fmea kars-1

Dr Arjaty W Daud MARSDr Arjaty W Daud MARS

Arjaty/ IMRKArjaty/ IMRK 22

STRATEGI REDUKSI RISIKOSTRATEGI REDUKSI RISIKO IDENTIFIKASI PROSES YG RISIKO IDENTIFIKASI PROSES YG RISIKO

TINGGI TINGGI REDISAIN PROSES :REDISAIN PROSES : - FMEA- FMEA - AMKD- AMKD®® / HFMEA / HFMEA - AMKDP- AMKDP®® / HFMECA / HFMECA


RISK REDUCTION STRATEGIES DIFFICULTY & RISK REDUCTION STRATEGIES DIFFICULTY & LONG TERM EFFECTIVENESSLONG TERM EFFECTIVENESS

Types of actions Degree of Long term Types of actions Degree of Long term difficulty effectivenessdifficulty effectiveness

Easy LowEasy Low1.1. PunitivePunitive2.2. Retraining / counselingRetraining / counseling

3.3. Process redesignProcess redesign4.4. ““Paper vs practice”Paper vs practice”5.5. Technical system enhanceTechnical system enhance6.6. Culture changeCulture change

Difficult HighDifficult High


STRATEGI REDUKSI RISIKOSTRATEGI REDUKSI RISIKO

Identifikasi risiko dgn bertanya 3 pertanyaan dasar :Identifikasi risiko dgn bertanya 3 pertanyaan dasar : 1. Apa 1. Apa prosesnya prosesnya ?? 2. Dimana 2. Dimana “risk points” / “cause“risk points” / “cause”?”? 3. Apa yg dapat 3. Apa yg dapat “dimitigate”“dimitigate” pada dampak pada dampak “ “risk points” ?risk points” ?

Definisi ProsesTransformasi input menjadi output yg berkaitan dgn Kejadian, aktivitas dan mekanisme yg terstruktur


STRATEGI REDUKSI RISIKOSTRATEGI REDUKSI RISIKO

RENCANA REDUKSI RISIKO

Design Proses u/ Meminimalkan

risikokegagalan

Design Proses u/Mengurangi

DampakKegagalan terjadi

pada pasien

Design Proses u/ Meminimalkan

risikoKegagalan terjadi

Pada pasien

RISKPOINTS /

COMMON CAUSES


IDENTIFYING RISK PRONE SYSTEMIDENTIFYING RISK PRONE SYSTEM

Variable inputVariable inputComplex systemsComplex systemsNon standardized systems Non standardized systems Tightly coupled systemsTightly coupled systemsSystems with tight time constraintsSystems with tight time constraintsSystems with hierarchicalSystems with hierarchical


Variable inputPasien Penyakit berat Penyakit penyerta Pernah mendapatkan pengobatan Usia

Pemberi Pelayanan Tingkat keterampilan Cara pendekatan

Proses Pelayanan harus dapat mengakomodasi variabilitas yang tdk dapat dihindarkan dan tidak dapat dikontrol ini.


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%


Lack of Standardization Standard - --Standard - -- proses tidak dapat berjalan proses tidak dapat berjalan sesuai dengan harapansesuai dengan harapan Individu yang menjalankan proses harus Individu yang menjalankan proses harus

melaksanakan langkah langkah yang telah melaksanakan langkah langkah yang telah ditetapkan secara konsistenditetapkan secara konsisten

Variabilitas individual sangat tinggi -Variabilitas individual sangat tinggi - perlu standard mis : SPO, Parameter, Protokol, perlu standard mis : SPO, Parameter, Protokol,

Clinical Pathways Clinical Pathways dapat membatasi pengaruh dapat membatasi pengaruh dari variabel yang ada. dari variabel yang ada.


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


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


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.


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 TeknisResiden di MICU : ~ Ommission Suasana hierarki lebih datar ~ Kesalahan Pengambilan

Keputusan


What is FMEA ?What is FMEA ? Adalah metode perbaikan kinerja dgn Adalah metode perbaikan kinerja dgn

mengidentifikasi dan mencegah potensi mengidentifikasi dan mencegah potensi kegagalan sebelum terjadi. Hal tersebut kegagalan sebelum terjadi. Hal tersebut didesain untuk meningkatkan keselamatan didesain untuk meningkatkan keselamatan pasien. pasien.

Adalah proses proaktif, dimana kesalahan dpt Adalah proses proaktif, dimana kesalahan dpt dicegah & diprediksi. Mengantisipasi kesalahan dicegah & diprediksi. Mengantisipasi kesalahan akan meminimalkan dampak burukakan meminimalkan dampak buruk


FMEA TerminologyFMEA Terminology

Process FMEAProcess FMEA - Conduct an FMEA on a - Conduct an FMEA on a process that is already in placeprocess that is already in place

Design FMEADesign FMEA – Conduct an FMEA before – Conduct an FMEA before a process is put into placea process is put into place Implementing an electronic medical records or Implementing an electronic medical records or

other automated systemsother automated systemsPurchasing new equipmentPurchasing new equipmentRedesigning Emergency Room, Operating Redesigning Emergency Room, Operating

Room, Floor, etc.Room, Floor, etc.


FAILURE MODE AND EFFECTS ANALYSISFAILURE MODE AND EFFECTS ANALYSIS

FAILURE (F)FAILURE (F) : When a system or part of a system : When a system or part of a system performs in a way that is not performs in a way that is not intended or desirableintended or desirableMODE (M)MODE (M) : The way or manner in which : The way or manner in which something such as a failure can something such as a failure can happen. Failure mode is the happen. Failure mode is the manner in which something can manner in which something can fail.fail.EFFECTS (E)EFFECTS (E) : The results or consequences of a : The results or consequences of a failure modefailure modeAnalysis (A)Analysis (A) : The detailed examination of the : The detailed examination of the elements or structure of a processelements or structure of a process


Can prevent errors & nearmisses Can prevent errors & nearmisses protecting protecting patients from harm.patients from harm.

Can Can increase the effectiveness & efficiency of increase the effectiveness & efficiency of processprocess

Taking a proactive approach to patient safety Taking a proactive approach to patient safety also makes good business sense in a health also makes good business sense in a health care environment that is increasingly facing care environment that is increasingly facing demands from consumers, regulators & payers demands from consumers, regulators & payers to create culture focused on to create culture focused on reducing risk & reducing risk & increasing accountabilityincreasing accountability

Why should my organization Why should my organization conduct an FMEA ?conduct an FMEA ?


FMEA has been around for over 30 yearsFMEA has been around for over 30 yearsRecently gained widespread appeal Recently gained widespread appeal

outside of safety areaoutside of safety areaNew to healthcareNew to healthcare

Frequently used reliability & system safety Frequently used reliability & system safety analysis techniquesanalysis techniques

Long industry track recordLong industry track record

Where did FMEA come from ?Where did FMEA come from ?


FMEAOriginal

HFMEA By : VA NCPS

HFMECA®By IMRK

11 Select a high risk process & assemble a team

Define the HFMEA Topic

Select a high risk process & assemble a team

22 Diagram the process Assemble the Team Diagram the process

33 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

44 Prioritize failure modes Conduct a Hazard Analysis

Brainstorm potential effects of failure modes (P X Da) x K X De, Bands

55 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

66 REDESIGN THE PROCESS CALCULATE TOTAL RPN

77 Analyze & test the new process REDESIGN THE PROCESS

88 Implement & monitor the redesigned process

Analyze & test the new process

99 Implement & monitor the redesigned process

LANGKAH2 FMEA, HFMEA, HFMECA®LANGKAH2 FMEA, HFMEA, HFMECA®


What is HFMEA ?What is HFMEA ?Modified by VA NCPSModified 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 does happen ?”

Hybrid prospective analysis model combines concepts :

FMEA (Failure Mode and Effects Analysis) HACCP (Hazard Analysis Critical Control Points) RCA (Root Cause Analysis)

1. 1. Tetapkan Topik AMKD Tetapkan Topik AMKD 2. Bentuk Tim2. Bentuk Tim3. Gambarkan Alur Proses3. Gambarkan Alur Proses4. Buat Hazard Analysis4. Buat Hazard Analysis5. Tindakan dan Pengukuran Outcome5. Tindakan dan Pengukuran Outcome

LANGKAH-LANGKAHANALISIS MODUS KEGAGALAN & DAMPAK (AMKD)®

(HEALTHCARE FAILURE MODE EFFECT AND ANALYSIS) (HFMEA)

By : VA NCPS


HFMEA Components and Their OriginsHFMEA Components and Their OriginsConceptsConcepts HFMEAHFMEA FMEAFMEA HACCPHACCP RCARCA

Team membershipTeam membership VV VV VV

Diagramming Diagramming processprocess

VV VV VV

Failure mode & Failure mode & causescauses

VV VV

Hazard Scoring Hazard Scoring MatrixMatrix

VV VV

Severity & Probability Severity & Probability DefinitionsDefinitions

VV ## VV

Decision TreeDecision Tree VV VV

Actions & OutcomesActions & Outcomes VV ## VV

Responsible person Responsible person & management & management concurrenceconcurrence

VV ## VV

HACCP : Hazard Analysis Critical Control Point


TIME LINE AND TEAM ACTIVITIES

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….η team meeting plus 1

Assign team members to follow up individual charged with taking corrective action

η team meeting plus 2 Refine corrective actions based on feedback

η team meeting plus 3 Test the proposed changes

η 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


LANGKAH 1 : PILIH PROSES YANG BERISIKO TINGGILANGKAH 1 : PILIH PROSES YANG BERISIKO TINGGI

Pilih Proses berisiko tinggi yang akan dianalisa. Pilih Proses berisiko tinggi yang akan dianalisa.

Judul Proses :Judul Proses :________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________LANGKAH 2 : BENTUK TIMLANGKAH 2 : BENTUK TIM

Ketua : Ketua : ________________________________________________________________________________________________________________________

Anggota 1. _______________ Anggota 1. _______________ 4. 4. ________________________________________________________________________________

2. _______________ 5. 2. _______________ 5. ________________________________________ ________________________________________

3. _______________ 6. 3. _______________ 6. ________________________________________________________________________________

Notulen?Notulen? __________________________________________________________________________________Apakah semua Unit yang terkait dalam Proses sudah terwakili ?Apakah semua Unit yang terkait dalam Proses sudah terwakili ? YA / TIDAKYA / TIDAKTanggal dimulai ____________________ Tanggal selesai ___________________Tanggal dimulai ____________________ Tanggal selesai ___________________


ANALISIS HAZARD “LEVEL DAMPAK”ANALISIS HAZARD “LEVEL DAMPAK”DAMPADAMPA

KKMINOR MINOR

11MODERAT MODERAT

22MAYOR

3KATASTROPIK

4

Kegagalan yang tidak Kegagalan yang tidak mengganggu Proses mengganggu Proses pelayanan kepada pelayanan kepada PasienPasien

Kegagalan dapat Kegagalan dapat mempengaruhi proses mempengaruhi proses dan menimbulkan dan menimbulkan kerugian ringankerugian ringan

Kegagalan menyebabkan kerugian berat

Kegagalan menyebabkan kerugian besar

Pasien Pasien Tidak ada cedera,Tidak ada cedera,Tidak ada Tidak ada perpanjangan perpanjangan hari rawat hari rawat

Cedera ringan Cedera ringan Ada Perpanjangan Ada Perpanjangan hari rawat hari rawat

Cedera luas / beratPerpanjangan 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

PengunjuPengunjungng

Tidak ada cederaTidak ada cederaTidak ada penangananTidak ada penangananTerjadi pada 1-2 org Terjadi pada 1-2 org pengunjungpengunjung

Cedera ringan Cedera ringan Ada Penanganan Ada Penanganan ringanringan Terjadi pada 2 -4Terjadi pada 2 -4 pengunjungpengunjung

Cedera luas / berat Perlu dirawat Terjadi pada 4 -6 orang pengunjung

Kematian Terjadi pada > 6 orang pengunjung

Staf:Staf: Tidak ada cederaTidak ada cederaTidak ada penangananTidak ada penangananTerjadi pada 1-2 stafTerjadi pada 1-2 stafTidak ada kerugian Tidak ada kerugian waktu / keckerjawaktu / keckerja

Cedera ringan Cedera ringan Ada Penanganan / Ada Penanganan / TindakanTindakan KKehilangan waktu / ehilangan waktu / kec kerja kec kerja : 2-4 staf: 2-4 staf

Cedera luas / berat Perlu dirawat Kehilangan waktu / kecelakaan kerja pada 4-6 staf

KematianPerawatan > 6 staf

Fasilitas Fasilitas KesKes

Kerugian < 1 000,,000 Kerugian < 1 000,,000 atau tanpa atau tanpa menimbulkan dampak menimbulkan dampak terhadap pasienterhadap pasien

Kerugian Kerugian 1,000,000 - 1,000,000 - 10,000,00010,000,000

Kerugian 10,000,000 - 50,000,000

Kerugian > 50,000,000


ANALISIS ANALISIS HAZARDHAZARD ”LEVEL PROBABILITAS” ”LEVEL PROBABILITAS”

LEVELLEVEL DESKRIPSIDESKRIPSI CONTOH CONTOH

44 Sering Sering (Frequent)(Frequent) Hampir sering muncul dalam waktu yang Hampir sering muncul dalam waktu yang relative singkat (mungkin terjadi relative singkat (mungkin terjadi beberapa kali dalam 1 tahun)beberapa kali dalam 1 tahun)

33 Kadang-kadang Kadang-kadang (Occasional)(Occasional)

Kemungkinan akan muncul Kemungkinan akan muncul (dapat terjadi bebearapa kali dalam 1 (dapat terjadi bebearapa kali dalam 1

sampai 2 tahun)sampai 2 tahun)

22 Jarang Jarang (Uncommon)(Uncommon) Kemungkinan akan muncul Kemungkinan akan muncul (dapat terjadi dalam >2 sampai 5 tahun)(dapat terjadi dalam >2 sampai 5 tahun)

11 Hampir Tidak Pernah Hampir Tidak Pernah (Remote)(Remote)

Jarang sekali terjadi (dapat terjadi dalam Jarang sekali terjadi (dapat terjadi dalam > 5 sampai 30 tahun)> 5 sampai 30 tahun)


TINGKAT BAHAYATINGKAT BAHAYA

KATASTROPIKKATASTROPIK44

MAYORMAYOR33

MODERAT MODERAT 22

MINORMINOR11

SERINGSERING44

1616 1212 88 44

KADANGKADANG33

1212 99 66 33

JARANGJARANG22

88 66 44 22

HAMPIR TIDAK HAMPIR TIDAK PERNAHPERNAH

11

44 33 22 11

HAZARD SCORE


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 potentialcauses for this failure mode

Decision TreeDecision Tree Gunakan Decision Tree utk menentukan apakah modus perlu tindakan lanjut

di“Proceed”..


What is HFMECA®

Prospective analysis model combines Prospective analysis model combines concepts :concepts :

FMEA (Failure Mode and Effects Analysis)FMEA (Failure Mode and Effects Analysis) RCA (Root Cause Analysis)RCA (Root Cause Analysis)

Modified by IMRK :Modified by IMRK :Brainstorming : Failure mode, Effect, CausesBrainstorming : Failure mode, Effect, Causes

(Da X P) x(Da X P) x KK X De,X De, BandsBands


LANGKAH -LANGKAHANALISIS MODUS KEGAGALAN, DAMPAK & PENYEBAB

(AMKDP)®/HEALTHCARE FAILURE MODE EFFECT & CAUSES

ANALYSYS (HFMECA)®

1. Pilih Proses yang berisiko tinggi dan Bentuk Tim

2. Gambarkan Alur Proses3. Diskusikan & Prioritaskan Modus Kegagalan4. Brainstorming Dampak Modus Kegagalan5. Identifikasi Penyebab Modus Kegagalan 6. Hitung Total NPR (Nilai Prioritas Risiko) / RPN7. Disain ulang proses / Re-disain Proses8. Analisa & uji Proses baru9. Implementasi & Monitor Proses baru


LANGKAH 1 : LANGKAH 1 : PILIH PROSES YANG BERISIKO TINGGI & BENTUK TIMPILIH PROSES YANG BERISIKO TINGGI & BENTUK TIM

Pilih Proses berisiko tinggi yang akan dianalisa. Pilih Proses berisiko tinggi yang akan dianalisa.

Judul Proses : ___________________________________________Judul Proses : ___________________________________________

BENTUK TIMBENTUK TIM

Ketua : Ketua : ________________________________________________________________________________________________________________________

Anggota 1. _______________ Anggota 1. _______________ 4. 4. ________________________________________________________________________________

2. _______________ 5. 2. _______________ 5. ________________________________________ ________________________________________

3. _______________ 6. 3. _______________ 6. ________________________________________________________________________________

NotulenNotulen __________________________________________________________________________________Apakah semua Unit yang terkait dalam Proses sudah terwakili ?Apakah semua Unit yang terkait dalam Proses sudah terwakili ? YA / TIDAKYA / TIDAKTanggal dimulai _________________ Tanggal selesai _______________________Tanggal dimulai _________________ Tanggal selesai _______________________


STEP 2 DIAGRAM THE PROCESSSTEP 2 DIAGRAM THE PROCESSPROCESS STEPS :PROCESS STEPS :Describe the process graphically, according to your policy & procedure for the activity and number each oneDescribe the process graphically, according to your policy & procedure for the activity and number each oneIf the process is complex you may want to select one process step or sub process to work on 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 2 3 4 5

Failure Mode Failure Mode Failure Mode Failure Mode Failure ModeFailure Mode Failure Mode Failure Mode Failure Mode Failure Mode

Pemesanan obat Penyimpanan Penulisan obat Peracikan obat Wrong drugPemesanan obat Penyimpanan Penulisan obat Peracikan obat Wrong drug Berlebihan (tdk vaksin tdk dlm R/ tdk jls tdk sesuai dosis Berlebihan (tdk vaksin tdk dlm R/ tdk jls tdk sesuai dosis Sesuai kebthn)Sesuai kebthn) sesuai suhunya sesuai suhunya Wrong dosage Wrong dosage Penulisan Penulisan Obat R/ Obat R/ tdk tdk R/ R/ Dlm formularium Wrong frequence Dlm formularium Wrong frequence Wrong routeWrong route administrationadministration

Selection & Procurement

Storage Prescribing,Ordering,

Trancribing

Preparing &

Dispensing

Administration


Administering

Failure points where medication errors occurFailure points where medication errors occur

TranscribingPrescribing Dispensing

39% 12% 11% 38%J AMA 1995 J ul 5,274(1):29-34


RATING SYSTEM(Modified by IMRK)

Rating Probabilitas (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

Almost certain not to detect

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


Sample Severity Scale(Modified by IMRK)

Rating Description Definition1 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

2 Moderate effect May affect the individual served & would result in a major effect on the process

3 Minor injury Would affect the individual and result in a major effect on the process

4 Major injury Would result in a major injury for the individual served and have major effect on the process

5 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

Source : JCR : Joint Commision Resources


Rating Description Probability Definition

1 Remote to non existent

1 in 10,000 No or little known occurrence highly unlikely that condition will ever occur

2 Low Likelihood

1 in 5000 Possible, but no known data, the condition occurs in isolated cases, but chances are low

3 Moderate likelihood

1 in 200 Documented, but infrequently, the condition has a reasonable chance to occur

4 High likelihood

1 in 100 Documented and frequent, the condition occurs very regularly and / or during a reasonable amount of time

5 Certain to occur

1 in 20 Documented, almost certain, the condition will inevitably occur during long periods typical for the step or link

Sample Probability of Occurrence Scale(Modified by IMRK)


Sample Detectability Scale(Modified by IMRK)

RatingRating DescriptionDescription Probability Probability ofof

DetectionDetection

DefinitionDefinition

11 Certain to Certain to detectdetect

10 out to 1010 out to 10 Almost always detected Almost always detected immediatelyimmediately

22 High likelihoodHigh likelihood 7 out of 107 out of 10 Likely to be detectedLikely to be detected

33 Moderate Moderate likelihoodlikelihood

5 out of 105 out of 10 Moderate likelihood of detectionModerate likelihood of detection

4 Low likelihood 2 out 0f 10 Unlikely to be detected

55 Almost certain Almost certain not to detectnot to detect

0 out of 100 out of 10 Detection not possible at any pointDetection not possible at any point


CONTROLLABILITY

Controls and Status are unknown or Residual riskDifficult4

Controls are either not practically in place not effective, not communicated and or not complied with no reviews undertaken orControls can be introduced to reduce risk to an acceptable level but will take longer than 1 year or entail significant effort or expensive

Moderate difficult

3

Sufficient effective controls procedures are substantially in place for specific circumstances, communicated & are complied with periodic reviews are conducted orControls can be introduced to reduce risk to an acceptable levelwithin 1 year – or at cost

Moderate easy

2

Comprehensive effective controls fully in place, communicated, complied with, maintained, monitored, reviewed & tested regularly. All that is practicable to be done is being done orRisk can be introduced 1 month / or low cost or

Easy1

DefinitionDesriptionRating


STEP 5 IDENTIFY ROOT CAUSES OF FAILURE MODES Failure Mode Potential

effectPotent

ial cause

s

Severity Probability

Risk Score(3X4)

Risk Categor

ies / Bands

Control Detection RPN(5X8X

9)

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 10Wrong route administration

Death No Training

X X 10 E X X 40

Wrong frequency

Injury with permanent loss of function >

No record in Chart

X X 12 E X X 24

Wrong dosage

No injury with no permanent loss of function

Miss read instruction

X X 8 H X X 32

Wrong drug No injury but LOS >

Miss identification

X X 4 H X X 16


STEP 6 CALCULATE TOTAL RPNSTEP 6 CALCULATE TOTAL RPNNo Failure

ModeRPN

FailureMode

Potential effect

RPNeffect

PotentialCauses

RPNCauses

TotalRPN

Rank

1 2 3 4 5 6 7 8 9

1 Wrong route administration

60 Death 40 No Training

40 140 1

2 Wrong frequency

48 Injury with permanent loss of function

12 No record in Chart

24 84 3

3 Wrong dosage 36 No injury with no permanent loss of function

36 Miss read instruction

32 104 2

4 Wrong drug 36 No injury but LOS > >

16 Miss identification

16 68 4


STEP 7 REDESIGN PROCESSSTEP 7 REDESIGN PROCESS Process Failure

ModePotential

EffectPotential Causes

Redesign Recommen

dations

PIC Target Comple

tion

date for test

NewProcess

Implementation

date & Actions

Outcome Measure / Monitoring mechanism

1 2 3 4 5 6 7 8 9


TAKE A DEEP BREATHTAKE A DEEP BREATHConduct a literature search to Conduct a literature search to gather gather

relevant information from the professional relevant information from the professional literatureliterature. Do not reinvent the wheel. Do not reinvent the wheel

Network with colleaguesNetwork with colleaguesRecommit to out of the box thinkingRecommit to out of the box thinking

PREPARING TO REDESIGNPREPARING TO REDESIGN


LANGKAH 8ANALISIS 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 ?


LANGKAH 9LANGKAH 9IMPLEMENTASI DAN MONITORING PROSESIMPLEMENTASI DAN MONITORING PROSES

Strategies for Creating & Managing the Change Process :Strategies for Creating & Managing the Change Process :1.1. Establish a sense of urgencyEstablish a sense of urgency2.2. Create a guiding coalitionCreate a guiding coalition3.3. Develop a vision and strategyDevelop a vision and strategy4.4. Communicate the changed visionCommunicate the changed vision5.5. Empower broad based actionEmpower broad based action6.6. Generate short term winsGenerate short term wins7.7. Consolidate gains and produce more changeConsolidate gains and produce more change8.8. Anchor new approaches in the cultureAnchor new approaches in the culture


REDISAIN PROSESREDISAIN PROSES

Variable inputVariable input ComplexComplex NonstandarizedNonstandarized Tightly CoupledTightly Coupled Dependent on Dependent on

human interventionhuman intervention Time constraintsTime constraints Hierarchical cultureHierarchical culture

Decreasing variabilityDecreasing variability SimplifySimplify Standardizing Standardizing Loosen coupling of process Loosen coupling of process Use technologyUse technology Optimise RedundancyOptimise Redundancy Built in fail safe mechanismBuilt in fail safe mechanism DocumentationDocumentation Establishing a culture of Establishing a culture of

teamworkteamwork


Proses lama yg high risk

Desain Proses baru

AlurProses Potential Cause

FailureMode HS

Efek /Dampak

Decision Tree

KK

DT

K

E

Tindakan

AMKD / HFMEA

KontrolEliminasiTerima

KritisKontrolDeteksi

HazardScore


AMKDP / HFMECA

Prioritas Prioritas risikorisiko

Total RPN Total RPN PROSES PROSES LAMALAMA

FailureFailure Mode,Mode, Dampak, Dampak, PenyebabPenyebab

RedisignRedisignProsesProses

Analisis &Analisis & Uji Proses Uji Proses

Baru Total Baru Total RPN RPN

PROSES PROSES BARU BARU

FailureFailure Mode,Mode, Dampak, Dampak, PenyebabPenyebab

Implementasi Implementasi PROSES BARUPROSES BARU

Total RPN30-50%?


KESIMPULANKESIMPULANBuilding a safe Building a safe healthcare systemhealthcare system

DETEKSI

KONTROL

SEVERITY

FREKUENSI

LEARNING

RE

PO

RT

IN

G

ANALISIS

KOMUNIKASI

CU

LT

UR

E

TRAINING

TE

AM

WO

RK

L E A D E R S H I P


Safety begins with youDon’t wait for someone else

fmea kars-1

Documents

dimana risk points cause

arjaty imrkarjaty imrk

dampak risk points

lainperawat enggan bertanya

perlu standard mis

improvisasi bersifat

menghadapi risiko kegagalan