13. FMEA 2016-Penyuluhan Singkat.pdf

Failure Mode and Effect Analysis

Herkutanto

Herkutanto KETUA K ETUA KOMITE KESELAMATAN KESELAMATAN PASIEN KESELAMAT PASIEN K ETUA KON KETUA KONSIL SIL KEDOKTERAN, KEDOKTERAN KEDOK TERAN,, KKI Guru Besar Fak Guru Fakultas ultas Kedokteran Universitas Indonesia

HERKUTANTO

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Herkutanto KETUA K ETUA KOMITE KESELAMATAN KESELAMATAN PASIEN KESELAMAT PASIEN K ETUA KON KETUA KONSIL SIL KEDOKTERAN, KEDOKTERAN KEDOK TERAN,, KKI Guru Besar Fak Guru Fakultas ultas Kedokteran Universitas Indonesia

HERKUTANTO

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ALASAN UT UTAMA AMA MELAKUKAN REGULASI

(Schellekens, (Schellekens, W : Patient Safety Conference, European European Union Union Presidency Presidency Luxembou Luxembourg, rg, 4 – 5 April 2005) 2005)

TUJUAN PAPARAN S trateg i Peng endalian R is iko melalui FMEA

Meng enal lang kah 2 Failure Mode and Effect Analysis HERKUTANTO

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KUALITAS PELAYANAN (Donabedian)

OUTCOME

PROCESS PROCESS STRUCTURE

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SUMBER

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SISTIMATIKA PAPARAN 

INTRODUKSI FMEA



DELAPAN LANGKAH FMEA



KESIMPULAN HERKUTANTO

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INTRODUKSI FMEA & HFMEA HERKUTANTO

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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

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What is HFMEA ? Modified by VA NCPS 

Focus on preventing defects, enhancing safety, increase positive outcome and increase patient satisfaction



The objective is to look for all all ways for proces s can fail



“ 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 a process that is already in place



Design FMEA – 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. 

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FAILURE MODE AND EFFECTS ANALYSIS part of a system FAILURE (F) : When a s ys tem or part performs in a way that is not intended or desirable MODE (M) : The way or manner in which something such as a failure can appen. a ure mo e s e 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 proces s HERKUTANTO

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Why should my organization conduct an FMEA ? 

Can prevent errors & nearmisses 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 HERKUTANTO



protecting

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Where did FMEA come from ? 

FMEA has been around for over 30 years



Recently gained widespread appeal outside of safety area



ew o ea

care



Frequently used reliability & system safety analysis techniques



Long industry track record

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DELAPAN LANGKAH FMEA HERKUTANTO

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LANGKAH-LANGKAH LANGKAHANALISIS MODUS KEGAGALAN & DAMPAKNYA DAMPAKNYA ( JJ C I ( I )

1.

Tetapkan Topik FMEA Topik FMEA dan Bentuk Tim

2.

Gambarkan Alur Gambarkan Alur Proses

3.

Identifikas Modus Kegagalan & Dampak nya nya (Hazard Analysis)

4.

Identifikas Prioritas Modus Kegagalan Kegagalan

5.

Identifikasi Akar Identifikasi Akar Penyebab Modus Kegagalan Kegagalan

6.

Disain ulang Proses

7. 8.

Analisis dan Test Proses Baru Implementasi dan Monitor Proses Baru HERKUTANTO

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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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LANGKAH 1 Tetapkan Topik FMEA dan Bentuk Tim 2 Gambarkan Alur Proses 3 Identifikasi Modus Kegagalan & Dampaknya

1

4 Tetapkan Prioritas Modus Kegagalan 5 Identifikasi Akar Penyebab Modus Kegagalan

TETAPKAN TOPIK & TIM HERKUTANTO

6 Disain ulang Proses 7 Analisis dan Uji Coba Proses Baru 8 Implementasi dan 19 Monitor Proses Baru

TUJUAN & HASIL 

Terpilihnya Topik FMEA



tersebut 

Daftar Tim Daftar

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PEMILIHAN TOPIK FMEA 



Proses spesifik di rumah sakit: 

Highrisk



Highvolume

Didasarkan pada data incident report keselamatan pasien 

Data rutin keselamatan pasien 

Sentinel event HERKUTANTO

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TUJUAN PEMILIHAN TOPIK 

Fokus pada proses spesifik yang dianggap prioritas (hospital (hospital specific )



Melakukan tindakan korektif pada proses



Contoh: 

Proses pelayanan Transfusi darah



Proses pemberian obat kepada pasien

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Characteristic of of a high risk process 

Variable team



Complex



Non standardized

 

Heavily dependent on human intervention



Hierarchical vs team



Tight time constraints



Loose time constraints

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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 meetin

Transfer FM & Causes to the HFMEA Worksheet Ste 3 . Be in 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


Test the proposed changes


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 HERKUTANTO

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2


Gambarkan Alur Proses HERKUTANTO


TUJUAN & HASIL 

Tergambarnya alur / langkah2 PROSES dan SUBPROSES pelayanan yang dipilih a am sua u agan yang e as



LEMBAR ALUR PROSES dan SUBPROSES PELAYANAN ELAYANAN

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LANGKAH 1 Tetapkan Topik FMEA dan Bentuk Tim


3 Identifikasi Modus Kegagalan & Dampaknya

3

4 Tetapkan Prioritas Modus Ke a alan


Identifikasi Modus Kegagalan & Dampaknya HERKUTANTO

6 Disain ulang Proses 7 Analisis dan Uji Coba Proses Baru

8 Implementasi dan Monitor Proses31Baru

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, work, stress, etc. [... tindakan medik ...??] ...??]

result of a dis eas e or a 2. Complications Complications are things that happen as a result of treatment that you prefer didn’t happen [stroke from hypertension, hypertension, or 

A complication may be described as an adverse event caused by prepreexisting factors that were outside the doctors control . Patients are not the same 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 will actually caus e s omebody harm. 

R is k 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 or things you can control , like smoking and diet. HERKUTANTO 33

DIFFERENCES BETWEEN RISKS vs COMPLICATIONS

RISKS

COMPLICATIONS



Allergy



Anaphylactic Rx



Bleeding



Hypovolemic shock



Fragile tissues



Tissue damage



Naucea / vomit



Hyponatraemia

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Hazard analysis: What is it? Hazard: Potentially dangerous condition, which is trig g ered by an event , called the cause of the hazard . Risk: hazard that is associated with a s everity and a probability of occurrence. HERKUTANTO

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Hazard, Barrier, Target Analysis Hazard

Barrier

Target

Dog

High Fence

Child

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Hazard, Barrier, Target Analysis Hazard

Medical Mishaps

Barrier

Policies Procedures

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Target

Patient

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PENERAPAN HBA PADA FMEA 

Prinsip:: the DEVILS are in the DETAILS Prinsip



Cari modus / cara suatu langkah dalam sua u su proses apa gaga

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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

Selection & Procurement

Failure Mode Pemesanan obat Berlebihan (tdk Sesuai kebthn) kebthn)

2

Storage

Failure Mode Penyimpanan vaksin tdk sesuai suhunya

3

Prescribing, Ordering, Trancribing

Failure Mode Penulisan obat obat dlm R/ tdk jls

4

Preparing & Dispensin g

5

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

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Hazard analysis: What is it?

Hazard analysis: Identify Identify all all possible possible hazards potentially potentially created created by a , . Risk assessment assessment:: It It is the next next step after the collection of potential after potential hazards.. Risk in this context hazards context is the probability and probability and severity severity of of the hazard becoming reality . becoming HERKUTANTO

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Hazard analysis: What is it? General risk assessment Establish Analysis Parameters protocol : en y azar s

Assess Risks

Derive Risk Rating

Reduce Risks

Verify Effectiveness HERKUTANTO

Document Results

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Hazard analysis: What is it? Establish Analysis Parameters

Identify Hazards

Assess Risks

Derive Risk Rating

Reduce Risks

Verify Effectiveness

Document Results

These parameters can be limits of the machine or design, limits on uses, limits on the scope of the analysis, or other limits. HERKUTANTO

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Identify Hazards

Assess Risks

Derive Risk Rating

The nature of this step lends itself to a team approach such as brainstorming.

Reduce Risks


Document Results

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Identify Hazards

Assess Risks

Derive Risk Rating

Two risk factors are used: • severity of injury • probability of occurrenc

Reduce Risks


Document Results

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Risk matrix: Severity Category

Identify Hazards

Assess Risks

Derive Risk Rating

Reduce Risks


Document Results

Probability Level Catastrophic Critical

Marginal

Negligible

Frequent

High

High

Serious

Serious

Probable

High

High

Serious

Low

Occasional

High

Serious

Low

Low

Remote

Serious

Low

Low

Low

Improbable

Serious

Low

Low

Low

If the risk is determined to not be acceptable, it is necessary to reduce that risk by implementing protective measures. HERKUTANTO

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Remedy actions are taken to reduce risks following the hazard hierarchy:

Identify Hazards

Assess Risks

• Eliminate hazards through the design Derive Risk Rating

Reduce Risks

•

Protect

•

Warn the user

•

Train the user(s)

•

Personal protective equipment


Document Results

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Identify Hazards

Assess Risks

Derive Risk Rating

Reduce Risks

This assessment verifies that the remedy actions have reduced the risks to an acceptable level.


Document Results

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Identify Hazards

Assess Risks

Derive Risk Rating

Reduce Risks

The documentation can be added to a technical file for future use.


Document Results

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Full Hazard Analysis Proactive Controls

Threat

Hazard

Threat

Threat

Barrier

Barrier

Barrier

Reactive Controls

Barrier

Recovery Measures

People

Barrier

Recovery Measures

Asset Damage

Top Event

Barrier

Recovery Measures

Environment

Recovery Measures

Reputation

Escalation controls

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Completed Hazards & Effects Register

HAZARDS & EFFECTS REGISTER Risk Initial Final Remedial Hazard ThreatsBarriers Top Recovery Consequences Rating Event Measures Risk Risk Action Required P A E R X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

C5 X X X X D4,5 , ,

X

X X X X

X

C5 X X X X D4,5 E3,4,5

X HERKUTANTO

X X X X

X

X

X

X 55

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LANGKAH 1 Tetapkan Topik FMEA dan Bentuk Tim


3 Identifikasi Modus

4

Kegagalan & Dampaknya

4 Tetapkan Prioritas Modus Kegagalan


6 Disain ulang Proses

Tetapkan Prioritas Modus Kegagalan

7 Analisis dan Uji Coba Proses Baru

8 Implementasi dan HERKUTANTO

Monitor Proses Baru 57

TUJUAN & HASIL 

Tersedianya urutan prioritas



DAFTAR PRIORITAS MODUS KEGAGALAN

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ANALISIS DAMPA K

Pasien

MINOR 1

HAZARD “LEVEL DAMPAK” MODERAT 2

MAYOR 3

KATASTROPIK 4

Kegagalan yang tidak mengganggu Proses pelayanan kepada Pasien

Kegagalan dapat mempengaruhi proses dan menimbulkan kerugian ringan

Kegagalan menyebabkan kerugian berat

Kegagalan menyebabkan kerugian besar

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



(sensorik / motorik / psikcologik / intelektual)

pada pasien yang salah,  Tertukarnya bayi

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





Pengunj ung



Tidak ada cedera Tidak ada penanganan 1--2 org Terjadi pada 1 pengunjung



Staf:

Tidak ada cedera Tidak ada penanganan 1--2 staf Terjadi pada 1







Cedera ringan  Ada Penanganan ringan  Terjadi pada 2 -4 pengunjung



Cedera ringan Cedera luas / berat  Ada Penanganan /  Perlu dirawat HERKUTANTO Tindakan Kehilangan waktu / kecelakaan kerja pada  Kehilangan waktu -

Kematian  Kehilangan fungsi tubuh secara permanent (sensorik, motorik, psikologik atau intelektual) mis :

Kematian Terjadi pada > 6 orang pengunjung

Kematian Perawatan > 6 staf 

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ANALISIS HAZARD ”LEVEL PROBABILITAS” LEVEL

DESKRIPSI

4

Sering (Frequent) (Frequent)

3

Kadan -kadan (Occasional)

CONTOH

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

Kemun kinan kinan akan muncul (dapat terjadi bebearapa kali dalam 1 sampai 2 tahun)

2

Jarang (Uncommon) (Uncommon)

1

Hampir Tidak Pernah Jarang sekali terjadi (dapat terjadi dalam > 5 sampai 30 tahun) (Remote)

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

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HAZARD SCORE 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

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Laboratory Tes t Ordering Proces s

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5


Identifikasi Akar Penyebab Modus Kegagalan HERKUTANTO


TUJUAN & HASIL 

Teridentifikasinya AKAR PENYEBAB modus kegagalan yang telah teridentifikasi



Lembar AKAR Lembar AKAR PENYEBAB

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Possible Characteristics of Root Causes



Root causes are systemic. systemic .



oo causes appear ar rom the failure. failure.



The origins of root causes lie in common common-cause variation of organization systems HERKUTANTO

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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



Subo timal medication reconciliation b clinicians



Confusing epidural and patientpatient-controlled analgesia order sets



Lack of electronic medication administration record



Lack of computerized order entry HERKUTANTO

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PROBING to uncover root caus es and their relations hips 

What could happen? could happen? (the failure mode)



Why could this could this happen? 



That is, what are the most roximate causes? causes? These typically involve specialspecial-cause variations.

Why could these could these proximate causes happen? 

That is, what systems and processes underlie those proximate causes? causes?



Common-cause variation here may lead to specialCommonspecialcause variation in dependent processes. HERKUTANTO

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What could happen? - FACTORS 

Human factors 



Assessment process factors 



failure to follow policieson precaution orders or failure to conduct appropriate staff staff education/training

faulty initial assessment process

Equipment factors 

nonfunctional paging system that delays communication with the individuals physician HERKUTANTO

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Questions to Uncover Causes 

What safeguards are missing in missing in the process? 

If the process already contains safeguards (for If example,, double checks), why might they not example not work to work to prevent the failure every time? time?



What would have to o wron for a failure like this to happen? happen?



If this failure occurred, why would the problem If not be identified before it affected an individual?

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? n e p p a h l u o c

t a h W

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Contributory Factors to Suicide

? n e p p a h l u o c

t a h W

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DIABETES SCREENING

? n e p p a h d l u o c

t a h W

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Laboratory Test Ordering Proces s

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6


Disain Ulang Proses HERKUTANTO


TUJUAN & HASIL 

Teridentifikasinya PROSES BARU yang bebas dari modus kegagalan



Lembar langkah2 PROSES BARU Lembar

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

NO

YES Does an effective control measure already exist for the identified hazard? CONTROL THE HAZARD (=BARRIER)

YES

Do not proceed to find potential causes for this failure mode

NO Is this hazard so obvious and readily apparent that a control measure is not warranted? DETECTABILITY (FORESEEABILITY) HERKUTANTO

STOP

YES NO

Proceed to Potential Causes for this failure mode

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PREPARING TO REDESIGN 

Conduct a literature search to gather relevant information from the professional era ure.

o no re nven

e w ee



Network with colleagues



Recommit to out of the box thinking HERKUTANTO

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REDESIGN STRATEGIES 

Prevent the failure from happening (decrease likelihood of occurrence) occurrence )



Prevent the failure from reaching the



Protect individuals if a failure occurs (decrease the severty of the efects)

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PROSES RISIKO TINGGI     

 

METODE REDESIGN

V ar iable input Complex Nonstandarized Tig htly C oupled epen en on uman intervention Time constr aints Hier ar chical culture

   

   

HERKUTANTO

Dec r eas ing var iability S implify S tandar dizing Loosen coupling of proces s Optimise Optimis eR Redundancy edundancy B uilt in fail safe mechanis m Documentation E s tablis hing a culture of teamwork

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REDESIGN PROCESS Process

Failure Mode

Potential Effect

Potential Causes

Redesign Recommend ations

PIC

Target Completi on date for test

New Process Implementat ion date & Actions

Outcome Measure / Monitoring mechanism

1

2

3

4

5

6

7

8

9

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Proses Redesign

Bandingkan :

Analisis & Ranking

Analisis & Ranking

Failure Mode

Effect

Causes

Failure Mode

Effect

Causes

Proses Baru

Proses Lama HERKUTANTO

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7


Analisis dan Uji Coba Proses Baru HERKUTANTO


TUJUAN & HASIL 

Terujinya PROSES BARU dilapangan



Le

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SIKLUS PDSA

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SIKLUS PDSA

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A J R A E B K O A I B J U M E L HERKUTANTO

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A J R A E B K O A I B J U M E L HERKUTANTO

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8


Implementasi & Monitor Proses Baru HERKUTANTO

6 Disain ulang Proses 7 Analisis dan Uji Coba Proses Baru 8 Implementasi dan Monitor 91 Proses Baru

TUJUAN & HASIL 

PENERAPAN PROSES BARU 



Manajemen Perubahan

Lembar MONITORING PROSES BARU Lembar

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Strategies for Creating and Managing the Change Process 

Establish a sense of urgency



Create a guiding coalition



Develop a vision and strategy



Communicate the changed vision



Empower broadEmpower broad-based action



Generate shortshort-term wins



Consolidate gains and produce more change



Anchor new approaches HERKUTANTO Anchor in the culture

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LEMBAR MONITOR PROSES BARU

HERKUTANTO HERKUTANTO

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LEMBAR MONITOR PROSES BARU

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KESIMPULAN 

PROSES BARU YANG LEBIH AMAN





RUMAH SAKIT YANG AMAN

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13. FMEA 2016-Penyuluhan Singkat.pdf

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