5.
Prioritaskan kegagalan
proses.
2.
6.
Tentukan mengapa
kegagalan dapat terjadi.
7.
8.
9.
3.
4.
Identifikasi proses yg
terganggu atau terjadi
kegagalan fungsi (failure
modes)
Identifikasi efek kegagalan
proses yg terjadi pada pasien
dan efek yg berakibat serius.
What is HFMEA ?
HFMEA Terminology
LANGKAH HFMEA
1.
2.
3.
4.
5.
6.
7.
LANGKAH 1
Tentukan Topik
Tentukan topik yang akan diproses secara jelas dengan
memilih salah satu proses yang berisiko tinggi.
LANGKAH 2
Bentuk Tim
Mengumpulkan Tim (Multidisiplin)
No. FMEA
Tgl mulai ..
Data Lengkap
Pimpinan Tim
.
Tim :
Expert
Multidisiplin
Beranggotakan orang yg terlibat dlm proses
LANGKAH 3
Gambarkan Proses
A. Kembangkan & verifikasi Proses dalam
Diagram alur / flowchart
B. Buat nomor secara berurutan tiap proses yang
diidentifikasi pada diagram alur.
C. Pemilihan Proses :
LANGKAH 3
Gambarkan Proses
LANGKAH 3
Gambarkan Proses
LANGKAH 3
Gambarkan Proses
LANGKAH 3
Gambarkan Proses
LANGKAH 4
Buat Hazard Analysis
A. Kegagalan yg memiliki skor tinggi yg didahulukan
Buatlah daftar modus kegagalan yg mungkin terjadi
pada HFMEA langkah 3.
LANGKAH 4
Buat Hazard Analysis
B. Tentukan Severity and Probability dari potensi modus kegagalan
LANGKAH 4
Buat Hazard Analysis
LANGKAH 4
Buat Hazard Analysis
LANGKAH 4
Buat Hazard Analysis
LANGKAH 4
Buat Hazard Analysis
LANGKAH 4
Buat Hazard Analysis
Decision Tree
Gunakan Decision Tree utk menentukan apakah modus perlu tindakan lanjut diProceed
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
NO
YES
STOP
YES
Proceed to
Potential
Causes for
this failure
Do not proceed
to find potential
causes for this
failure mode
HFMEATM
Hazard Score
Severity
Control Measure
Is there a barrier that
eliminates or substantially
reduces the likelihood of a
hazardous event occurring?
Hazard Score
Criticality
Will this failure mode result in
whole system failure or the
occurrence of an adverse
event?
Probability
Decision Tree
Severity Rating *
Probability Rating
Detection
Is this failure mode obvious,
would it be found?
Probability
How often does the
failure mode occur?
Detection
What controls are in
place to detect this
failure or the effect
of the failure?
How likely is it that
this control will
actually detect the
cause and failure
mode?
Eliminate Cause
PSA Test Ordered
Process Step : Report Result
Failure Mode: Result misread by tech
Potential Cause : Confusing readout on PSA
instrument
Action: Purchase new equipment
Measure: New equipment in place
Person Responsible: Supply Supervisor
HFMEA
Proactive
RCA
Specific Process
Reactive
Specific Event
What occurred?
Focusing on a processes
potential system failures
Flowcharting
Differences from RCAs
Akar
Masalah
Investigasi &
Analisis
Grading
Insiden
Laporan
Insiden
E
T
Retrospektiv
Proses lama
yg high risk
Proses
Modus Kegagalan
& Potential Cause
Efek /
Dampak
Tindakan
K
K
HS
Desain
Proses baru
Decision
Tree
Prospektiv