HFMEA___HFMECA.pdf

7/27/2019 HFMEA___HFMECA.pdf

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DrDrArjatyArjaty WW DaudDaud MARSMARS

HEALTHCARE FAILURE MODE EFFECT AND ANALYSIS /

ANALISIS MODUS KEGAGALAN DAN DAMPAK

HEALTHCARE FAILURE MODE EFFECT AND CAUSES ANALYSIS /ANALISIS MODUS KEGAGALAN DAN DAMPAK


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PENDAHULUANPENDAHULUAN

STRATEGI REDUKSI RISIKOSTRATEGI REDUKSI RISIKO

REDISIGN PROSES :REDISIGN PROSES :

-- HFMEA / AMKDHFMEA / AMKD

-- HFMECA / AMKDPHFMECA / AMKDP


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PRINSIP UTAMAPRINSIP UTAMA BangunBangun sistemsistem yangyang mudahmudah agaragar ORANG MUDAHORANG MUDAH

UNTUK BERBUAT BENARUNTUK BERBUAT BENAR

PastikanPastikan bahwabahwa perubahanperubahan yangyang dibuatdibuat dapatdapat

dinilaidinilai,, dievaluasidievaluasi risikonyarisikonya dandan berkesinambunganberkesinambunganpadapadajangkajangka panjangpanjang


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RISK REDUCTION STRATEGIES DIFFICULTYRISK REDUCTION STRATEGIES DIFFICULTY

& LONG TERM EFFECTIVENESS& LONG TERM EFFECTIVENESS

Types of actions Degree of LongTypes of actions Degree of Long termterm

difficultydifficulty effectivenesseffectiveness

EasyEasy LowLow

PunitivePunitive

Retraining / counselingRetraining / counseling

Process redesignProcess redesignPaperPaper vsvs practicepractice

Technical system enhanceTechnical system enhance

Culture changeCulture change

DifficultDifficult HighHigh


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STRATEGI MEREDUKSI RISIKOSTRATEGI MEREDUKSI RISIKO

IdentifikasiIdentifikasi risikorisiko dgndgn bertanyabertanya 33 pertanyaanpertanyaandasardasar ::

1.1.ApaApa prosesnyaprosesnya ??

2.2. DimanaDimanarisk pointsrisk points??

3.3.ApaApa ygyg dapatdapat dimitigatedimitigate padapada dampakdampakrisk pointsrisk points??

Definisi Proses

Transformasi input menjadi output yg berkaitan dgn

Kejadian, aktivitas dan mekanisme yg terstruktur


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STRATEGI DESIGN MEREDUKSI RISIKOSTRATEGI DESIGN MEREDUKSI 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

STRATEGI REDUKSIRISIKO


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CONTOH STRATEGI DESIGN REDUKSI RISIKOCONTOH STRATEGI DESIGN REDUKSI RISIKO

SALAH BAGIAN YG DIOPERASISALAH BAGIAN YG DIOPERASI

REDUKSI RISIKOSALAH

OPERASI

REDUKSI KEGAGALAN PREOP : Tandai bgn yg akan Dioperasi informed consentVerifikasi pasien/keluarga o/SpB

& SpAnReview X-ray

Recheck alat

REDUKSI KEGAGALAN DI OK : Verifikasi sebelum prep & drape Pastikan tanda masih terlihat

setelah draping Timeout / Verifikasi verbal

KomunikasiPre operatif

KomunikasiDi OK

Komunikasi

BerdsrkanHirarki

Komunikasi dgnPasien

/Kelurga

KetersediaanInformasi

AkurasiX-ray

RISKPOINTS

STRATEGIREDUKSIRISIKO


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REDISIGN PROSESREDISIGN PROSES

PROAKTIF RISK ASSESSMENTPROAKTIF RISK ASSESSMENT

FMEAHFMEA / AMKD

HFMECA / AMKDP


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Systematic method of identifying &Systematic method of identifying &

preventing process and product problemspreventing process and product problemsbefore they occur.before they occur.

Proactive risk assessment toolProactive risk assessment toolA team based, systematic, and proactiveA team based, systematic, and proactive

approach for identifying the ways aapproach for identifying the ways a

process or design can fail, why it mightprocess or design can fail, why it mightfail, and how it can be made safer.fail, and how it can be made safer.

What is FMEA?What is FMEA?


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FMEA TerminologyFMEA Terminology Process FMEAProcess FMEA-- Conduct an FMEA on aConduct an FMEA on a

process that is already in placeprocess that is already in place

Design FMEADesign FMEA Conduct an FMEA before aConduct an FMEA before a

process is put into placeprocess is put into place Implementing an electronic medical recordsImplementing an electronic medical records

or other automated systemsor other automated systems

Purchasing new equipmentPurchasing new equipment Redesigning Emergency Room, OperatingRedesigning Emergency Room, Operating

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


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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 notperforms in a way that is not

intended or desirableintended or desirable

MODE (M)MODE (M) : The way or manner in which: The way or manner in which

something such as a failure cansomething such as a failure can

happen. Failure mode is thehappen. Failure mode is the

manner in which something canmanner in which something canfail.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


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Can prevent errors &Can prevent errors &nearmissesnearmisses protectingprotecting

patients from harm.patients from harm. Can increase the effectiveness & efficiency ofCan increase the effectiveness & efficiency of

processprocess

Taking a proactive approach to patient safetyTaking a proactive approach to patient safetyalso makesalso makes goodbusinessgoodbusiness sense in a health caresense in a health careenvironment that is increasingly facing demandsenvironment that is increasingly facing demandsfrom consumers, regulators & payers to createfrom consumers, regulators & payers to create

culture focused on reducing risk & increasingculture focused on reducing risk & increasingaccountabilityaccountability

Why should my organizationWhy should my organization

conduct an FMEA ?conduct an FMEA ?


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FMEA has been around for over 30 yearsFMEA has been around for over 30 years

Recently gained widespread appealRecently gained widespread appeal

outside of safety areaoutside of safety area

New to healthcareNew to healthcare Frequently used reliability & system safetyFrequently used reliability & system safety

analysis techniquesanalysis techniques

Long industry track recordLong industry track record

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


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What is HFMEA ?What is HFMEA ?

Modified by VA NCPSModified by VA NCPS

Focus on preventing defects, enhancing safety, increaseFocus on preventing defects, enhancing safety, increasepositive outcome and increase patient satisfactionpositive outcome and increase patient satisfaction

The objective is to look for all ways for process or productThe objective is to look for all ways for process or productcan failcan fail

The famous question :The famous question :What is could happen?What is could happen?NotNotWhatWhatdoes happen ?does happen ?

Hybrid prospective analysis model combines concepts :Hybrid prospective analysis model combines concepts :FMEA (Failure Mode and Effects Analysis)FMEA (Failure Mode and Effects Analysis)HACCP (Hazard Analysis Critical Control Points)HACCP (Hazard Analysis Critical Control Points)

RCA (Root Cause Analysis)RCA (Root Cause Analysis)


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HFMEA Components and Their OriginsHFMEA Components and Their Origins

VV##VVResponsible personResponsible person

& management& management

concurrenceconcurrence

VV##VVActions & OutcomesActions & Outcomes

VVVVDecision TreeDecision Tree

VV##VVSeverity &Severity &

ProbabilityProbability

DefinitionsDefinitions

VVVVHazard ScoringHazard Scoring

MatrixMatrix

VVVVFailure mode &Failure mode &

causescauses

VVVVVVDiagrammingDiagramming

processprocess

VVVVVVTeam membershipTeam membership

RCARCAHACCPHACCPFMEAFMEAHFMEAHFMEAConceptsConcepts

HACCP : Hazard Analysis Critical Control Point


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1.1. TetapkanTetapkan TopikTopikAMKDAMKD2.2. BentukBentukTimTim

3.3. GambarkanGambarkanAlurAlur ProsesProses

4.4. BuatBuat Hazard AnalysisHazard Analysis5.5. TindakanTindakan dandan PengukuranPengukuran

OutcomeOutcome

LANGKAH-LANGKAH

ANALISIS MODUS KEGAGALAN & DAMPAK (AMKD)(HEALTHCARE FAILURE MODE EFFECT AND ANALYSIS)

(HFMEA)

By : VA NCPS


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

PilihPilih ProsesProses berisikoberisiko tinggitinggi yangyang akanakan dianalisadianalisa..

JudulJudul ProsesProses ::

____________________________________________________________________________________________________________________________________________________

__________________________________________________________________________________________________________________

__________________________________________________________________________________________________________________

LANGKAH 2 : BENTUK TIMLANGKAH 2 : BENTUK TIM

KetuaKetua : ________________________________________: ________________________________________________________________________________

AnggotaAnggota 1. _______________1. _______________ 4. ________________________________________4. ________________________________________

2. _______________ 52. _______________ 5. ________________________________________. ________________________________________

3. _______________ 63. _______________ 6. ________________________________________. ________________________________________

NotulenNotulen?? __________________________________________________________________________________

ApakahApakah semuasemua Unit yangUnit yang terkaitterkait dalamdalam ProsesProses sudahsudah terwakiliterwakili ?? YA / TIDAKYA / TIDAK

TanggalTanggal dimulaidimulai ________________________________________ TanggalTanggal selesaiselesai____________________________________________________________


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ANALISISANALISIS HAZARDHAZARD LEVEL PROBABILITASLEVEL PROBABILITAS

Jarang sekali terjadi (dapat terjadi dalamJarang sekali terjadi (dapat terjadi dalam

> 5 sampai 30 tahun)> 5 sampai 30 tahun)

Hampir Tidak PernahHampir Tidak Pernah

(Remote)(Remote)

11

Kemungkinan akan munculKemungkinan akan muncul

(dapat terjadi dalam >2 sampai 5 tahun)(dapat terjadi dalam >2 sampai 5 tahun)

JarangJarang (Uncommon)(Uncommon)22

KemungkinanKemungkinan akanakan munculmuncul

((dapatdapat terjaditerjadi bebearapabebearapa kalikali dalamdalam 11sampaisampai 22 tahuntahun))

KadangKadang--kadangkadang

(Occasional)(Occasional)

33

Hampir sering muncul dalam waktu yangHampir sering muncul dalam waktu yang

relative singkat (mungkin terjadirelative singkat (mungkin terjadi

beberapa kali dalam 1 tahun)beberapa kali dalam 1 tahun)

SeringSering (Frequent)(Frequent)44

CONTOHCONTOHDESKRIPSIDESKRIPSILEVELLEVEL


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11223344HAMPIR TIDAKHAMPIR TIDAKPERNAHPERNAH

11

22446688JARANGJARANG22

3366991212KADANGKADANG

33

448812121616SERINGSERING44

MINORMINOR

11

MODERATMODERAT

22

MAYORMAYOR

33

KATASTROPIKKATASTROPIK

44

TINGKAT BAHAYATINGKAT BAHAYA

HAZARD SCORE


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Does this hazard involve a

sufficient likelihood of

occurrence and severity to

warrant that it becontrolled?

(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 failuremode

Do not proceed

to find potential

causes for thisfailure mode

Decision TreeDecision TreeGunakanGunakan Decision TreeDecision Tree utkutk menentukanmenentukan apakahapakah modusmodus perluperlu tindakantindakan lanjutlanjut

didiProceedProceed....


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STEP 4 & 5


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LANGKAHLANGKAH --LANGKAHLANGKAH

ANALISIS MODUS KEGAGALAN, DAMPAK & PENYEBABANALISIS MODUS KEGAGALAN, DAMPAK & PENYEBAB

(AMKDP)/(AMKDP)/

HEALTHCARE FAILURE MODE EFFECT & CAUSES ANALYSYSHEALTHCARE FAILURE MODE EFFECT & CAUSES ANALYSYS

(HFMECA)(HFMECA)

1.1. PilihPilih ProsesProses yangyang berisikoberisiko tinggitinggi dandan BentukBentukTimTim2.2. GambarkanGambarkanAlurAlur ProsesProses

3.3. DiskusikanDiskusikan &&PrioritaskanPrioritaskan ModusModus KegagalanKegagalan

4.4.

BrainstormingBrainstorming

DampakDampak

ModusModus

KegagalanKegagalan

5.5. IdentifikasiIdentifikasi PenyebabPenyebab ModusModus KegagalanKegagalan

6.6. HitungHitung Total NPRTotal NPR((NilaiNilai PrioritasPrioritas RisikoRisiko))

7.7. DisainDisain ulangulang prosesproses// ReRe--disaindisain ProsesProses

8.8. AnalisaAnalisa &&ujiuji ProsesProses barubaru9.9. ImplementasiImplementasi & Monitor& Monitor ProsesProses barubaru

LANGKAH 1 :LANGKAH 1 :


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LANGKAH 1 :LANGKAH 1 :

PILIH PROSES YANG BERISIKO TINGGI & BENTUK TIMPILIH PROSES YANG BERISIKO TINGGI & BENTUK TIM

PilihPilih ProsesProses berisikoberisiko tinggitinggi yangyang akanakan dianalisadianalisa..

JudulJudul ProsesProses : ___________________________________________: ___________________________________________

BENTUK TIMBENTUK TIM

KetuaKetua ::________________________________________________________________________________________________________________________

AnggotaAnggota 1. _______________1. _______________ 4.4.

________________________________________________________________________________2. _______________ 52. _______________ 5..________________________________________________________________________________

3. _______________ 63. _______________ 6..________________________________________________________________________________

NotulenNotulen __________________________________________________________________________________

ApakahApakah semuasemua Unit yangUnit yang terkaitterkait dalamdalam ProsesProses sudahsudah terwakiliterwakili ?? YA / TIDAKYA / TIDAK

TanggalTanggal dimulaidimulai __________________________________ TanggalTanggal selesaiselesai______________________________________________


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Input yangInput yang bervariasibervariasi

KompleksKompleks

TidakTidak adaada standardstandard

SangatSangat tergantungtergantung padapada individuindividu

TingkatTingkat hirarkihirarki terlaluterlalu kakukaku

BebanBeban kerjakerja berlebihanberlebihan BanyakBanyakwaktuwaktu terbuangterbuang

KARAKTERISTIK PROSESKARAKTERISTIK PROSES

BERISIKO TINGGIBERISIKO TINGGI

F il i t h di tiF il i t h di ti


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Administering

Failure points where medication errors occurFailure points where medication errors occur

TranscribingPrescribing Dispensing

39% 12% 11% 38%JAMA 1995 Jul 5,274(1):29-34

STEP 2 DIAGRAM THE PROCESSSTEP 2 DIAGRAM THE PROCESS


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STEP 2 DIAGRAM THE PROCESSSTEP 2 DIAGRAM THE PROCESS

PROCESS STEPS :PROCESS STEPS :

Describe the process graphically, according to your policy & proDescribe the process graphically, according to your policy & procedure for the activity and number each onecedure for the activity and number each one

If the process is complex you may want to select one process stIf the process is complex you may want to select one process step or sub process to work onep or sub process to work on

1 2 31 2 3 4 54 5

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

PemesananPemesanan obatobat PenyimpananPenyimpanan PenulisanPenulisan obatobat PeracikanPeracikan obatobat Wrong drugWrong drug

Berlebihan (tdk vaksin tdk dlBerlebihan (tdk vaksin tdk dlm R/ tdk jls tdk sesuai dosism R/ tdk jls tdk sesuai dosis

SesuaiSesuai kebthnkebthn)) sesuaisesuai suhunyasuhunya

Wrong dosageWrong dosage

PenulisanPenulisan Obat R/Obat R/

tdktdkR/R/ DlmDlm formulariumformularium WrongWrong frequencefrequence

Wrong routeWrong route

administrationadministration

Selection &Procuremen

t

Storage

Prescribing,

Ordering,Trancribing

Preparing

&Dispensin

g

Administrat ion

LangkahLangkah 2 32 3


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LangkahLangkah 2,32,3

GambarkanGambarkanAlurAlur ProsesProses DiskusikanDiskusikan &&

PrioritaskanPrioritaskan ModusModus KegagalanKegagalan

Selection,Procurement & Storage

Prescribing /Ordering &

Transcribing

Preparing&

DispensingAdministration

The Medication Management Processes

Physician writen order

Medication order

Order pulled from chart

Order transcribed

by clerk

Writing illegibleOrder incomplete

Non formulary drug

Failure Mode


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RATING SYSTEMRATING SYSTEM(Modified by IMRK)(Modified by IMRK)

Certain to occurCertain to occur

High likelihoodHigh likelihood

ModerateModerate

likelihoodlikelihood

Low likelihoodLow likelihood

RemoteRemote

ProbabilitasProbabilitas

(P)(P)

DifficultDifficult

ModerateModerate

difficultdifficult

MpderateMpderate EasyEasy

EasyEasy

KontrolKontrol

(K)(K)

High likelihoodHigh likelihoodModerate effectModerate effect22

Almost certainAlmost certainnot to detectnot to detect

Catastrophic effect /Catastrophic effect /terminal injury, deathterminal injury, death

55

Low likelihoodLow likelihoodMajor injuryMajor injury44

ModerateModerate

likelihoodlikelihood

Minor injuryMinor injury33

Certain to detectCertain to detectMinor effectMinor effect11

DeteksiDeteksi

(D)(D)

DAMPAKDAMPAK

(D)(D)

RatingRating

Risk Priority Number (RPN) / Crit icaly Index (CI) = (D x P) x K xD

DETERMINING RISK & CRITICALITY FOR PRIORITY RANKINGDETERMINING RISK & CRITICALITY FOR PRIORITY RANKING


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DETERMINING RISK & CRITICALITY FOR PRIORITY RANKINGDETERMINING RISK & CRITICALITY FOR PRIORITY RANKING

4848443344E 4aE 4aFM 4FM 4

2272722727333333E 3bE 3b

2272722424332244E 4bE 4b

4545333355E 3aE 3aFM 3FM 3

3351512424223344E 2bE 2b

2727333333E 2aE 2aFM 2FM 2

111161168080554444E 1bE 1b

3636443333E 1aE 1aFM 1FM 1

RankRankCritCritRPNRPNDetDetProbProbSevSevEffectEffectFailureFailureModeMode

Most critical Failure mode

Most severe effect

?


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Sample Severity Scale(Modified by IMRK)

Extremely dangerous, failure would resultExtremely dangerous, failure would result

death of the individual served and have adeath of the individual served and have a

major effect on the processmajor effect on the process

Catastrophic effect, aCatastrophic effect, a

terminal injury or deathterminal injury or death55

Would result in a major injury for theWould result in a major injury for the

individual served and have major effect onindividual served and have major effect on

the processthe process

Major injuryMajor injury44

Would affect the individual and result in aWould affect the individual and result in amajor effect on the processmajor effect on the processMinor injuryMinor injury33

May affect the individual served & wouldMay affect the individual served & would

result in a major effect on the processresult in a major effect on the processModerate effectModerate effect22

May affect the individual served & wouldMay affect the individual served & would

result in some effect on the process orresult in some effect on the process or

Would not be noticeable to individual servedWould not be noticeable to individual served& would not affect the process& would not affect the process

Minor effect or No effectMinor effect or No effect11

DefinitionDefinitionDescriptionDescriptionRatingRating

Source : JCR : Joint Commision Resources


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1 in 201 in 20

1 in 1001 in 100

1 in 2001 in 200

1 in 50001 in 5000

1 in 10,0001 in 10,000

ProbabilityProbability

Documented, almost certain, theDocumented, almost certain, the

condition will inevitably occur duringcondition will inevitably occur during

long periods typical for the step or linklong periods typical for the step or link

Certain toCertain to

occuroccur55

Documented and frequent, theDocumented and frequent, the

condition occurs very regularly and / orcondition occurs very regularly and / or

during a reasonable amount of timeduring a reasonable amount of time

HighHigh

likelihoodlikelihood44

Documented, but infrequently, theDocumented, but infrequently, the

condition has a reasonable chance tocondition has a reasonable chance tooccuroccur

ModerateModerate


Possible, but no known data, thePossible, but no known data, the

condition occurs in isolated cases, butcondition occurs in isolated cases, but

chances are lowchances are low

LowLow

LikelihoodLikelihood22

No or little known occurrence highlyNo or little known occurrence highly

unlikely that condition will ever occurunlikely that condition will ever occurRemote toRemote to

non existentnon existent11


Sample Probability of Occurrence Scale(Modified by IMRK)

S l D t t bilit S l


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Sample Detectability Scale(Modified by IMRK)

0 out of 100 out of 10

2 out 0f 102 out 0f 10



10 out to 1010 out to 10

Probability ofProbability of

DetectionDetection

Detection not possible at any pointDetection not possible at any pointAlmost certainAlmost certain

not to detectnot to detect55

Unlikely to be detectedUnlikely to be detectedLow likelihoodLow likelihood44

Moderate likelihood of detectionModerate likelihood of detectionModerateModerate


Likely to be detectedLikely to be detectedHigh likelihoodHigh likelihood22

Almost always detected immediatelyAlmost always detected immediatelyCertain to detectCertain to detect11


CONTROLLABILITY


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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 or

Controls 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 or

Controls can be introduced to reduce risk to an acceptable level

within 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 or

Risk can be introduced 1 month / or low cost or

Easy1

DefinitionDesriptionRating

BRAINSTORMING POTENSIAL MODUS KEGAGALAN & BUATBRAINSTORMING POTENSIAL MODUS KEGAGALAN & BUAT


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PRIORITAS MODUSPRIORITAS MODUS KEGAGALANKEGAGALAN

116060xxxxxx1515xxxxWrong routeWrong route

administratioadministratio

nn

224848XXXXXX1212XXXXWrongWrong

FrequenceFrequence

333636XXXXXX99XXXXWrong doseWrong dose

443636XXXXXX66XXxxWrong drugWrong drugAdminiAdmini

stratiostratio

nn

55

554433221144332211EEHHMMLL11--

252555443322115544332211

1010998877665544332211

RankiRanki

ngng

ModuModu

ss

KegagKegag

alanalan

NPNP

RR

(5X(5X

7X7X

88

DeteksiDeteksiKontroKontro

llBandsBandsSkSk

oror

RiRi

sisi

koko

(3(3

X4X4

))

ProbabilitProbabilit

asasBahayaBahayaModusModus

KegagalanKegagalanProsesProses


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STEP 4 BRAINSTORMING EFFECTS OF FAILURE MODESSTEP 4 BRAINSTORMING EFFECTS OF FAILURE MODES

1616XXXXMM88XXXXNo injury butNo injury but

LOS > >LOS > >Wrong drugWrong drug

3636XXXXHH1212XXXXNo injury withNo injury with

no permanentno permanent

loss of functionloss of function

WrongWrong

dosagedosage

1212XXXXEE1212XXXXInjury withInjury with

permanent losspermanent loss

of functionof function

WrongWrong

frequencyfrequency

4040XXXXEE1010XXXXDeathDeathWrongWrong

routeroute

administratiadministrati

onon

554433221144332211EEHHMMLL11--252555443322115544332211

RR

PP

NN

(5(5

XX

88XX

9)9)

DetectionDetectionControlControlRiskRisk

CategoriCategori

es /es /

BandsBands

RiskRisk

ScorScor

ee

(3X4(3X4

))

ProbabilityProbabilitySeveritySeverityPotential effectPotential effectFailureFailure

ModeMode

10109988665544332211

STEP 5 IDENTIFY ROOT CAUSES OF FAILURE MODESSTEP 5 IDENTIFY ROOT CAUSES OF FAILURE MODES


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1616XXXXHH44XXXXMissMiss

identificidentific

ationation

No injury butNo injury but

LOS >LOS >Wrong drugWrong drug

3232XXXXHH88XXXXMissMiss

readread

instructinstruct

ionion

No injuryNo injury

with nowith no

permanentpermanent

loss ofloss of

functionfunction

WrongWrong

dosagedosage

2424XXXXEE11

22XXXXNoNo

recordrecord

in Chartin Chart

Injury withInjury with

permanentpermanent

loss ofloss of

function >function >

WrongWrong

frequencyfrequency

4040XXXXEE11

00XXXXNoNo

TrainingTrainingDeathDeathWrongWrong

routeroute

administratiadministrati

onon

554433221144332211EEHHMMLL11--

22

55

55443322115544332211

RPNRPN(5X8X9)(5X8X9)

DetectionDetectionControlControlRiskRiskCategorCategor

ies /ies /

BandsBands

RiRisksk

ScSc

oror

ee

(3(3

XX

4)4)

ProbabilitProbabilityy

SeveritySeverityPotentiPotentialal

causescauses

PotentialPotentialeffecteffect

FailureFailureModeMode

1010998877665544332211

Identify root causes of failure modesIdentify root causes of failure modes


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Identify root causes of failure modesIdentify root causes of failure modes

STEP 6 CALCULATE TOTAL RPNSTEP 6 CALCULATE TOTAL RPN


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STEP 6 CALCULATE TOTAL RPNSTEP 6 CALCULATE TOTAL RPN

4468681616MissMissideniden

tificatifica

tiontion

1616No injuryNo injury

but LOSbut LOS

> >> >

3636Wrong drugWrong drug44

221041043232MissMissreadread

instrinstr

uctiouctio

nn

3636No injuryNo injury

with nowith no

permanperman

ent lossent loss

ofof

functionfunction

3636Wrong dosageWrong dosage33

3384842424NoNorecoreco

rd inrd in

CharChar

tt

1212Injury withInjury with

permanperman

ent lossent loss

ofof

functionfunction

4848Wrong frequencyWrong frequency22

111401404040NoNo

TraiTrainingning

4040DeathDeath6060Wrong routeWrong route

administratioadministrationn

11

RankRankTotalTotal

RPNRPN

RPNRPN

CausesCausesPotentiPotenti

alal

CausesCauses

RPNRPN

effecteffectPotentialPotential

effecteffectRPNRPN

FailureFailure

ModeMode

FailureFailure

ModeModeNoNo

998877665544332211


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STEP 7 REDESIGN PROCESSSTEP 7 REDESIGN PROCESS

OutcomeOutcome

Measure /Measure /

MonitoringMonitoring

mechanismmechanism

NewNew

ProcessProcess

ImplementImplement

ationationdate &date &

ActionsActions

TargetTarget

CompletiCompleti

onon

datedatefor testfor test

PICPICRedesignRedesign

RecommeRecomme

ndationdatio

nsns

PotentiPotenti

alal

CausesCauses

PotentiPotenti

alal

EffectEffect

FailureFailure

ModeModeProcesProces

ss

998877665544332211

P i t R d iP i t R d i


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TAKE A DEEP BREATHTAKE A DEEP BREATH

Conduct a literature search to gatherConduct a literature search to gatherrelevant information from the professionalrelevant information from the professional

literature. Do not reinvent the wheelliterature. Do not reinvent the wheel

Network with colleaguesNetwork with colleagues

Recommit to out of the box thinkingRecommit to out of the box thinking

Preparing to RedesignPreparing to Redesign


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Ways to RedesignWays to Redesign

Decrease variabilityDecrease variability StandardizeStandardize

SimplifySimplify

Optimize redundancyOptimize redundancy Use technology to automateUse technology to automate

Build in fail safe mechanismsBuild in fail safe mechanisms

DocumentDocument Loosen coupling of process stepsLoosen coupling of process steps

Redesign the processRedesign the process

LangkahLangkah 88


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LangkahLangkah 88

AnalisisAnalisis dandan UjiUji ProsesProses barubaru

The team againThe team again completes steps 2, step 3completes steps 2, step 3

and step 4and step 4

Then the team should calculate a newThen the team should calculate a newcriticality index (CI) or RPN. Designcriticality index (CI) or RPN. Design

improvements should bring reduction inimprovements should bring reduction in

the CI / RPN. Ex: 30the CI / RPN. Ex: 30 50% reduction ?50% reduction ?

LangkahLangkah 99


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LangkahLangkah 99

ImplementasiImplementasi dandan MonitoringMonitoring ProsesProses

Strategies for Creating & Managing the Change Process :Strategies for Creating & Managing the Change Process :

1.1. Establish a sense of urgencyEstablish a sense of urgency

2.2. Create a guiding coalitionCreate a guiding coalition

3.3. Develop a vision and strategyDevelop a vision and strategy

4.4. Communicate the changed visionCommunicate the changed vision5.5. Empower broad based actionEmpower broad based action

6.6. Generate short term winsGenerate short term wins

7.7. Consolidate gains and produce more changeConsolidate gains and produce more change8.8. Anchor new approaches in the cultureAnchor new approaches in the culture

FMEA , HFMEA, HFMECAFMEA , HFMEA, HFMECA


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VVVVRedesign ProcessRedesign Process

VV

VV

Risk Priority Number :Risk Priority Number :

(P X D X D)(P X D X D)

(P X D) x K X D, Bands(P X D) x K X D, Bands

VVVV##Responsible person &Responsible person &

management concurrencemanagement concurrence

VVVV##Actions & OutcomesActions & Outcomes

VVVVAnalyze & Test New ProcessAnalyze & Test New Process

VVDecision TreeDecision Tree

(K,K,D)(K,K,D)

VVVVHazard Scoring MatrixHazard Scoring Matrix

(P X D)(P X D)

VVVVVVFailure mode, effect & causesFailure mode, effect & causes

VVVVVVDiagramming processDiagramming process

VVVVVVTeam membershipTeam membership

HFMECAHFMECAHFMEAHFMEAFMEAFMEAConceptsConcepts

P : Probability, D : Dampak, K : Kontrol D : Deteksi, KKD : Kritis, Kontrol, Deteksi

HFMEAHFMEA HFMECAHFMECAFMEAFMEA

LANGKAH2 FMEA, HFMEA, HFMECALANGKAH2 FMEA, HFMEA, HFMECA


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Redesign the processRedesign the processAnalyze & test the newAnalyze & test the new

processprocess77

Actions & Outcome MeasuresActions & Outcome Measures

Conduct a Hazard AnalysisConduct a Hazard Analysis

Graphically describe theGraphically describe the

ProcessProcess

Assemble the TeamAssemble the Team

Define the HFMEA TopicDefine the HFMEA Topic

HFMEAHFMEA

By : VA NCPSBy : VA NCPS

Implement & monitor theImplement & monitor the

redesigned processredesigned process99

Analyze & test the new processAnalyze & test the new processImplement & monitor theImplement & monitor the

redesigned processredesigned process88

Calculate total RPNCalculate total RPNRedesign the processRedesign the process66

IdentifyIdentify causescauses of failureof failure

modesmodesIdentify root causes of failureIdentify root causes of failure

modesmodes55

Brainstorm potentialBrainstorm potential effectseffects

of failure modesof failure modesPrioritize failure modesPrioritize failure modes44

Brainstorm potentialBrainstorm potential failurefailure

modesmodes & Prioritize failure& Prioritize failuremodesmodes

Brainstorm potential failureBrainstorm potential failure

modes & determine theirmodes & determine theireffectseffects

33

Diagram the processDiagram the processDiagram the processDiagram the process22

Select a high risk process &Select a high risk process &

assemble a teamassemble a teamSelect a high risk process &Select a high risk process &

assemble a teamassemble a team11

HFMECAHFMECA

By IMRKBy IMRK

FMEAFMEA

AMKD / HFMEA


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Proses lama

yg high risk

Desain

Proses baru

Proses Potential Cause

Failure

Mode HS

Efek /

Dampak

Decision

Tree

K

K

DT

K

E

Tindakan

AMKD / HFMEA

AMKDP / HFMECA


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AMKDP / HFMECA

PrioritasPrioritas

risikorisiko

RPN / NPRRPN / NPR

FailureFailure

Mode,Mode,

DampakDampak,,

PenyebabPenyebab

RedisignRedisign

ProsesProses

AnalisisAnalisis&&

UjiUjiProsesProses

BaruBaru ::

Re RPNRe RPN

/NPR/NPR

ImplementasiImplementasi

PROSES BARUPROSES BARU

Differences FMEA & RCADifferences FMEA & RCA


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FMEA / HFMEAFMEA / HFMEA

ProactiveProactive

Specific ProcessSpecific Process

Diagram process flowDiagram process flow

What could occur?What could occur?

Focusing on a processesFocusing on a processespotential system failurespotential system failures

Prevents failuresPrevents failuresbefore they occurbefore they occur

RCARCA

ReactiveReactive

Specific EventSpecific Event

Diagram chronological stepsDiagram chronological steps

What occurred?What occurred?

Focus on an eventFocus on an events systems systemfailuresfailures

Prevents failures fromPrevents failures fromreoccurringreoccurring


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HFMEA___HFMECA.pdf

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