarchical culture Establishing a culture of
teamwork

49 50

RESULT
Proses
Redesign

A New and more Safe Process

Bandingkan :

Improved policies & procedures

Analisis & Ranking Analisis & Ranking
Reliable & more safe Hospital
Failure Failure
Effect Causes Effect Causes
Mode Mode

Proses Lama Proses Baru

Arjaty/ IMRK 52

HERKUTANTO, FMEA 13
 F -X C h a n ge F -X C h a n ge
PD PD

!
W

W
O

O
N

N
y

y
bu

bu
to

to
k

k
lic

lic
C

C
w

w
m

m
w w
w

w
o

o
.d o .c .d o .c
c u -tr a c k c u -tr a c k

Herkutanto 2009

HERKUTANTO, FMEA 14