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  • 7/25/2019 Petunjuk 2 Materi Identifikasi Resiko

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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

    http://www.ashe.org/http://www.training.fema.gov/emiweb/EMICourses/E464http://www.docu-track.com/buy/http://www.docu-track.com/buy/http://www.training.fema.gov/emiweb/EMICourses/E464http://www.ashe.org/http://www.docu-track.com/buy/http://www.docu-track.com/buy/
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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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  • 7/25/2019 Petunjuk 2 Materi Identifikasi Resiko

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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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  • 7/25/2019 Petunjuk 2 Materi Identifikasi Resiko

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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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  • 7/25/2019 Petunjuk 2 Materi Identifikasi Resiko

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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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  • 7/25/2019 Petunjuk 2 Materi Identifikasi Resiko

    18/19

    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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  • 7/25/2019 Petunjuk 2 Materi Identifikasi Resiko

    19/19

    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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