Global Excellence

Risk Management
Trough P-FMEA

Presented by : Jesaya Jaduman S.

Global Excellence
Capability Building....
Dipl. Eng, ST
 Global Excellence

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Berbagi, Berkarya, Berkinerja

Capability Building....
 Objectives

➢ Participants understand the FMEA Concept, Definition, Objectives, Types of FMEA

➢ Participants can use and implement the method FMEA (Identify potential failures, analyze causes,
prioritizing corrective actions and document it
➢ Recognize the purpose, objectives of the AIAG and VDA FMEA and the 7 Step Approach, including:
• - System analysis – Planning and preparation, structure analysis, and function analysis
• - Failure analysis and risk mitigation – Failure analysis, risk analysis, and optimization
• - Risk communication – Results documentation

➢ Assign SEVERITY OCCURRENCE & DETECTION rankings using the new tables based on data provided from
the Case Study

➢ Prioritize actions using the action priority tables (AP)

➢ Develop the COQ from the process FMEA activity taking account of company level data affected by the
PFMEA

➢ Apply the steps involved to achieve a successful process FMEA using the new 7 step approach

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Introductions Jesaya Jaduman SAMOSIR

Professional Qualifications :
▪ Six Sigma Black Belt & Lean Six Sigma Black Belt (Operation Excellence Expert)
▪ CQI-IRCA Lead Auditor for QMS ISO 9001, AQMS IATF 16949, OHSMS ISO 45001/OHSAS
18001, EMS 14001, FSMS ISO 22000, AMS ISO 55001, ISMS ISO 27001 & ABMS ISO 37001
▪ Learning & People Development,
▪ Safety Expert, Others

Academic Qualifications :
▪ Bachelor Degree in Electrical Engineering from Institute Technologi Budi Utomo, graduated in
2018
▪ Diploma Degree in Electrical Engineering from Universitas Sumatera Utara (Government &
Group of Swiss’ Polytechnic), graduated in 1992

Professional Experience :
▪ Managerial, Management System Trainer, Lead Auditor Tutor, Auditor and Consultant

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Benefits to you!
• To maintain credibility, organizations need competent manpower /anabler, recognized and valued
worldwide.

• Organizations recognize the value of using management systems to control business risk and add
value to their business. They rely on skilled professionals to assess the performance of their
management practices to enhance efficiency and credibility.

• With increasing globalization and competitiveness, it is more important than ever for organizations to
use competent, certified practitioner & auditors.

• This meeting will give you the confidence to effectively audit a quality management system in
accordance with internationally recognized best practice techniques.

This meeting will help you:

• Understand the Key Concept of Integrate Risk Management

• Understand the Special Key Concept one of Core Tool IATF 16949 The New FMEA AIAG VDA
• Understand how to implement the 7 step approach
• Understand how to use the severity, occurrence and detection tables
• Understand how to use the action priority tables (AP)
• Understand the linkages between the cost of quality and FMEA and the financial impact FMEA has on
performance
• Become a productive team member in the development of the AIAG VDA process FMEA

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 RISK ANALYSIS /
1 MANAGEMENT

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ISO 9001:2008 (Lama) VS ISO 9001:2015 (HLS)

1. Bersifat Konvensional 1. High Level Structure

2. Prosedural Base (Theoiritis & 2. Process Based (Result Oriented

Formalitas → Write what you do, FOR Business Process→ Clause
Do what you write) 8.3.4, 6.1 & 6.3)

3. Deklarasi Pendekatan Process 3. Deklarasi Pendekatan Process

(Implisit/Conform→ Should) (Explisit/Perform/Mandatory→
Shall)

4. Belum ada jaminan dimana 4. Sudah ada jaminan dimana

proses Mencapai Target proses Mencapai Target

5. Belum ada Concept/Tools / 5. Sudah ada Concept/Tools/

methodolgy untuk mencapai methodology untuk mencapai
Target Target yaitu : PBR (Pemikiran
Berbasis Resiko) yang kita sebut
RBT (Risk Base Thinking)
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 RISK-BASED THINKING
▪ An organization needs to plan and
implement actions to address risks
and opportunities – a basis for
increasing effectiveness of the QMS,
achieving improved results and
preventing negative effects.

• Risk – effect of uncertainty; it is often expressed in terms of a

combination of the consequences of an event and the associated
likelihood of occurrence
• An effect can be positive or negative
• A positive deviation arising from a risk can provide an opportunity, but not
all positive effects of risk results in opportunity
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WHAT IS RISK ?
Risk is
Effect of uncertainty on objectives
( ISO 31000:2018 - Term and definition 3.1.)

Note 1 to entry: An effect is a deviation from the expected. It can be positive, negative or both, and
can address, create or result in opportunities and threats.
Note 2 to entry: Objectives can have different aspects and categories, and can be applied at
different levels.
Note 3 to entry: Risk is usually expressed in terms of risk sources (3.4), potential events (3.5),
their consequences (3.6) and their likelihood (3.7).

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 CONCEPT OF RISK

+
Source Event Consequence Objectives
-
Uncertainties

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 RISKS ARE ALL OVER
DIFFICULT TO BE IN CONTROL
Requirements Investment
insurance Governance codes capital Health and safety
Qualiy of
processes Standstill of
Customer requirements production
Environmental
Legal developments
issues
Internal
External control costst
Integrity
Organisation Failing projects
Natural disasters
Terrorism Information security

Sector developments, Human resources

fusions, take-overs
Insurance premiums IT-projects
Stricter Capital needs
requirements Contractual outsourcing/offshoring
financial requirements Performance improvement
organizations

External Internal
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1
ISO 31000: risicomanagment KAM manager / dag 1 /
 GENERIC RISK MANAGEMENT
(MODEL) NEEDED

Supply Food Safety of information OH&S environment

Finance quality
chain security safety machinery security

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2
ISO 31000: risicomanagment KAM manager / dag 1 /
USEFUL GUIDANCE ON RISK
Risk analysis and management are key facets of any safety
management system. Some useful standards are:
▪ ISO 31000 Risk management – Principles and guidelines
▪ ISO 31010 Risk management – Risk assessment techniques
For interested delegates, the following ISO 31000 Risks Management courses are available:

• Understanding Risk Management - ISO 31000,

• Implementing Risk Management - ISO 31000,

There are other standards that may be of use, depending on level of interest or need:
• ISO/IEC Guide 73 – Risk management vocabulary – Guidelines for use in standards
• BS 31100:2011 Risk management – Code of practice and guidance for the implementation of BS ISO 31000
• ISO 31010, Provides details on risk assessment concepts, process, and selection/comparison of risk assessment tools/techniques

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 A COHERENT SET OF THREE STANDARDS
▪ ISO Guide 73 “Risk management – Vocabulary”
▪ ISO 31000 “Risk management – Principles and guidelines”
▪ ISO/IEC 31010 “Risk management – Risk assessment techniques”

AIRMIC : Association of Insurance and Risk Manager (AIRMIC) UK

IRM : Instiute of Risk Management
The Committee of Sponsoring Organizations of the Treadway
Commission (COSO) published an Enterprise Risk Management (ERM)

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 RISK
Effect of uncertainty
on objective

Risk

Effect Uncertainty Objectives

Incomplete/ Impact
Human Customer
Positive Negative Inaccurate Competition varying levels
behavior information expectation and functions

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 EFFECTS OF UNCERTAINTY

Two sides of the same coin

We must identify
threats to achieving
our objectives

We also need to identify

opportunities that
may be missed

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RISK MANAGEMENT Coordinated activities to direct and control
an organization with regards to risk

Risk management (RM)

A structured approach to managing uncertainty:
‘Coordinated activities to direct and control an
organization with regards to risk’.

Options can include:

• Avoid the risk
• Reduce the risk
• Transfer the risk to another party
• Accept the risk

The terms ‘product’ and ‘service’ includes all output

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categories (hardware, services, software and processed
materials).
 IATF 16949/ISO 9001/27001/37001/45001/22000 VS ISO 31000

(FMEA/FMECA/ Risk Register/Aspec Impact/ HIRADC/HACCP) (Manjemen Resiko /Manrisk)

R 1A Delete/ 1.Identification / determine internal & external issue

2A
Reduce → output : List Of R/O (Contex Organization)
(-) 3 Continual 2. Analysis R/O
Improvement
/CCSR S 1 2 3 4 5
/Hirarcy /L E D C
(+) Action
Create/ 1 1 2 3 4 5
B
Raising 2B 2 2 4 6 8 10
O 1B A
3 3 6 9 12 15
Hirarcy Action 4 4 8 1 16 20
More
Effective Eliminate 2
Subtitutes 5 5 1 1 20 25
→ output : S/NS0 5
Engineering 3. Action Taken / Mitigation / Treatment
Control → output : PS DM → RCA & AT
PPE → “We Are The TOPS” (Team Oriented Problem Solving)
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Effort
 1 2

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 AIAG FMEA 4 th Edition
2

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 Jenis FMEA
1. System FMEA, Fokus meminimalkan efek kegagalan pada sistem
❖ Kegagalan : Battery gagal memberikan power yang cukup
❖ Effect : Sistem gagal untuk beroperasi
2. Design FMEA, Fokus meminimalkan efek kegagalan dari design
❖ Kegagalan : pengunci kap mobil tidak berfungsi dengan baik pada kondisi beban kejutan
❖ Effect : Pandangan pengemudi terhalang
3. Process FMEA, Fokus meminimalkan efek kegagalan pada proses
❖ Kegagalan : Operator memasang komponen terbalik
❖ Effect : Part tidak berfungsi
4. Service FMEA, Fokus meminimalkan kegagalan pada servis
❖ Kegagalan : Gagal dalam memperbaiki gejala kerusakan mesin
❖ Efek : Customer tidak puas

Jenis FMEA
❖ System FMEA dibuat pada tahap awal / konsep design, untuk mengetahui potensi
kegagalan dari sustu sistem. Hasil dari System FMEA dapat dijadikan input untuk design
FMEA yang selanjutnya diteruskan ke Proses FMEA

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❖ Design FMEA (DFMEA) dibuat pada saat pembuatan design produk, yang ditindaklanjuti
dengan perubahan sesuai informasi yang diperoleh selama product development. DFMEA
HARUS sudah selesai sebelum production drawing dikeluarkan/ direlease.
 Jenis FMEA
❖ Process FMEA (PFMEA) dibuat pada saat awal merancang sistem produksi (sebelum proses
control plan dan instruksi kerja dibuat). Informasi yang diperoleh harus ditindaklanjuti dan
HARUS sudah selesai sebelum proses produksi dimulai (termasuk proses pembuatan tooling
dan equipment)
❖ Service FMEA dibuat sebelum pelaksanaan servise dilakukan. Tujuan dari servis FMEA adalah
mendeteksi kegagalan pada saat aktivitas servise dilakukan. Untuk mengidentifikasi kebutuhan
akan skill dari operator, kebutuhan alat penunjang untuk aktivitas servis dll.

Jenis FMEA
System Design Process Service

Components Components Manpower

Machine Manpower/
Subsystems Subsystems Human resources
Main Systems Main Systems Method
Material Machine
Measurement Method
Environment Material
Measurement
Environment
Machine
Human Resources
Tools
Work Stations Task
Production Lines Work Station
Process Gauges Service Line
Operator Training Service Performa
Operator Training

Focus : Minimize failure Focus : Minimize process

Focus : Minimize failure Focus : Minimize service
effects on the system failure on the total process
effects on the design failure on the total organization
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Objective/goal : Maximize
system quality, reliability,
Objective/goal : Maximize
design quality, reliability,
(system)
Objective/goal : Maximize
Objective/goal : Maximize the
customer satisfaction through
cost and maintainability the total (system) quality,
cost and maintainability quality, reliability and service
reliability, cost, maintainability,
and productivity
 Design FMEA – Tahapan
1. Memperoleh informasi mengenai produk
- Apa yang diharapkan dari design, misalnya mempunyai kemampuan
menahan beban kejut, tidak mudah patah, dll.
- Keinginan dan harapan customer, misalnya : mempunyai umur pakai minimal
5 tahun
- Peraturan pemerintah yang berhubungan dengan produk
- Persyaratan produk yang telah diketahui (berdasarkan pengalaman),
misalnya produk tidak mudah berkarat pada daerah yang humadity dan
kadar garamnya tinggi.
- Persyaratan manufacturing, assembly, servise, recycle, misalnya :
produk mudah dibuat, diassembly, mudah dibongkar pasang (untuk
keperluan servise)

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 2. Membuat block diagram
Smartcard PCB

Klicked
Klicked
Klicked
Keypad Front Cover Display PCB

Klicked

Screwed
Klicked
Back Cover Frame Batterie

Other System

Design FMEA – Tahapan

3. Menentukan item/produk dan fungsi yang dituntut dari item produk tersebut.
Contoh :
Item Produk Fungsi dari item produk
Front Cover HP ❖ Melindungi bagian dalam HP dari kerusakan akibat benturan
❖ Tempat pemasangan hardware termasuk display dan keypad
❖ Memberikan aspek penampilan,hasil cat dan
assesoris lain
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 Design FMEA – Tahapan

4. Menentukan potensi kegagalan (Potential Failure)

Pontensi kegagalan merupakan KEGAGALAN produk memenuhi fungsinya.
Contoh : POTENTIAL FAILURE : Front Cover mudah retak

5. Menentukan efek dari potensi kegagalan

Contoh : Efek dari retak pada bagian lubang keypad adalah menurunkan umur
pakai Front
Cover yang mengakibatkan :
- Ketidak puasan customer pada penampilan produk
- Tidak berfungsinya bagian dalam produk akibat gangguan luar

6. Menentukan tingkat keseriusan dari efek (lihat table severity untuk DFMEA)

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 DFMEA SEVERITY
DFMEA SEVERITY (TINGKAT KESERIUSAN)

Efek Kriteria I : Severity dari kegagalan Nilai

Berbahaya tanpa Tingkat kegagalan sangat tinggi ketika potensi kegagalan berakibat terhadap kemanan 10
peringatan pengoperasian kendaraan dan / atau melanggar peraturan pemerintah tanpa ada
peringatan sebelumnya
Berbahaya dengan Tingkat kegagalan sangat tinggi ketika potensi kegagalan berakibat terhadap kemanan 9
peringatan pengoperasian kendaraan dan / atau melanggar peraturan pemerintah dengan adanya
ada peringatan sebelumnya
Sangat Tinggi Kendaraan /item tidak beroperasi (kehilangan fungsi utamanya) 8
Tinggi Kendaraan /item beroperasi tetapi dengan peformanya berkurang. Pelanggan sangat 7
tidak puas
Sedang Kendaraan /item beroperasi, tetapi tingkat kenyamanan tidak terpenuhi. Pelanggan tidak 6
puas
Rendah Kendaraan /item beroperasi, tetapi tingkat kenyamanan performanya berkurang. 5
Sebagian elanggan tidak puas
Sangat Rendah Item Fit & Finish/sequeak & rattle (derau) tidak terpenuhi. Kerusakan dirasakan oleh 4
kebanyakan pelanggan (lebih besar dari 75%)
Minor Item Fit & Finish/sequeak & rattle (derau) tidak terpenuhi. Kerusakan dirasakan oleh 50% 3
pelanggan
Sangat Minor Item Fit & Finish/sequeak & rattle (derau) tidak terpenuhi. Kerusakan dirasakan oleh 2
sedikit pelanggan (kurang dari 25%)
Global
Tidak ada
Excellence
Hampir tidak ada efek 1
 Design FMEA – Tahapan
7. Menentukan penyebab kegagalan
Penentuan penyebab kegagalan harus difokuskan pada kegagalan dari design,
Misalnya :
- Ketebalab yang telah ditentukan masih kurang
- Campuran material kurang sesuai

8. Menentukan tingkat kejadian atau seberapa sering penyebab kegagalan

tersebut terjadi (lihat tabel occurance DFMEA)

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 DFMEA OCCURANCE
DFMEA OCCURANCE (TINGKAT KEJADIAN)
Probability kegagalan Kemungkinan Tingkat Kegagalan Nilai
≥ 100 per seribu kendaraan /item 10
Sangat tinggi : kegagalan yang terus menerus
50 per seribu kendaraan /item 9
20 per seribu kendaraan /item 8
Tinggi : kegagalan sering terjadi
10 per seribu kendaraan /item 7
5 per seribu kendaraan /item 6
Sedang : Kegagalan yang terjadi kadang-kadang 2 per seribu kendaraan /item 5
1 per seribu kendaraan /item 4
Rendah :Relatif sedikit kegagalan 0.5 per seribu kendaraan /item 3
Sangat rendah : kegagalan hampir bisa 0.1 per seribu kendaraan /item 2
diidentifikasikan
Hampir tidak terjadi ≤ 0.010 per seribu kendaraan /item 1

Source : FMEA Manual (QS 9000)

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 Design FMEA – Tahapan

9. Tentukan sistem kontrol aktual yang dilakukan untuk mendeteksi atau mencegah
penyebab kegagalan (current design control : Preventive dan Detection)
Misalnya :
- Test ketahanan
- Uji material
10. Tentukan nilai kemampuan sistem kontrol design dalam mendeteksi penyebab
kegagalan (kemampuan sistem kontrol / detection, lihat tabel detection DFMEA)

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 DFMEA DETECTION
DFMEA DETECTION (TINGKAT DETEKSI)
Deteksi Kriteria : Kemungkinan deteksi oleh sistem control design Nilai
Hampir pasti tidak Kontrol design tidak dapat mendeteksi penyebab/mekanisme kegagalan 10
dapat mendeteksi atau dalam kata lain tidak dapat kontrol design
Kemungkinan amat sangat kecil, kontrol design akan dapat mendeteksi 9
Amat sangat kecil
penyebab/ mekanisme gangguan
Kemungkinan sangat kecil, kontrol design akan dapat mendeteksi 8
Sangat kecil
penyebab/ mekanisme gangguan
Kemungkinan kecil sekali, kontrol design akan dapat mendeteksi 7
Kecil sekali
penyebab/ mekanisme gangguan
Kemungkinan kecil, kontrol design akan dapat mendeteksi penyebab/ 6
Kecil
mekanisme gangguan
Kemungkinan sedang, kontrol design akan dapat mendeteksi penyebab/ 5
Sedang
mekanisme gangguan
Kemungkinan besar, kontrol design akan dapat mendeteksi penyebab/ 4
Besar
mekanisme gangguan
Tinggi Kemungkinan tinggi, kontrol design akan dapat mendeteksi penyebab/ 3
mekanisme gangguan
Sangat Tinggi Kemungkinan sangat tinggi, kontrol design akan dapat mendeteksi 2
penyebab/ mekanisme gangguan

Global
Sangat Jelas Excellence
Kontrol design hampir pasti mendeteksi penyebab/mekanisme kegagalan 1
 Design FMEA – Tahapan
11. Hitung Nilai RPN
RPN = Severity x Occurance x Detection
12. Tentukan usulan untuk memperbaiki /mengurangi resiko kegagalan
- Usulan dapat lebih dari satu tergantung dari ide usulan yang masuk
- Usulan fokus pada item yang mempunyai nilai RPN paling tinggi atau nilai severity tinggi
- Jika nilai RPN kecil atau dibawah nilai standar yang ditentukan customer/perusahaan
maka tidak perlu dibuat usulan perbaikan
- Tentukan penanggung jawab dan target waktunya

Design FMEA – Tahapan

Petunjuk umum recommended action dilakukan berdasarkan :
• Prioritas berdasarkan nilai RPN yang tertinggi
• Apabila ada 2 nilai RPN yang sama, prioritas utama diberikan kepada item yang mempunyai nilai
severity yang lebih tinggi
• Perhatian lebih harus dilakukan apabila nilai keseriusan dari efek kegagalan tinggi (severity)
• Apabila nilai occurance tinggi, maka biaya produksi meningkat dikarenakan banyak terjadi defect
•Global
ApabilaExcellence
nilai detection tinggi dapat berakibat pada ketidakpuasan customer. Customer
kemungkinan menerima barang defect akibat lolos dalam pengecekan
 Design FMEA – Tahapan
Petunjuk dalam menentukan batasan nilai RPN untuk recommended Action :
• Untuk critical item, apabila 90% dari semua kegagalan harus dianalisa
- Skala rating 1-10
- Maksimum RPN = 1000 (10x10x10 dari nilai occurance, detection dan severity)
- 90% dari 1000 adalah 900
- Batasan RPN = 1000-900 = 100
• Jadi untuk 90% confidence level batasan RPN adalah 100
• Nilai diatas 100 harus dilakukan corrective action

Design FMEA – Tahapan

13. Evaluasi usulan perbaikan
- Tulis tindakan yang diambil berdasarkan usulan perbaikan yang direncanakan
- Hitung kembali nilai Severity, Occurance, Detection dan nilai RPN yang baru
setelah perbaikan
- Jika nilai RPN masih tinggi dibuat kembali usulan perbaikan, jika nilai RPN sudah
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dibawah nilai standar analisa DFMEA selesai
 POTENTIAL Failure Mode Effect Analysis
(DESIGN FMEA) FMEA Number : 1234
____System Page ____1 of 1___
__X__Subsystem
______Component 01.03/body Closures__ Design Responsibility. Body Engineering____ Prepared by Rudy-X6412-Body Engr

MODEL Years(s)/Vehicle(s)1999/Lion4dr/Wagon___ Key Date 99.03 01 ER_____ FMEA Date (Orig.)99 03.22 (Rev) 99 07 14

Core Team T. Fender-Car Product Dev..Childers-Manufacturing.J.Ford-Assy Ops (Dalton, Henley Assembly Plants)________________

Item Pote S C Potential O D Action Result

Potenti Current Responsib
ntial e l Cause(s) c e R
al Design Current ility & Action Taken S O D R
Function Failu v a Mechanism(s) of c Recommended
Effect(s) Control Design t P Target
re failure Action(s) e c e P
of S U Preventi Control e N Completit
Mod v c t N
failure S r on c ion Date
e

Front Door LH Kara Mengur 7 Bagian tepi atas 6 Test 7 29 Tambahkan test Rudy- Berdasarkan hsl tes (test no. 7 2 2 2
H8HX-0000-A t angi pelapisan wax ketahanan 4 ketahanan korosi Body Eng 1481) bgn tepi atas 8
-Tempat pad umur seperti yg telah T-118, T- 99.01.15 ditambahkan 125mm
keluar masuk a pintu yg ditentukan 031, T-109
dr mobil bagi mengak terlalu rendah
- Melindungi an ibatkan
baw : Ketebalan wax 4 Test 7 19 Tambahkan test Dikombin Hasil Test (test no.1481) 7 2 2 2
penumpang dr spt yg telah Ketahanan 6 ketahanan korosi asikan menunjukkan bhw 8
cuaca ah -Penam
pint ditentukan kendaraan Lakukan DOE utk dgn test ketebalan wax spt yg telah
kebisingan pilan yg
u kurang sama ketebalan wax diatas ditentukan sudah cukup
dan tabrakan tidak
bagi seperti di Rudy DOE menunjukkan 25%
samping memus
an atas Body Eng variasi dari ketebalan wax
- Tempat kan krn
dala 99.01.15 masih dpt diterima
bergantung/su cat yg
m berulan
pport utk Formula wax tdk 2 Physical 2 28 Tidak ada
perangkat g
sesuai dan
keras pintu - Tidak Chemical
- Termasuk berfung Lab. Test-
spion, engsel- sinya report no.
engsel, kunci interior 1265
palang dan bagian
pengatur pintu dalam Udara terjebak 5 Alat bantu 8 28 Bentuk team utk Body Eng Berdasarkan test, 3 7 1 3 2
mencegah wax investigasi 0 mengevaluasi & Assy tambahanlubang ventilasi 1
- Memberikan
masuk ke bagian design dgn menggunakan Ops diberikan pada area yg sulit
permukaan
sudut non- spray produksi 99 11 15
yang baik utk
fungtion dan wax yg telah
keperluan
spray head ditentukan
penampilan
- Cat dan soft Ruang yg kurang 4 Evaluasi 4 11 Bentuk team utk Body Eng Evaluasi menunjukkan 7 1 1 7
trim antara panel gambar 2 mengevaluasi & Assy kepala spray dapat masuk
untuk masuknya untuk menggunakan Ops dengan baik

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spray masuknya alat bantu dari 99 11 15
kepala kepala spray
spray
 FMEA Process
Subsistem S K Penye O Kontrol Yg
bab dilakukan Tanggun Hasil Tindakan
Pote e l c
Efek dari Potensi D R Usulan g Jawab
nsi v s c
potensi Kegag Penc Det e P Perbai & Target Tindakan S O D R
Kega
Tuntutan Kegagal an alan egah eks t N kan Penyeles Yang e c e P
galan
Fungsi an i aian diambil v c t N

Apa fungsi, Apa yg bisa

Seberapa dilakukan?
ketentuan
Apa serius efek
dan
efeknya? dari -Merubah design
persyaratan
kegagalan
tersebut -Merubah proses

Apa yang berpotensi -Menerapkan

menjadi masalah kontrol khusus
(potensi kegagalan)
-Tidak berfungsi -Merubah standar,
- Berfungsi tetapi tdk Apa Seberapa
optimal penyebabnya? sering terjadi prosedur atau
- Kadang-kadang
tidak berfungsi pedoman
- Fungsi tdk sesuai
yang diharapkan Bagaimana cara
mencegah dan
cara deteksinya?

Seberapa baik
metode tst dlm
mendeteksi
kegagalan?

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 Proses FMEA-Ruang Lingkup
❖ PFMEA adalah suatu analisa teknik untuk memahami potensi kegagalan pada proses produksi.
Asumsi dibuat bahwa design produk sudah baik akan tetapi proses produksi gagal memnuhi
tuntutan/persyaratn pada design.
Misalnya :
- Diameter lubang kebesaran
- Pelapisan yang kurang
- Kekerasan material kurang, dll
❖ Defenisi custommer pada PFMEA pada umumnya adalah “Pengguna akhir/end user”. Customer
dapat juga berarti proses selanjutnya atau proses assembly atau servis.

Proses FMEA – Tahapan

1. Memperoleh informasi mengenai produk dari spesifikasi produk, produk similar, DFMEA,
dll
2. Tentukan Flow Proses Produksi
Flow proses adalah urutan pengerjaan suatu produk dari awal sampai menjadi produk jadi
Contoh : Flow prose pembuatan Ayam Goreng

Global
Proses 1
Dicuci
Excellence
Proses 2
Dibumbui
Proses 3
Digoreng
Proses 4
Dihidangkan
 Proses FMEA – Tahapan
3. Tentukan Persyaratn Produk pada tiap tahapan proses
Persyaratan produk adalah karakteristik atau tuntutan yang harus dipenuhi oleh produk pada
setiap tahapan proses untuk memenuhi fungsi dari produk tersebut.
Contoh : Persyaratan produk padasetiap tahapan proses pembuatan ayam goreng
Proses Dicuci Dibumbui Digoreng Dihidangkan
Karakteristik Tidak ada kotoran Bumbu meresap Matang Dipotong-potong
Produk
Tidak gosong

Proses FMEA – Tahapan

4. Menentukan potensi kegagalan
Potensi kegagalan merupakan KEGAGALANdalam memenuhi persyaratan / tuntutan produk
POTENTIAL FAILURE >< REQUIREMENT
Contoh :

PROSES TUNTUTAN PRODUK PETENTIAL FAILURE

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Pemberian Bumbu Bumbu meresap Bumbu tidak meresap
 Proses FMEA – Tahapan
5. Menentukan efek kegagalannya
Efek kegagalan dari bumbu tidak meresap “Rasa ayam goreng tidak gurih”
6. Menilai keseriusan dari efek yang ditimbulkan (lihat tabel severity)

Proses FMEA – Tahapan

7. Tentukan penyebab potensi kegagalan

Mesin Tekanan cooker kurang

Suhu Cooker
Terlalu Rendah
Bumbu tidak meresap
Bumbu terlalu encer
Ayam sudah dimasukkan
Material Sebelum airmendidih
Method

Catatan :
• Pastikan penyebab yang ada sudah benar-benar merupakan akar permasalahan.
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• Gunakan 5W bila perlu (Why, Why, Why,…) untuk mencari akar permasalahan
3 ISO/TS 16949:2009 3rd Edition
Migration
To IATF 16949:2016 1st Edition

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 Preview of New Standards.

ISO/TS 16949:2009, the automotive quality

management system standard that’s based on ISO
9001 is changing.

The new standard will be known as IATF

16949:2016 and will be published in October 2016.
All organizations currently certified to
ISO/TS16949:2009 will need to successfully
transition by 14th September 2018.
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 Preview of New Standards.

In October 2016, IATF is expected to publish

IATF 16949:2016 This new standard will
supersede and replace the existing ISO/TS
16949, which defines the requirements of a
quality management system (QMS) for
organizations in the automotive industry.

IATF 16949:2016 will be aligned with and

refer to ISO 9001:2015. IATF 16949:2016 will
not be a stand-alone quality management
standard, but it will be implemented as a
supplement to, and in conjunction with ISO
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 Preview of New Standards.

As highlighted by IATF, the goal of this new

international standard is the development of a quality
management system that:

• Provides for continual improvement

• Emphasizes defect prevention
• Promotes reduction of variation
and waste in the supply chain

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 Preview of New Standards.

• October 2016 IATF 16949:2016 will be released and replace ISO TS

16949:2009
• IATF 16949:2016 fully respect with ISO 9001:2015 structure
• IATF 16949:2016 is not a stand alone quality management system
standards, but it is implemented as a supplement to and in
conjunction with ISO 9001:2015
• IATF will ensure continual alignment with ISO 9001 by maintaining
strong cooperation with ISO , through participation in ISO/TS 176
• IATF 16949:2016 also incorporates common automotive customer
specific requirements

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 Standards Models

• Allow IATF to control the automotive

content
• Allow IATF to track implementation related
issues
• Allow IATF to provide regular
implementation support and guidance
through sanction interpretation and FAQ
• Allow IATF the ability to release a revised
standards to address weakness and new
approach at more regular intervals

Note : IATF 16949:2016 does not include the ISO 9001 text “Boxed” as with
theGlobal
currentExcellence
of ISO/TS 16949:2009
 New FMEA AIAG-VDA
4

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AIAG and VDA FMEA Background
Potential Failure Mode
and Effects Analysis Quality Management in the
FMEA Failure Mode and Effects Analysis Automotive Industry
Fourth Edition
FMEA Handbook Quality Assurance in the
Process Landscape

The acronym “FMEA” stands for Failure Mode and Effects Analysis. This tool was originally developed by the US Military in 1949 to help identify and eliminate
potential failures inherent in new hardware development programs. As a tool to reduce risk, FMEAs became an instrumental tool of industrial safety
programs in many industries as well. Today FMEAs are a cornerstone of overall quality systems around the world and across industries.
Not much has changed with how FMEAs work since their inception until 2019 when the Automotive Industry Action Group (AIAG) and Verband der
Automobilindustrie (VDA),
Germany’s association for automotive manufacturers and suppliers issued the first edition of a joint FMEA Handbook.
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AIAG and VDA FMEA Background (2)

The handbook is a collaboration between OEMs and Tier 1 supplier members of the two organizations. It represents the culmination of a three year
project completely revising FMEA methodology. The result is one common foundation for FMEAs across the global automotive sectors represented by
AIAG and VDA.
The purpose of this Guide is to highlight the 10 most important aspects of the new AIAG-VDA
FMEA process so that practitioners can begin to formulate a plan to transition their organization to the new methodology.

AIAG and VDA project objective Effective FMEA and the assessment of risks are becoming more critical in
today’s environment, such as:
The AIAG and VDA project objective was to provide consistent
direction and guidance to all automotive suppliers. The rapid growth in both component and systems interactions
Legal obligations of producers
The update includes: Specialized technologies
Best practices
Improved examples An effective FMEA also requires:
Alignment to functional safety A cross functional team approach
Clear system boundaries
The project team also engaged with SAE J1739 Committee. Concise documentation of risks and actions
There’s an upcoming revision on this and the project team made
efforts to align with the upcoming revision of SAE J1739 due for
release. The 1st edition has been released in English via the AIAG and in German
Global Excellence via VDA. The handbook is available as a hard copy and as an eDocument.
Highlight the 10 most important aspects of the new
AIAG-VDA FMEA process so that practitioners can
begin to formulate a plan to transition their organization
to the new methodology.
The changes to FMEAs are substantial. They will likely require more time to perform, there will be a learning curve for team's comfortable with
the old process and the FMEA documentation is more layered and complex.
However, the added effort will yield substantially better results due to a more comprehensive analysis of the process, a deeper understanding
of the inherent failure chains and a laser-focus on risk mitigation and design or process optimization.
We like that there will be a common methodology worldwide and that it brings together the best FMEA practices that have been used around the
globe for decades. We also like the tone of the new Handbook that makes it clear that FMEAs are comprehensive, analytical and fact-based.
But, change is hard and those of us who are very comfortable with current FMEA methodology may feel like we are learning a new language as
we cut our teeth with the new process.
Here are the 10 essential things you need to know about AIAG-VDA FMEAs.

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1 | Prevention vs Detection
Good Changes Improve the Strength of FMEAs

The new AIAG-VDA FMEA process places greater emphasis on PREVENTION vs DETECTION.

For a Design-FMEA, Detection Controls are the basis of the robustness of the design.
Prevention Controls describe how a potential cause that may result in a Failure Mode will be mitigated while Detection Controls are
intended to detect (not mitigate) the potential existence of a Failure Cause or Failure Mode.
For a Process-FMEA, emphasis is placed on Prevention Controls (that eliminate the Failure Cause or reduce its rate of
occurrence) as well as Detection Controls (that detect a Failure Cause or Failure Mode)

2 | FMEAs and COQ

The FMEAs and Cost of Quality go hand-in-hand. While the immediate benefit of the FMEA is mitigation of risk, it should translate into a reduction in the
Cost of Quality (COQ). COQ is made up of four cost components: Prevention Costs, Appraisal Costs, Internal Failure Costs and External Failure Costs.
Effective FMEAs lead to the reduction of Internal and External Failure Costs (which combined are known as the Costs of Poor Quality). Of course, there are
costs associated with conducting an FMEA and those fall into the Prevention and Appraisal Costs categories.
An efficient FMEA will see Failure costs will go down substantially more than the corresponding increase in Prevention and Appraisal Costs.
While measuring Cost of Quality pre- and post-FMEA isn't specified in the AIAG-VDA FMEA Handbook, it should be a key tool for management to evaluate
FMEAGlobal Excellence
effectiveness and efficiency.
3 | FMEA Project Planning
Planning and preparation for the FMEA is critical to a successful FMEA and is the first step in conducting an FMEA.
Project planning can be done by considering the Five T’s: inTent, Timing, Team, Tasks and Tools.
Together these answer questions that will impact the rest of the FMEA including:
inTent: What is and isn't included in the scope of this project and why is the FMEA being undertaken?
Timing: When will the FMEA be done? (includes when in the product/process development cycle to conduct the study with deadlines for completing the
FMEA).
Team: Who will be on the core team and extended team and what are the members' roles and responsibilities?
Tasks: What work needs to be done by the team?
Tools: What tools will the team use or will the team need to complete the project?

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4 | Seven-Step Process

Step 1 | Planning and Preparation covers the scope definition, Step 4 | Failure Analysis marks the beginning of the next phase
project team make-up and project planning aspects of the of the FMEA, Failure Analysis and Risk Mitigation. The purpose of
study. A clear definition of the scope, set by the management the Failure Analysis Step is to identify failure modes, failure
team, minimizes the probability of “scope creep." Project effects and failures causes to establish the basis for risk
Planning is done following “Five T’s” and should be covered in assessment.
the FMEA kickoff meeting. The information from this step is the
Step 5 | Risk Analysis is where the level of risk for each failure
basis for Step 2.
mode is evaluated in terms of Severity, Occurrence and
Step 2 | Structure Analysis is used to identify and breakdown Detection (S-O-D). Items are then assigned an Action Priority
the system (design or process) into the system, subsystems Level of High, Medium or Low.
and component elements so that a comprehensive risk
Step 6 | Risk Optimization is the step where plans are developed
assessment can be conducted. This information is the basis for
that reduce risk and increase customer satisfaction by
the next step.
improving the design or process.
Step 3 | Function Analysis analyzes each System Element
identified in Step 2 in terms of its intended function(s) and
corresponding requirements. The Function Analysis leads to a Step 7 | Results Documentation is the final step where the
Global
comprehensive and Excellence
relevant Failure Analysis in Step 4. results of the FMEA study are fully documented in a report.
5 | S-O-D Rating Tables
Design-FMEAs and Process-FMEAs use the (familiar) S-O-D approach to evaluate risk.
Severity (S) is an estimate of how serious the impact of the failure effect would be assuming that a specific failure mode occurred. To determine the
Severity, consider the impact the effect would have on a customer, a customer's operation, your operation, your customer’s operation, and end-user
or the people working with the product or process.
Changes to Severity Ratings
The Severity Evaluation Criteria for Level 10 ALWAYS applies to “Safety” and the Severity Evaluation Criteria for Level 9 is ALWAYS used for
“noncompliance with regulations.”
Occurrence (O) reflects the prediction of each Failure Cause Occurring based on the type of control (behavioral, technical or best practice
methodology). For Prevention Controls with multiple Occurrence Ratings, use the rating that best reflects the robustness of the control.
Detection (D) is used to depict the relative effectiveness of the system to either prevent a potential failure mode or failure cause or to detect a failure
mode or cause has occurred.
An S-O-D evaluation (for Design and Process-FMEAs) is required for each Failure Chain (where a Failure Chain is the Failure
Mode and the corresponding Cause and Effect relationship).

6 | Failure Chains The concept of a “Failure Chain” helps to visualize failures as part of three links of a chain
comprised of the Failure Effect (FE), Failure Mode (FM) and Failure Cause (FC). In turn, this clarity
will help assign meaningful SO-D Ratings.
The Focus Element is the middle link; the Failure Mode (FM) is associated with the Focus Element.
The Next Lower Level is the third link; it represents the Failure Cause (FC) and answers the
question: “Why is the Failure Mode happening?”
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The Next Higher Level Element represents the first link; it signifies the Failure Effect (FE) and
answers the question: “What happens in the event of a Failure Mode?”
7 | Action Priority Tables
The Action Priority Table replaces the RPN (Risk Priority Number). The RPN was a cornerstone of
FMEAs since their inception.
Shortcomings with the RPN have concerned experts for years. Specifically, the RPN, which was
Severity x Occurrence x Detection gives equal weight to the S, O and D resulting in similar RPNs for
very different combinations of S-O-D.
Instead, the Action Priority Table is a risk matrix that can represent combinations of S-O, S-D and O-
D, each resulting in either a High,
Medium or Low Action Priority.
Actions to reduce risk are best addressed by focusing on reducing the Occurrence or Detection
Ratings since Severity is difficult to change. Failure Modes with a High rating MUST be addressed by
the team improving Prevention and/or Detection Controls or they must justify and document why the
current controls are adequate. Medium ratings SHOULD be addressed by the team and Low ratings
CAN be addressed by the team.

8 | FMEA-MSRs
FMEAs for Monitoring and System Response, or FMEA-MSRs, consider how systems can fail while being used by the customer. An FMEAMSR is intended
to help maintain a safe state or state of regulatory compliance during customer operation.
FMEA-MSRs have been introduced to ensure functional safety goals (as required by ISO 26262) have been fully considered and are met. They analyze
potential failures that may occur under normal operating conditions and the corresponding effect on the system. A significant focus of the analysis is
to determine if the system or the end user will detect a failure if one does occur.
Global
An FMEA-MSR Excellence
is most often used as a supplement to a DFMEA. The study uses the same seven-step process used for DFMEAs and PFMEAs.
9 | When to Use FMEAs
The new AIAG-VDA Handbook specifies three cases for when an FMEA should be conducted.
Case 1: New designs, new technology or new processes.
In these cases, the scope of the FMEA is the complete design, technology or process.
Case 2: New application of an existing design or process.
The FMEA Scope should specifically focus on the impact the new environment, location or application usage has on the existing design or process.
Case 3: Engineering changes to an existing design or process.
New technical developments or requirements, product recalls and reports of failure that lead to design or process changes should also trigger the review
and possibly revision of the existing FMEA.

10 | Transition Strategy
"Existing FMEAs developed using the previous AIAG 4th Edition FMEA [Handbook], may remain
in their original form for subsequent revisions."
This statement in the new AIAG-VDA FMEA Handbook will come as a relief to many. However,
the Handbook does specify that new projects should follow the new FMEA methodology unless
company leadership and Customer Specific Requirements mandate a different approach.
Existing FMEAs that are used as a starting point for new programs, should be updated to the
new methodology unless the new program is considered just a minor change to the existing
product or process.

Global Excellence Training on the new FMEA process will be a substantial undertaking and should start well
before it is time to conduct the first FMEA using the new AIAG-VDA Handbook.
 New FMEA AIAG-VDA
5 Implementation

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RELATIONSHIP OF CORE TOOLS

Feasibility Review

Contract Review

APQP APQP APQP APQP PPAP

Phase 1 Phase 2 Phase 3 Phase 4
Product Process
Planning
Development Development
Validation APQP
Phase 5
Mass
FMEA MSA SPC Production

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Embedding of the method in development process
➢ FMEA has to be worked out according the project plan and
evaluated to the project mile stones according to the status of the
analysis
➢ FMEA should be an integrated in design discussions and releases

➢ The process responsibility of the management is stressed

➢ Priority of FMEA, availability of resources and input dimensions
=> In practice often the biggest challenge
➢ Result communication and inspection
➢ Reviews with the management

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The slide above shows the changes between the 4th Edition AIAG FMEA and the new AIAG and VDA FMEA. This new version also replaces the VDA, product
and process FMEA Volume 4.
At first glance it may seem a little bit daunting, but your tutor will take you through the changes.
The comparisons above and overleaf show the AIAG PFMEA and steps associated with the new method. In steps 2 – 4 the box on the left is grey, the middle
is blue, and the right-hand box is purple. This is because there’s a relationship between the boxes, this will become clearer later. Also, the risk analysis
boxes are green. The severity of (FE) is also green, therefore, there appears to be logic to the colours.
Although not shown above, step 1 sets out the scope and boundaries. We will cover this later. Below is a summary of how the steps 2 – 5 above relate to
the AIAG 4th Edition:
Step 2 – Relates to item
Step 3 – Relates to function
Step 4 – Relates to failure mode and effects
Step 5 – Relates to the current controls

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Overleaf is step 6 Optimization.
 COMPARISON OF 4TH EDITION AIAG AND THE AIAG AND
VDA FMEA
STRUCTURE ANALYSIS (Step 2) FAILURE ANALYSIS (Step 4)
1. Process item
2. Process step 2. Failure 3. Failure

Severity (S)
3. Process
1. Failure mode cause

of FE
System, work element
Station number effects (FM) of the (FC) of the
subsystem, part
and name of (FE) process work
element or 4M type
focus element step element
process name

Classificatio

Occurrence
Process step/ Current Current

Detection
Potential Potential Severity Potential
function

RPN
process process
Failure effect(s) of cause(s) of
n controls controls
Mode failure failure
Requirements Prevention Detection

FUNCTION ANALYSIS (Step 3)

2. Function of RISK ANALYSIS (Step 5)
1. Function of the the process step
3. Function of

Occurrence (O)

characteristics
process item and product Current

Detection (D)
of FC / FM
the process Current

Filter code
PFMEA AP

(optional)
characteristic detection

Special
of FC
work element prevention
Function of system, control
Globalpart
subsystem, Excellence
(quantitative
and process control (PC)
(DC) of FC
characteristic of FC
element or process value is or FM
optional)
COMPARISON OF 4TH EDITION AIAG AND THE AIAG AND VDA
FMEA

Action results
Responsibilit

Occurrence
Actions

Detection
Recommende y and target

Severity

RPN
d action completion taken and
date effective
date

OPTIMISATION (Step 6)

Completion date
completion date

Occurrence (O)
with pointer to
person's name

Detection (D)
Action taken

SpProd Char
Responsible

Severity (S)

PFMEA AP
evidence
Target

Status
Prevention Detection
action action

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FMEA FOR PRODUCTS AND PROCESS

Product

Process

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ALIGNMENT OF FMEA AND PROJECT PLANNING

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STEP 1 PLANNING AND PREPARATION

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 FMEA HEADER
sdfhsiu
Process failure mode and effects analysis (process FMEA)
PLANNING AND PREPARATION (step 1)
5 PFMEA ID number: 9
1 Subject:
Company name:
6 Design responsibility: 10
2 PFMEA start date:
Engineering location:
7 Confidentiality level: 11
3 PFMEA revision date:
Customer name:
8
4 Cross-functional team:
Model year/platform:

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STEP 2 STRUCTURE ANALYSIS

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VISUALIZING STRUCTURE TREES - PFMEA

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VISUALIZING STRUCTURE TREES 4M elements
Product/process Process step/station
(man, machine, material,
(item) (process element)
environment)

Operation 10 setting
and washing parts Operator

Barcode label
Operation 20 dispenser
Pump assembly barcode label Barcode label roll
line assembly
Rear housing
Operation 30 ball
press fit

[Operation…]
Global Excellence
STEP 3 FUNCTION ANALYSIS
If we use the logical linking of a function and structure, we can ask the following questions:

What does it do?

How to achieve the product/process requirements – from right to left

(Process item Process step Process work element)

How?

Why implement the product/process requirements - from left to right

(Process work element Process step Process item)

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REQUIREMENTS

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Global Excellence
STEP 4 FAILURE ANALYSIS

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FAILURE CHAIN

What
happens? Failure mode Failure cause
Failure effect Why?

Focus element

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 FAILURE EFFECTS
Failure effects are related to functions of the process item (system, subsystem, part element or name of process). Failure effects should be described
in terms of what the customer might notice or experience. Failures that could impact safety or cause noncompliance to regulations should be clearly
identified in the PFMEA.
Customers may be:
Internal customer (next operation/subsequent operation/operation targets)
External customer (next tier level/OEM/dealer)
Legislative bodies
Product or product end user/operator

Failure effects are given a severity rating according to:

Your plant: The effect of the failure mode assuming the defect is detected in the plant (what action will the plant take e.g. scrap)
Ship to plant: The effect of the failure mode assuming the defect is not detected before shipping to the next plant (what action will the next plant take
e.g. sort)
End user: The effect of the process item effect (what will the end user notice, feel, hear, smell, etc. e.g. steering is stiff)
Note: FE definitions need to be defined in such a way, that there is no ambiguity when ranking severity.
You should ask the following questions to determine the potential impact of failure effects:
An important question to ask is ‘does the failure mode physically impact downstream processing or cause potential harm to equipment or operators?’.
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This may also be an inability to assemble or join to a mating component at any subsequent customer's facility
If this is the case, then identify the manufacturing impact your plant and/or ship-to plant in the PFMEA. If not, then go to question 2.
FAILURE MODE

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FAILURE CAUSE

Typical questions categorized as 4M questions:

Man Machine
• From parts available within the process, • Can automated process be interrupted?
can wrong part be applied?
• Can no part be applied? • Can inputted data be entered incorrectly?
• Can the parts be loaded incorrectly? • Can machine be run in manual mode,
bypassing automated controls?
• Can parts be damaged - From pickup to • Is there a schedule to confirm prevention
application? and detection controls?
• Can wrong material be used?
Material (indirect) Environment (milieu)
• Can too much, too little, or no material • Is lighting adequate for task?
be used?
• Can material be applied to a wrong • Can parts used within the process be
location? considered foreign material?

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 FAILURE STRUCTURE AT DIFFERENT LEVELS

Operator
Process function:
Operator – Selects the
Pump assembly line Operation 20 barcode correct barcode dispenser
Function: label assembly and rear housing
Identify pump after Process function: Failure:
assembly is completed Assemble barcode label to Incorrect barcode dispenser
rear housing in the correct selected
Effect on process: position
Incorrect pump assembly Failure:
and online performance Barcode dispenser
Incorrect barcode label
test will be selected fitted Process function:
Barcode dispenser and
barcode label dispenses label
What does it do? How?
Operator
Process function:
Operator places label onto
Global Excellence read housing
STEP 5 RISK ANALYSIS

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CURRENT PREVENTION CONTROLS

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EVALUATING SEVERITY, OCCURRENCE AND DETECTION

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SPECIAL CHARACTERISTICS

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ACTION PRIORITY (AP)

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PURPOSE OF THE OPTIMIZATION STEP

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ASSIGNMENT OF RESPONSIBILITIES

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 Summary
6

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Strategi penanganan potensi kegagalan

Tradisional
1. Menurunkan severity
2. Menurunkan tingkat kejadian
3. Memperbaiki kemampuan deteksi

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Pendekatan terbaik:
1. Menghilangkan tingkat kejadian
2. Menurunkan severity
3. Menurunkan tingkat kejadian
4. Memperbaiki kemampuan deteksi
5. Pemahaman akan fungsi deteksi pada saat customer
pakai.

Global Excellence
Criticality Analysis (“Area” Chart)

10
O 9
C 8
C HIGH
U 7 PRIORITY
R 6
R 5
E 4 MEDUIM
N 3 PRIORITY
C
E 2
1 LOW
0 PRIORITY
0 1 2 3 4 5 6 7 8 9 10
SEVERITY
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 Perbandingan Metode
Failure Mode Severity Occurrence Detection RPN
A 4 5 9 180
B 4 8 2 64
C 9 2 1 18

Criticality 10
O 9
Method C 8 B
C 7
U
6
R
R 5 A
E 4
N 3
C 2 C
E 1
0
0 1 2 3 4 5 6 7 8 9 10
Global Excellence SEVERITY
Score the FMEA
FMEA WORKSHEET PRODUCT:
TYPE: DESIGN PROCESS OTHER___________________ ITEM:

FUNCTION POTENTIAL EFFECTS OF POTENTIAL

FAILURE MODE FAILURE S CAUSES O

1 a 7 3
b 4 9

10 2 a 2 3
b 7 6
O 9 1b c 5 8
C 8 4b 2c
C 7
3 a 8 2
b 6 4
U
R 6 c
d
3
3
3
4
5 2b
R 4 a 4 2
E 4 3b b 4 8
3d
N 3
C 2 2a 3c 1a
4a 3a
E 1
0
0 1 2 3 4 5 6 7 8 9 10
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Pertimbangan dalam penentuan priorotas
tindakan (1/2)

1. Prioritas harus difokuskan kepada potensi

kegagalan dengan severty tertinggi. Jika
nilai severty 10 atau 9, maka team harus
memastikan pengontrolan resiko melalui
perbaikandesign.
2. Jika potensi kegagalan dengan severity 8 atau
dibawahnya, maka team harus memastikan
pencegahan atau pendeteksian yang
terbaik.

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Pertimbangan dalam penentuan priorotas
tindakan (2/2)

Mengurangi severty :
Hanya dapat dilakukan dengan memperbaiki
design atau proses

Mengurangi occurence :
Menghilangkan atau mengontrol penyebab potensi
kegagalan dengan melakukan perbaikan terhadap
proses.

Mengurangi detection :
Metode terbaik adalah penggunaan antisalah atau
pokayoke.
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BUKTI OBYEKTIF UNTUK FMEA
❑ Proses yang tercakup dalam aplikasi FMEA
❑ Record dari DFMEA dan PFMEA
❑ Reaction plans terhadap semua FMEA dengan
nilai RPN tinggi
❑ Hubungan antara FMEA and Control Plan

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STEP 7 RESULTS DOCUMENTATION

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COST OF QUALITY

Global Excellence
 ~ The End ~

THANK YOU FOR YOUR

PARTICIPATION

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