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Failure Mode and Effect Analysis

Herkutanto

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Herkutanto

KETUA KOMITE KESELAMATAN PASIEN

KETUA KONSIL KEDOKTERAN, KKIGuru Besar Fakultas Kedokteran Universitas Indonesia

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(Schellekens, W : Patient Safety Conference,

European Union Presidency Luxembourg, 4–

5 April 2005)

ALASAN UTAMA MELAKUKAN REGULASI

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TUJUAN PAPARAN

Strategi

Pengendal ian Risiko

melalui

FMEA

Mengenal langkah

2

Failure Mode

andEffect Analysis

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KUALITAS PELAYANAN(Donabedian)

STRUCTURE

PROCESS

OUTCOME

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SUMBER

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SISTIMATIKA PAPARAN

INTRODUKSI FMEA

DELAPAN LANGKAH FMEA

KESIMPULAN

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INTRODUKSI FMEA & HFMEA

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What is FMEA ? Adalah metode perbaikan kinerja dgn

mengidentifikasi dan mencegah potensikegagalan sebelum terjadi. Hal tersebut

didesain untuk meningkatkan keselamatan

pasien.

Adalah proses proaktif, dimana kesalahan

dpt dicegah & diprediksi. Mengantisipasi

kesalahan akan meminimalkan dampak buruk

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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 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)

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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 orother automated systems

Purchasing new equipment

Redesigning Emergency Room, OperatingRoom, Floor, etc.

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FAILURE MODE AND EFFECTS ANALYSIS

FAILURE (F) : When asystem

orpart

of a systemper forms in a way that is not

intended or desirable

MODE (M) : The way or manner in which

something such as a fai lure canhappen . Failure mode is the

manner in which something can

fail.

EFFECTS (E) : The results or consequences of afai lure mode

Analysis (A) : The detailed examinat ion of the

elements or structure of a process

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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

Why should my organization

conduct an FMEA ?

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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 ?

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DELAPAN LANGKAH FMEA

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1. Tetapkan Topik FMEA dan Bentuk Tim

2. Gambarkan Alur Proses

3. Identifikas Modus Kegagalan & Dampak nya (Hazard Analysis)

4. Identifikas Prioritas Modus Kegagalan

5. Identifikasi Akar Penyebab Modus Kegagalan

6. Disain ulang Proses

7. Analisis dan Test Proses Baru

8. Implementasi dan Monitor Proses Baru

LANGKAH-LANGKAH

ANALISIS MODUS KEGAGALAN & DAMPAKNYA

(JCI )

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Output setiap langkah

LANGKAH OUTPUT

1 Tetapkan Topik FMEA dan Bentuk Tim Topik dan Tim

2 Gambarkan Alur Proses Alur Proses tergambar

3 Identifikasi Modus Kegagalan &

Dampaknya

Modus Kegagalan &

Dampaknya

4 Tetapkan Prioritas Modus Kegagalan Daftar Prioritas Modus

Kegagalan

5 Identifikasi Akar Penyebab Modus

Kegagalan

Akar Penyebab

Modus Kegagalan

6 Disain ulang Proses Proses Baru

7 Analisis dan Uji Coba Proses Baru Hasil Uji COba

8 Implementasi dan Monitor Proses Baru Penerapan Proses Baru

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TETAPKAN TOPIK & TIM

1

19

LANGKAH

1 Tetapkan Topik

FMEA dan Bentuk

Tim

2 Gambarkan Alur

Proses

3 Identifikasi Modus

Kegagalan &

Dampaknya

4 Tetapkan Prioritas

Modus Kegagalan

5 Identifikasi Akar

Penyebab Modus

Kegagalan

6 Disain ulang

Proses

7 Analisis dan Uji

Coba Proses

Baru

8 Implementasi dan

Monitor ProsesBaru

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TUJUAN & HASIL

Terpilihnya Topik FMEA

Terpilihnya TIM Pelaksana untuk topik

tersebut

Daftar Tim

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PEMILIHAN TOPIK FMEA

Proses spesifik di rumah sakit:

Highrisk

Highvolume

highcost

Didasarkan pada data incident report

keselamatan pasien

Data rutin keselamatan pasien

Sentinel event

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TUJUAN PEMILIHAN TOPIK

Fokus pada proses spesifik yang dianggap

prioritas (hospital specific )

Melakukan tindakan korektif pada proses

melalui redesign proses

Contoh:

Proses pelayanan Transfusi darah

Proses pemberian obat kepada pasien

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Characteristic of a high risk process

Variable team

Complex

Non standardized

Tightly coupled

Heavily dependent on human intervention

Hierarchical vs team

Tight time constraints

Loose time constraints 23HERKUTANTO

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24

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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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

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Gambarkan Alur Proses

2

26

LANGKAH

1 Tetapkan Topik

FMEA dan Bentuk

Tim

2 Gambarkan Alur

Proses


Kegagalan &

Dampaknya


Modus Kegagalan

5 Identifikasi Akar

Penyebab Modus

Kegagalan

6 Disain ulang

Proses7 Analisis dan Uji

Coba Proses

Baru

8 Implementasi dan

Monitor ProsesBaru

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TUJUAN & HASIL

Tergambarnya alur / langkah2 PROSES

dan SUBPROSES pelayanan yang dipilih

dalam suatu bagan yang jelas

LEMBAR ALUR

PROSES dan SUBPROSES PELAYANAN

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IdentifikasiModus Kegagalan &

Dampaknya

3

30

LANGKAH

1 Tetapkan TopikFMEA dan Bentuk

Tim

2 Gambarkan Alur

Proses

3 Identifikasi ModusKegagalan &

Dampaknya

4 Tetapkan PrioritasModus Kegagalan

5 Identifikasi AkarPenyebab Modus

Kegagalan

6 Disain ulang Proses

7 Analisis dan Uji CobaProses Baru

8 Implementasi danMonitor Proses Baru

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TUJUAN & HASIL

1. Teridentifikasinya MODUS KEGAGALAN

pada setiap langkah proses pelayanan

2. Teridentifikasinya DAMPAK KEGAGALAN

pada setiap langkah proses pelayanan

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HAZARD vs RISK vs.

COMPLICATIONS

1. A hazard is something that can cause harm, e.g. electricity, chemicals,

working up a ladder, noise, a keyboard, a bully at work, stress, etc. [...

tindakan medik ...??]

2. Complications are things that happen as a result of a dis ease or a

treatmentthat you prefer didn't happen [stroke from hypertension, orbleeding following surgery ]

A complication may be described as an adverse event caused by pre-

existing factors that were outside the doctor’s control . Patients are not thesame in health, habits, immunity or healing power, and have varying susceptibility

to complications

3. A risk is the chance, high or low, that any hazard wi l l actual ly causesomebody harm .

Risk factors are things that make it more likely that you will develop a

disease or condition. They may be things you can't do anything about ,

like gender, family history, or race, or things you can control , like smoking

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DIFFERENCES BETWEEN RISKS vs COMPLICATIONS

RISKS

Allergy

Leucocytosis

Bleeding

Fragile tissues

Naucea / vomit

COMPLICATIONS

Anaphylactic Rx

Sepsis

Hypovolemic shock

Tissue damage

Hyponatraemia

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Hazard analysis: What is it?

Hazard: Potentially dangerous condition,

which is t r iggered by an event ,

called the cause of the hazard .

Risk: hazard that is associated with a

severi ty and a probabi li ty ofoccurrence .

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Hazard, Barrier, Target Analysis

Barrier

Dog Child

Hazard Target

HighFence

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H d B i T t A l i

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Hazard, Barrier, Target Analysis

Barrier

MedicalMishaps

Patient

Hazard Target

PoliciesProcedures

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DIAGRAM THE PROCESS

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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

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/tdk R/

Dlm formularium Wrong frequence

Wrong route

administration

Selection &

Procurement

StoragePrescribing,

Ordering,

Trancribing

Preparing

&

Dispensin

g

Administration

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Hazard analysis: Identify all possible

hazards potentially created by a

product, process or application.

Risk assessment: It is the next step

after the collection of potential

hazards. Risk in this context is the

probability and severity of the hazard

becoming reality .44HERKUTANTO

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Document Results

Verify Effectiveness

Reduce Risks

Derive Risk Rating

Assess Risks

Identify Hazards

Establish Analysis Parameters

General risk assessment

protocol :

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Document Results


Reduce Risks

Derive Risk Rating

Assess Risks

Identify Hazards


These parameters can

be limits of themachine or design,

limits on uses, limits

on the scope of theanalysis, or other

limits.

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Document Results


Reduce Risks

Derive Risk Rating

Assess Risks

Identify Hazards


The nature of this

step lends itself to ateam approach such

as brainstorming.

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Document Results


Reduce Risks

Derive Risk Rating

Assess Risks

Identify Hazards


Two risk factors are used:• severity of injury

• probability of occurrenc

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Document Results


Reduce Risks

Derive Risk Rating

Assess Risks

Identify Hazards


Catastrophic Critical Marginal NegligibleFrequent High High Serious Serious

Probable High High Serious Low

Occasional High Serious Low Low

Remote Serious Low Low Low

Improbable Serious Low Low Low

Severity Category

Probability Level

Risk matrix:

If the risk is determined to not be acceptable, it

is necessary to reduce that risk by

implementing protective measures.

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Document Results


Reduce Risks

Derive Risk Rating

Assess Risks

Identify Hazards

Establish Analysis ParametersRemedy actions are taken to

reduce risks following the

hazard hierarchy:

• Eliminate hazards through the design

Protect

Warn the user

Train the user(s)

Personal protective equipment

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Document Results


Reduce Risks

Derive Risk Rating

Assess Risks

Identify Hazards


This assessment

verifies that theremedy actions have

reduced the risks to an

acceptable level.

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Document Results


Reduce Risks

Derive Risk Rating

Assess Risks

Identify Hazards


The documentation can be added to atechnical file for future use.

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Full Hazard Analysis

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Full Hazard Analysis

Hazard Top Event

(Incident)

Asset

Damage

People

Environment

Reputation

Threat

Threat

Threat

Barrier

BarrierBarrier

BarrierBarrier

Barrier

Recovery

Measures

Recovery

Measures

Recovery

Measures

Recovery

Measures

Escalationcontrols

Proactive Controls Reactive Controls

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Hazard Threats Barriers Top

Event

Recovery

MeasuresP A E R

Initial

Risk

Final

Risk

Risk

RatingRemedial

Action

Required

HAZARDS & EFFECTS REGISTER

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

C5

D4,5

E3,4,5

X

X

Consequences

X X X

C5D4,5

E3,4,5

X X X

X

X

X

X

X

X

Completed Hazards & Effects Register

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LANGKAH

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Tetapkan PrioritasModus Kegagalan

4

56

1 Tetapkan TopikFMEA dan Bentuk

Tim

2 Gambarkan Alur

Proses

3 Identifikasi ModusKegagalan &

Dampaknya

4 Tetapkan PrioritasModus Kegagalan

5 Identifikasi AkarPenyebab Modus

Kegagalan

6 Disain ulang Proses

7 Analisis dan Uji CobaProses Baru

8 Implementasi danMonitor Proses Baru

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TUJUAN & HASIL

Tersedianya urutan prioritas

DAFTAR PRIORITAS MODUS

KEGAGALAN

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ANALISIS HAZARD “LEVEL DAMPAK”

DAMPA MINOR MODERAT MAYOR KATASTROPIK

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DAMPA

K

MINOR

1

MODERAT

2

MAYOR

3

KATASTROPIK

4

Kegagalan yang tidak

mengganggu Proses

pelayanan kepada

Pasien

Kegagalan dapat

mempengaruhi

proses dan

menimbulkankerugian 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

Pengunj

ung

Tidak ada cedera

Tidak ada penanganan

Terjadi pada 1-2 org

pengunjung

Cedera ringan

Ada Penangananringan

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

Cedera ringan

Ada Penanganan /

Tindakan

Kehilangan waktu-

Cedera luas / berat

Perlu dirawat

Kehilangan waktu /

kecelakaan kerja pada-

Kematian

Perawatan > 6 stafHERKUTANTO

ANALISIS HAZARD ”LEVEL PROBABILITAS”

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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)

HERKUTANTO

HAZARD SCORE

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TINGKAT BAHAYA

KATASTROPIK

4

MAYOR

3

MODERAT

2

MINOR

1

SERING

4 16 12 8 4

KADANG

3 12 9 6 3

JARANG

2 8 6 4 2

HAMPIR TIDAK

PERNAH

1

4 3 2 1

HAZARD SCORE

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Laboratory Test Order ing Process

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HERKUTANTO 64

LANGKAH

1 Tetapkan Topik

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Identifikasi Akar Penyebab

Modus Kegagalan

5

65

1 Tetapkan Topik

FMEA dan Bentuk

Tim

2 Gambarkan Alur

Proses


Kegagalan &

Dampaknya


Modus Kegagalan5 Identifikasi Akar

Penyebab Modus

Kegagalan

6 Disain ulang


Coba Proses

Baru

8 Implementasi dan

Monitor Proses

Baru

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TUJUAN & HASIL

Teridentifikasinya AKAR PENYEBAB

modus kegagalan yang telah teridentifikasi

Lembar AKAR PENYEBAB

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Possible Characteristics of Root

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Causes

Root causes are systemic.

Root causes appear far from the origin of

the failure.

The origins of root causes lie in common-

cause variation of organization systems

HERKUTANTO 67

many of the failure modes

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many of the failure modes

had the same root causes

Omission errors secondary to automatic stop order

Suboptimal patient involvement in medication histories

Suboptimal medication reconciliation by clinicians

Confusing epidural and patient-controlled analgesia

order sets

Lack of electronic medication administration record

Lack of computerized order entry

HERKUTANTO 68

PROBING

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PROBINGto unco ver root causes and thei r relat ionships

What could happen? (the fai lure mode )

Why could this happen?

That is, what are the most proximate causes? Thesetypically involve special-cause variations.

Why could these proximate causes happen?

That is, what systems and processes underlie thoseproximate causes?

Common-cause variation here may lead to special-

cause variation in dependent processes.HERKUTANTO 69

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Human factors

failure to follow policieson precaution orders or failure

to conduct appropriate staff education/training

Assessment process factors

faulty initial assessment process

Equipment factors nonfunctional paging system that delays

communication with the individual’s physician

HERKUTANTO 70

What cou ld happen? - FACTORS

Questions to Uncover Causes

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What safeguards are missing in the process?

If the process already contains safeguards (forexample, double checks), why might they not work to

prevent the failure every time?

What would have to go wrong for a failure likethis to happen?

If this failure occurred, why would the problem

not be identified before it affected an individual?

HERKUTANTO 71

Questions to Uncover Causes

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W h a t

c o u

l d

h a p p e

n ?

Contributory Factors to Suicide

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W h a t

c o u

l d

h a p p e

n ?

DIABETES SCREENING

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HERKUTANTO 74 W h a t c o u

l d

h a p p e n

?

Labo ratory Test

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Ordering Process

HERKUTANTO 75

LANGKAH

1 Tetapkan Topik

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Disain Ulang Proses

6

76

e ap a op

FMEA dan Bentuk

Tim

2 Gambarkan Alur

Proses3 Identifikasi Modus

Kegagalan &

Dampaknya



Penyebab Modus

Kegagalan

6 Disain ulang


Coba Proses

Baru

8 Implementasi dan

Monitor Proses

Baru

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TUJUAN & HASIL

Teridentifikasinya PROSES BARU yang

bebas dari modus kegagalan

Lembar langkah2 PROSES BARU

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Decision Tree

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Does this hazard involve a

sufficient likelihood ofoccurrence 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?)CRITICALITY

Does an effective control measure already exist

for the identified hazard?

CONTROL THE HAZARD (=BARRIER)

Is this hazard so obvious and readilyapparent that a control measure is not

warranted?

DETECTABILITY

(FORESEEABILITY)

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

Gunakan Decision Tree utk menentukan apakah modus perlu tindakan lanjut di“Proceed”

78HERKUTANTO

PREPARING TO REDESIGN

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79

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

HERKUTANTO

REDESIGN STRATEGIES

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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)

80HERKUTANTO

PROSES METODE

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81

Variable input Complex

Nonstandarized

Tightly Coupled

Dependent on human

intervention

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 ofteamwork

PROSES

RISIKO TINGGI

METODE

REDESIGN

HERKUTANTO

REDESIGN PROCESS

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82

Process Failure

Mode

Potential

Effect

Potential

Causes

Redesign

Recommend

ations

PIC Target

Completi

on

datefor test

New

Process

Implementat

iondate &

Actions

Outcome

Measure /

Monitoring

mechanism

1 2 3 4 5 6 7 8 9

HERKUTANTO

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Failure

ModeEffect Causes

Analisis & Ranking

Proses

Redesign

Failure

ModeEffect Causes

Analisis & Ranking

Bandingkan :

Proses Lama Proses Baru

83HERKUTANTO

LANGKAH

1 Tetapkan Topik

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Analisis dan Uji CobaProses Baru

7

84

FMEA dan Bentuk

Tim

2 Gambarkan Alur


Kegagalan &

Dampaknya



Penyebab Modus

Kegagalan

6 Disain ulang

Proses

7 Analisis dan Uji

Coba Proses

Baru

8 Implementasi dan

Monitor Proses

Baru

HERKUTANTO

TUJUAN & HASIL

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TUJUAN & HASIL

Terujinya PROSES BARU dilapangan

Le

85HERKUTANTO

SIKLUS PDSA

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SIKLUS PDSA

HERKUTANTO 86

SIKLUS PDSA

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SIKLUS PDSA

HERKUTANTO 87

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L E

M B A R

K E R J

A

U J I C

O B A

HERKUTANTO 88

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L E

M B A R

K E R J

A

U J I C

O B A

HERKUTANTO 89

LANGKAH

1 Tetapkan Topik

FMEA d B t k

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Implementasi & MonitorProses Baru

8

90

FMEA dan Bentuk

Tim

2 Gambarkan Alur


Kegagalan &

Dampaknya



Penyebab Modus

Kegagalan

6 Disain ulang

Proses

7 Analisis dan Uji

Coba Proses

Baru

8 Implementasi

dan Monitor

Proses Baru

HERKUTANTO

TUJUAN & HASIL

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TUJUAN & HASIL

PENERAPAN PROSES BARU

Manajemen Perubahan

Lembar MONITORING PROSES BARU

91HERKUTANTO

Strategies for Creating and Managing

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g g g g

the Change Process

Establish a sense of urgency

Create a guiding coalition

Develop a vision and strategy

Communicate the changed vision

Empower broad-based action

Generate short-term wins

Consolidate gains and produce more change

Anchor new approaches in the cultureHERKUTANTO 92

LEMBAR MONITOR PROSES BARU

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HERKUTANTO 93

•


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HERKUTANTO 94

KESIMPULAN

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KESIMPULAN

PROSES BARU YANG LEBIH AMAN

KEBIJAKAN & SOP LEBIH BAIK

RUMAH SAKIT YANG AMAN

95HERKUTANTO

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Documents

FMEA 2016