Вы находитесь на странице: 1из 19

F -X C h a n ge

F -X C h a n ge

c u -tr a c k

N
y
bu
to
k
lic
.d o

.c

.d o

lic

to

bu

O
W
!

PD

O
W
!

PD

c u -tr a c k

TUJUAN PAPARAN
Strategi Pengendalian
Risiko melalui HVA,
ICRA, FMEA
Mengenal langkah2
Failure Mode and
Effect Analysis

Failure Mode and Effect Analysis

Herkutanto

STRATEGI REDUKSI RISIKO


HAZARD AND VULNERABILITY
ASSESSMENT
Infection control rsik assesment
REDISAIN PROSES :
- FMEA
Arjaty/ IMRK

Herkutanto 2009

HERKUTANTO, FMEA 2013

.c

F -X C h a n ge

F -X C h a n ge

c u -tr a c k

N
y
bu
to
k
lic
.d o

.c

.d o

lic

to

bu

O
W
!

PD

O
W
!

PD

c u -tr a c k

The Purpose of the HVA

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
may be required. This is an organization
decision

STRATEGI PENGENDALIAN RISIKO DI


RUMAH SAKIT

OSHA Training Institute

Is this required?

Hazard and
Vulnerability
Assessment

The Joint Commission, previously called the


Joint 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

OSHA Training Institute Region IX


University of California, San Diego (UCSD) - Extension

OSHA Training Institute

HERKUTANTO, FMEA 2013

OSHA Training Institute

.c

F -X C h a n ge

F -X C h a n ge

c u -tr a c k

N
y
bu
to
k
lic

Preparedness

Kaiser model also includes:


Probability
Response factors
Human, property and business impacts, each
considered as a separate issue

Status of current plans


Training
Insurance
Back up systems
Community resources
9

11

OSHA Training Institute

A Comparison of Threat Events


Considered in HVA Models

Models
There are a number of models for an HVA.
Two well known models are from

ASHE Model 2001

American Society of Healthcare Engineering (ASHE)


Kaiser Foundation

OSHA Training Institute

Kaiser Foundation
Model 2001

Human Events
Natural Events
Technological Events

Both models can be adjusted to fit the


organization
Security organizations and other vendors also
market HVA tools

HERKUTANTO, FMEA 2013

c u -tr a c k

Medical Center HVA Model

Preparedness of the organizations ability


to manage risks, can include items such
as:

OSHA Training Institute

.d o

.c

.d o

lic

to

bu

O
W
!

PD

O
W
!

PD

10

OSHA Training Institute

Human Events
Natural Events
Technological Events
Hazmat Events

12

.c

F -X C h a n ge

F -X C h a n ge

c u -tr a c k

N
y
bu
to
k
lic
.d o

.c

.d o

lic

to

bu

O
W
!

PD

O
W
!

PD

c u -tr a c k

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

HERKUTANTO, FMEA 2013

OSHA Training Institute

13

OSHA Training Institute

15

OSHA Training Institute

14

OSHA Training Institute

16

.c

F -X C h a n ge

F -X C h a n ge

c u -tr a c k

N
y
bu
to
k
lic
.d o

.c

.d o

lic

to

bu

O
W
!

PD

O
W
!

PD

c u -tr a c k

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

RISK REDUCTION STRATEGIES DIFFICULTY &


LONG TERM EFFECTIVENESS
Types of actions

Long term
effectiveness

Easy

Low

2.

3.

Process redesign

4.

Paper vs practice
Technical system enhance
Culture change

5.
6.

HERKUTANTO, FMEA 2013

RISK
POINTS /
COMMON CAUSES

RENCANA
REDUKSI RISIKO

Difficult
Arjaty/ IMRK

STRATEGI REDUKSI RISIKO

Degree of
difficulty

Punitive
Retraining / counseling

1.

19

17

OSHA Training Institute

High
18

Design Proses u/
Meminimalkan
risiko
Kegagalan terjadi
Arjaty/ IMRK Pada pasien

Design Proses u/
Meminimalkan
risiko
kegagalan

Design Proses u/
Mengurangi
Dampak
Kegagalan terjadi
20
pada pasien

.c

F -X C h a n ge

F -X C h a n ge

c u -tr a c k

N
y
bu
to
k
lic

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%

Variable input
Complex systems
Non standardized systems
Tightly coupled systems
Systems with tight time constraints
Systems with hierarchical

21

Variable input

23

Standard - --

Pemberi Pelayanan
Tingkat keterampilan
Cara pendekatan
Proses Pelayanan harus dapat mengakomodasi
variabilitas yang tdk dapat dihindarkan dan tidak dapat
dikontrol ini.

HERKUTANTO, FMEA 2013

Arjaty/ IMRK

Lack of Standardization

Pasien
Penyakit berat
Penyakit penyerta
Pernah mendapatkan pengobatan
Usia

Arjaty/ IMRK

c u -tr a c k

Complexitas

IDENTIFYING RISK PRONE SYSTEM

Arjaty/ IMRK

.d o

.c

.d o

lic

to

bu

O
W
!

PD

O
W
!

PD

22

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.

Arjaty/ IMRK

24

.c

F -X C h a n ge

F -X C h a n ge

c u -tr a c k

N
y
bu
to
k
lic
c u -tr a c k

Hierarchical culture

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

.d o

.c

.d o

lic

to

bu

O
W
!

PD

O
W
!

PD

25

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
Arjaty/ IMRK
pelayanan kesehatan sangat
menentukan hasilnya.

27

Tightly Coupled
Perpindahan langkah dari suatu proses sering sangat
ketat, kadang baru disadari terjadi penyimpangan
pada langkah yang telah lanjut.
Keterlambatan dalam suatu langkah akan
mengakibatkan gangguan pada seluruh proses
Kekeliruan dalam suatu langkah akan mengakibatkan
penyimpangan pada langkah berikut ( cascade of
faillure )
Kesalahan biasanya terjadi pada saat perpindahan
langkah atau adanya langkah yang terabaikan
Arjaty/ IMRK

HERKUTANTO, FMEA 2013

26

Implementing Safety Cultures in Medicine:


What We Learn by Watching Physicians
Timothy J. Hoff, Henry Pohl, Joel Bartfield

Residen di Kamar Bedah : ~ Commission


~ Suasana hierarki tinggi
~ Kesalahan Teknis
Residen di MICU
: ~ Ommission
Suasana hierarki lebih datar
~ Kesalahan Pengambilan
Keputusan

Arjaty/ IMRK

28

.c

F -X C h a n ge

F -X C h a n ge

c u -tr a c k

N
y
bu
to
k
lic
.d o

.c

.d o

lic

to

bu

O
W
!

PD

O
W
!

PD

c u -tr a c k

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.

PENDEKATAN MELALUI FMEA

Arjaty/ IMRK

What is FMEA ?

FAILURE MODE AND EFFECTS ANALYSIS

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

31

30

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
Arjaty/ IMRK

32

.c

F -X C h a n ge

F -X C h a n ge

c u -tr a c k

N
y
bu
to
k
lic
.d o

.c

.d o

lic

to

bu

O
W
!

PD

O
W
!

PD

c u -tr a c k

LANGKAH2 FMEA, HFMEA, HFMECA

Why should my organization


conduct an FMEA ?

FMEA
Original

Can prevent errors & nearmisses


protecting
patients from harm.
Can increase the effectiveness & efficiency of
process
Taking a proactive approach to patient safety
also 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
Arjaty/ IMRK

HFMEA
By : VA NCPS

HFMECA
By IMRK

Select a high risk process &


assemble a team

Define the HFMEA


Topic

Select a high risk process &


assemble a team

Diagram the process

Assemble the Team

Diagram the process

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

Prioritize failure modes

Conduct a Hazard
Analysis

Brainstorm potential effects of


failure modes
(P X Da) x K X De, Bands

Identify 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

REDESIGN THE PROCESS

Analyze & test the new process

Implement & monitor the


redesigned process

33

CALCULATE TOTAL RPN


REDESIGN THE PROCESS
Analyze & test the new process
Arjaty/ IMRK

35

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
outside of safety area
New to healthcare

The objective is to look for all ways for process or product


can fail
The famous question : What is could happen? Not What
does happen ?

Frequently used reliability & system safety


analysis techniques

Hybrid prospective analysis model combines concepts :

Long industry track record

Arjaty/ IMRK

HERKUTANTO, FMEA 2013

FMEA (Failure Mode and Effects Analysis)


HACCP (Hazard Analysis Critical Control Points)
RCA
(Root Cause Analysis)
34

Arjaty/ IMRK

36

.c

F -X C h a n ge

F -X C h a n ge

c u -tr a c k

N
y
bu
to
k
lic

LANGKAH-LANGKAH
ANALISIS MODUS KEGAGALAN & DAMPAK (AMKD)
(HEALTHCARE FAILURE MODE EFFECT AND ANALYSIS)
(HFMEA)
By : VA NCPS

1.

3.
4.

2. Bentuk Tim
3. Gambarkan Alur Proses
4. Buat Hazard Analysis
5. Tindakan dan Pengukuran Outcome

c u -tr a c k

LANGKAH -LANGKAH
FAILURE MODE & EFFECT ANALYSIS

2.

1. Tetapkan Topik AMKD

.d o

.c

.d o

lic

to

bu

O
W
!

PD

O
W
!

PD

5.
6.
7.
8.

Pilih Proses yang berisiko tinggi dan Bentuk Tim


Gambarkan Alur Proses
Diskusikan Modus Kegagalan potensial dan Dampak
nya
Buat prioritas Modus Kegagalan yang akan
diintervensi
Identifikasi Akar Penyebab Modus Kegagalan
Disain ulang proses / Re-disain Proses
Analisa & uji Proses baru
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

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


meeting plus 1

_________________________________________________________
_________________________________________________________
LANGKAH 2 : BENTUK TIM
Ketua
:
____________________________________________________________

Assign team members to follow up individual charged with taking


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

Judul Proses :
__________________________________________________________________________

Anggota
1. _______________
4.
________________________________________
2. _______________
5.
________________________________________
3. _______________
6.
________________________________________
Notulen? _________________________________________
Apakah semua Unit yang terkait dalam Proses sudah terwakili ?
YA / TIDAK
Tanggal dimulai ____________________ Tanggal selesai ___________________

The advisor or his/ her designee follow up until all actions are
completed
Arjaty/ IMRK

HERKUTANTO, FMEA 2013

38

Arjaty/ IMRK

40

10

.c

F -X C h a n ge

F -X C h a n ge

c u -tr a c k

N
y
bu
to
k
lic
Arjaty/ IMRK

41

Arjaty/ IMRK

ANALISIS
DAMPA
K

MINOR
1
Kegagalan yang tidak
mengganggu Proses
pelayanan kepada
Pasien

Arjaty/ IMRK

42

.d o

m
o

.c

HERKUTANTO, FMEA 2013

.d o

lic

to

bu

O
W
!

PD

O
W
!

PD

c u -tr a c k

43

HAZARD LEVEL DAMPAK


MODERAT
2

MAYOR
3

Kegagalan dapat
mempengaruhi proses
dan menimbulkan
kerugian ringan

Kegagalan menyebabkan
kerugian berat

KATASTROPIK
4
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 org
pengunjung

Cedera ringan
Ada Penanganan
ringan
Terjadi pada 2 -4
pengunjung

Cedera luas / berat


Perlu dirawat
Terjadi pada 4 -6
orang
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

Fasilitas
Kes

Kerugian < 1 000,,000


atau tanpa menimbulkan
dampak terhadap pasien

Kerugian
1,000,000 10,000,000

Cedera luas / berat


Perlu dirawat
Kehilangan waktu /
kecelakaan kerja pada
4-6 staf
Kerugian

10,000,000
Arjaty/ IMRK

Kematian
Perawatan > 6 staf

Kerugian > 50,000,000


- 50,000,000

44

11

.c

F -X C h a n ge

F -X C h a n ge

c u -tr a c k

N
y
bu
to
k
lic

2
1

DESKRIPSI

Gunakan Decision Tree utk menentukan apakah modus perlu tindakan lanjut
diProceed..

CONTOH

Sering (Frequent)

Hampir sering muncul dalam waktu yang


relative singkat (mungkin terjadi
beberapa kali dalam 1 tahun)

Kemungkinan akan muncul


(dapat terjadi bebearapa kali dalam 1
sampai 2 tahun)

Kadang-kadang
(Occasional)
Jarang (Uncommon)

c u -tr a c k

Decision Tree

ANALISIS HAZARD LEVEL PROBABILITAS


LEVEL

.d o

.c

.d o

lic

to

bu

O
W
!

PD

O
W
!

PD

Kemungkinan akan muncul


(dapat terjadi dalam >2 sampai 5 tahun)

Hampir Tidak Pernah Jarang sekali terjadi (dapat terjadi dalam


(Remote)
> 5 sampai 30 tahun)
Arjaty/ IMRK

45

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

Is this a single point weakness in


the process? (Criticality failure
results in a system failure?)
CRITICALY
YES
Does an effective control measure
already exist for the identified hazard?
CONTROL
NO
Is this hazard so obvious and readily
apparent that a control measure is not
warranted?
DETECTABILITY
NO
Arjaty/ IMRK

NO

YES

STOP

YES

Proceed to
Potential
Causes for
this failure
mode

Do not proceed
to find potential
causes for this
failure mode

47

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

Arjaty/ IMRK

HERKUTANTO, FMEA 2013

46

Arjaty/ IMRK

48

12

.c

F -X C h a n ge

F -X C h a n ge

c u -tr a c k

N
y
bu
to
k
lic
.d o

.c

.d o

lic

to

bu

O
W
!

PD

O
W
!

PD

c u -tr a c k

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

STEP 2

LANGKAH -LANGKAH
FAILURE MODE & EFFECT ANALYSIS

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

1.
2.

3.
4.
5.
6.
7.
8.

Pilih Proses yang berisiko tinggi dan Bentuk Tim


Gambarkan Alur Proses
Diskusikan Modus Kegagalan potensial dan Dampak
nya
Buat prioritas Modus Kegagalan yang akan
diintervensi
Identifikasi Akar Penyebab Modus Kegagalan
Disain ulang proses / Re-disain Proses
Analisa & uji Proses baru
Implementasi & Monitor Proses baru
50

HERKUTANTO, FMEA 2013

51

Selection &
Procuremen
t

Failure Mode
Pemesanan obat
Berlebihan (tdk
Sesuai kebthn)

Storage

Failure Mode
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

Arjaty/ IMRK

52

13

.c

F -X C h a n ge

F -X C h a n ge

c u -tr a c k

N
y
bu
to
k
lic
Arjaty/ IMRK

RATING SYSTEM
(Modified by IMRK)

HFMEA
Potential Cause
Failure
Mode

c u -tr a c k

Herkutanto 2009

53

Rating

Probabilitas
(P)

DAMPAK
(D)

Kontrol
(K)

Deteksi
(D)

Remote

Minor effect

Easy

Certain to detect

Low likelihood

Moderate effect

Mpderate
Easy

High likelihood

Moderate
likelihood

Minor injury

Moderate
difficult

Moderate
likelihood

High likelihood

Major injury

Difficult

Low likelihood

Kontrol
Eliminasi
Terima

Certain to
occur

Catastrophic effect
/ terminal injury,
death

Proses lama
yg high risk
Alur
Proses

.d o

.c

.d o

lic

to

bu

O
W
!

PD

O
W
!

PD

Efek /
Dampak
HS

Decision
Tree
K
K

Tindakan
K
E

D
Desain
Proses baru

Hazard
Score

Kritis
Kontrol
Deteksi

Almost certain
not to detect

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


Arjaty/ IMRK

HERKUTANTO, FMEA 2013

54

Arjaty/ IMRK

56

14

.c

F -X C h a n ge

F -X C h a n ge

c u -tr a c k

N
y
bu
to
k
lic

Sample Severity Scale

c u -tr a c k

Sample Detectability Scale

(Modified by IMRK)

(Modified by IMRK)

Rating

Description

Definition

Rating

Minor effect or No effect

May affect the individual served & would


result in some effect on the process or
Would not be noticeable to individual served
& would not affect the process

Certain to
detect

10 out to 10

Almost always detected


immediately

High likelihood

7 out of 10

Likely to be detected

Description

Definition

Probability
of
Detection

Moderate effect

May affect the individual served & would


result in a major effect on the process

Minor injury

Would affect the individual and result in a


major effect on the process

5 out of 10

Moderate likelihood of detection

Major injury

Would result in a major injury for the


individual served and have major effect on
the process

Moderate
likelihood

Low likelihood

2 out 0f 10

Unlikely to be detected

Catastrophic effect, a
terminal injury or death

Extremely dangerous, failure would result


death of the individual served and have a
major effect on the process

Almost certain
not to detect

0 out of 10

Detection not possible at any point

Arjaty/ IMRK

Source : JCR : Joint Commision Resources

.d o

.c

.d o

lic

to

bu

O
W
!

PD

O
W
!

PD

57

Arjaty/ IMRK

59

Arjaty/ IMRK

60

Sample Probability of Occurrence Scale


(Modified by IMRK)
Rating

Description

Probability

Definition

Remote to
non existent

1 in 10,000

No or little known occurrence highly


unlikely that condition will ever occur

Low
Likelihood

1 in 5000

Possible, but no known data, the


condition occurs in isolated cases, but
chances are low

Moderate
likelihood

1 in 200

Documented, but infrequently, the


condition has a reasonable chance to
occur

High
likelihood

1 in 100

Documented and frequent, the


condition occurs very regularly and / or
during a reasonable amount of time

Certain to
occur

1 in 20

HERKUTANTO, FMEA 2013

Documented, almost certain, the


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

15

.c

F -X C h a n ge

F -X C h a n ge

c u -tr a c k

N
y
bu
to
k
lic
.d o

.c

.d o

lic

to

bu

O
W
!

PD

O
W
!

PD

c u -tr a c k

STEP 5 IDENTIFY ROOT CAUSES OF FAILURE MODES


Failure Mode

Potential
effect

Potenti
al
causes

Severity

Probabilit
y

Ri
sk
Sc
or
e
(3
X4
)

Risk
Catego
ries /
Bands

Control

STEP 7 REDESIGN PROCESS

RPN
(5X8X
9)

Detection

Process

Failure
Mode

Potential
Effect

Potential
Causes

Redesign
Recommen
datio
ns

PIC

Target
Comple
tio
n
date
for test

New
Process
Implementa
tion
date &
Actions

Outcome
Measure /
Monitoring
mechanism

1 2 3 4 5 1 2 3 4 5 1- L M H E 1 2 3 4 1 2 3 4 5
25
1

Wrong route
administratio
n

Death

No
Trainin
g

Wrong
frequency

Injury with
permanen
t loss of
function >

No
record
in
Chart

Wrong
dosage

No injury
with no
permanen
t loss of
function

Miss
read
instruct
ion

Wrong drug

No injury
but LOS >

Miss
identifi
cation

Arjaty/ IMRK

10

12

10

40

24

32

16

61

STEP 6 CALCULATE TOTAL RPN


No

Failure
Mode

RPN
Failure
Mode

Potential
effect

RPN
effect

Potential
Causes

RPN
Causes

Total
RPN

Rank

Wrong route
administrati
on

60

40

140

Wrong
frequency

48

Injury with
permane
nt loss
of
function

12

No record
in
Chart

24

84

Wrong dosage

36

No injury
with no
permane
nt loss
of
function

36

Miss read
instru
ction

32

104

Wrong drug

36

No injury but
LOS > >

16

Miss
identi
ficati
on

16

68

Death

40

No
Traini
ng

Arjaty/ IMRK

HERKUTANTO, FMEA 2013

62

Arjaty/ IMRK

63

PREPARING TO REDESIGN
(step 6)
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

Arjaty/ IMRK

64

16

.c

F -X C h a n ge

F -X C h a n ge

c u -tr a c k

N
y
bu
to
k
lic
.d o

.c

.d o

lic

to

bu

O
W
!

PD

O
W
!

PD

c u -tr a c k

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

HERKUTANTO, FMEA 2013

65

17

.c

F -X C h a n ge

F -X C h a n ge

c u -tr a c k

N
y
bu
to
k
lic
.d o

.c

.d o

lic

to

bu

O
W
!

PD

O
W
!

PD

c u -tr a c k

REDISAIN PROSES

Decreasing variability
Simplify
Standardizing
Loosen coupling of process
Use technology
Optimise Redundancy
Built in fail safe mechanism
Documentation
Establishing a culture of
teamwork

Variable input
Complex
Nonstandarized
Tightly Coupled
Dependent on human
intervention
Time constraints
Hierarchical culture
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

HERKUTANTO, FMEA 2013

72

18

.c

F -X C h a n ge

F -X C h a n ge

c u -tr a c k

N
y
bu
to
k
lic

Prioritas
risiko

Penyebab

73

Failure
Mode

Analisis &
Uji Proses Baru
Total RPN
PROSES
BARU

Implementasi
PROSES BARU

Failure
Mode,
Dampak,
Penyebab
Total RPN
30-50%?

Arjaty/ IMRK

75

KESIMPULAN
Building a safe healthcare
system

Proses lama
yg high risk
Potential Cause

Failure

Redisign
Proses

Dampak,

AMKD / HFMEA
Alur
Proses

Total RPN
PROSES
LAMA
Mode,

Arjaty/ IMRK

c u -tr a c k

AMKDP / HFMECA

LANGKAH 9
IMPLEMENTASI DAN MONITORING PROSES
Strategies for Creating & Managing the Change Process :
1.
Establish a sense of urgency
2.
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

.d o

.c

.d o

lic

to

bu

O
W
!

PD

O
W
!

PD

Efek /
Dampak

Decision
Tree

HS

K
K

Tindakan
K
E

D
T
Desain
Proses baru

Hazard
Score

Arjaty/ IMRK

HERKUTANTO, FMEA 2013

Kritis
Kontrol
Deteksi

Kontrol
Eliminasi
Terima

74

L E A D Arjaty/
EIMRKR S H I P

76

19

.c

Вам также может понравиться