IATF 16949 Training Presentation

IATF 16949:2016 Honda – COACHWORKS –REVISION 0
Copyright 2020 © DWI
IATF
16949:2016
VOLUME 2
AUTOMOTIVE QUALITY MANAGEMENT SYSTEM

Hi..!
Saya, DanangPRESENTATIONTITLE 2
Senang, Kembali bisa menyapa dan
berbagi Bersama anda kembali
• Saat ini saya masih bekerja di SGS Indonesia.
• Menjadi IATF Auditor sejak 2004
• Sebelumnya saya bekerja di Astra Daihatsu Motor
- dari tahun 1995 -2003
• Memiliki Six Sigma Master Black Belt tahun 2001
• Pernah bekerja di Dirgantara Indonesia (IPTN)
untuk proyek N250 : tahun 1992 – 1995.

SESSION 1 By the end of this session, you will be able to:
◦ Interpret the process approach
◦ Interpret the risk based thinking in IATF
◦ Interpret the turtle diagram
◦ Comprehend process effectiveness and efficiency
◦ Implemented as internal auditor (1st., party auditor)
◦ Implemented as supplier auditor (2nd., party auditor)

DIMANA PROCESS APPROACH DISEBUTKAN?
 ISO 9001:2015 - 0.3 Process approach
 Promotes the adoption of a process approach when developing,
implementing and improving the effectiveness of a quality
management system
 Enhance customer satisfaction by meeting customer requirements
 Specific requirements considered essential to the adoption of a
process approach are included in 4.4
 Understanding and managing interrelated processes as a system
contributes to the organization’s effectiveness and efficiency in
achieving its intended results
 Enables the organization to control the interrelationships and
interdependencies among the processes of the system
 Enhance overall performance of the organization

DIMANA PROCESS APPROACH DISEBUTKAN?
 ISO 9001:2015 – 4.4 Quality management system and its
processes
 The organization shall:
• Establish, implement, maintain and continually improve a
QMS, including the processes needed and their
interactions
• Determine the processes needed for the quality
management system and their application throughout the
organization

Apakah “Process” itu ?
A process : Is a chain of added value activities delivering a
product / service to a customer (internal/external) of the
process. Has a start and an end defined by two limits
INPUTINPUTINPUTINPUT
Customer’s Need
(Expressed in requirements at
the characteristic level)
OUTPUTOUTPUTOUTPUTOUTPUT
Customer’s Need
is Met
(The characteristics of the
output meet the requirements)
OutputInput
Step
1
_____
_____
_____
Step
2
_____
_____
_____
Step
3
_____
_____
_____
Step
“n”
_____
_____
_____
Has a chain of activities between these two limits

Apakah “Process” itu ?

Critical Element of Processes
Process owner
Suggested questions:
Who is it?
How do you know who is it?
Does the owner know they are owner?
Have they been given authority and
responsibility for the process

Process is defined
Where is it defined?
How is it defined ?
Who defined it?

Process is documented
Does it need to be documented?
Where is it documented?
How is it documented?

Linkage process established
What are the inputs?
Where do the inputs come from?
How many different inputs are there?
Who is the supplier(s) of the inputs?
What are the outputs?
Where do the output go?
How many different outputs are there?
Who is the customer of those outputs?
What other processes are linked to the outputs?

Critical Processes
Visualised by:
mapping the processes
developing flow-charts
conduct process analysis
develop audit check sheet, base on IATF 16949
standard, customer specific requirements,
relevant reference manual, procedures or other
documentation
CSR Matrix against Organization process
Level 1
Level 2
Level 3

Manajemen proses yang digunakan dalam suatu organisasi dan interaksi
antara proses tersebut dapat disebut sebagai 'pendekatan proses'

Struktur Proses dalam organisasi – sesuai dengan pendekatan process approach dapat (tidak
harus) dibagi menjadi :
Activity that receives inputs and converts them to outputs can be considered as a process
◦ COP : Customer orientated processes (main added value processes) – Proses utama –
proses yang harus dilakukan untuk bisa memberikan produk ke pelanggan
◦ MOP : Management Processes –Proses Pengendalian agar proses utama (COP) bisa
berjalan secara efektif dan efisien – for example : management review; internal audit
dll.
◦ SOP : Supporting Process – Proses pendukung untuk menjamin hasil dari proses
utama sesuai dengan persyaratan pelanggan – sebagai contoh : proses maintenance,
recruitment dan lain lain

Market
Analysis
Bid/
Tender
Order/
Request
Product/
Process
Design
P&P
Verification/
Validation
Product
Production Delivery Payment Warranty/
Service
Post Sales/
Customer
Feedback
Scheduling
Machining
Assembly
Packaging
Internal
Audit
Mgt.
Review
Continual
Improvement
Corrective
Action
Training
Interactions between such processes
COPs/COPs/COPs/COPs/
Core/Core/Core/Core/
or Mainor Mainor Mainor Main
The COP
“Product“Product“Product“Product
Production”Production”Production”Production”
broken into
SubSubSubSub----
ProcessesProcessesProcessesProcesses
ManagementManagementManagementManagement
ProcessesProcessesProcessesProcesses
Therese are only
some possible
examples. Some of
these are often
referred to as
“supporting
processes”

LOGO S2 Managing Skills Process
Original Date:
Notification date:
Added value: Ensure that all employees possess the skills, motivation and training required for the job
SUPPLIERS ACTIVITIES MANAGING CLIENTS
Management
Any department heads MANAGE HUMAN RESOURES
COMMUNICATON
MOTIVATION
TRAINING
Effectiveness
Results from personnel
education surveys
Rate of replies to survey
Immediate training
Assessments
Post training assessments
All processes
Employees
Trained personnel
New recruits
OutputsInputs
Site policy
Strategic policies
Process objectives
Requirements for skills and
resources
External proposals for
training
Personnel trained and available
Personnel motivated
Efficiency:
Training budget
OWNER: HR MANAGER
Improvement:
Monthly review
Resources
HR/Training/Department heads
PROCESS IDENTIFY CARD
METODE PEMETAAN DAN EVALUASI PROSES

SESSION 2
◦ Why implement Risk Based Thinking?
– What does ISO 9001:2015 require?
◦ What is Risk Based Thinking?
◦ What is Risk?
◦ What is a simple Risk Tool?
◦ How does it integrate into the Process
Approach?
◦ How do you make Risk Based Thinking a
Continual Process Improvement activity?
Risk based thinking

SESSION 2
Setelah menyelesaikan sesi ini anda diharapkan :
◦ Memahami konsep Risk Based Thinking
◦ Bagaimana diterapkan dalam sistem manajemen
mutu
◦ Rencana tindakan untuk resiko dan peluang dalam
risk based thinking
◦ Contingency plan sebagai rangkaian dari risk
based thingking
◦ Sasaran Mutu sebagai monitoring keberhasilan
Pengendalian resiko dan peluang
Risk based thinking

KENAPA RESIKO ITU PENTING?
APAKAH RESIKO ITU?
Why talk about risk?

Kenapa resiko perlu dibicarakan?
o Risiko adalah sesuatu yang kita semua hadapi setiap hari.
o Sebagai perusahaan, kita harus mengambil risiko dalam mengejar tujuan
komersial kita.
o Untuk meningkatkan kesadaran bahwa kita semua harus mengelola risiko
sebagai bagian dari kehidupan kerja kita sehari-hari dan juga pribadi.

Kenapa resiko perlu dibicarakan?
Manfaat AnalisaManfaat AnalisaManfaat AnalisaManfaat Analisa ResikoResikoResikoResiko ContohContohContohContoh
Tindakan direncanakan dan ditentukan
berdasarkan prioritas
Perencanaan pemeriksaan produk, perhatian
kepada safety part, rencana audit
Perhatian kepada kepuasan pelanggan Pencegahan problem dengan alat anti
salah/error proofing
Evaluasi secara konsisten untuk melihat
efektifitas tindakan
Target produktifitas, target efisiensi, target
pemborosan/beaya mutu/cost of poor quality
Memilih melakukan tindakan lebih
awal/proactive ketimbang preventive setelah
terjadi masalah (corrective/preventive action)
Membuat Analisa resiko – Menyusun FMEA
untuk kegagalan proses dan saat desain
produk, validasi produk setelah terjadi
perubahan

APAKAH KONSEP PEMIKIRAN BERBASIS RESIKO INI ?
WHAT IS RISK BASED THINKING (RBT) THAN

Jika saya ingin menyeberang
sebuah jalan apa yang saya akan lakukan?
• Saya mencari zebra cross
• Saya memastikan kondisi lalu lintas
sebelum saya melangkah.
• Saya tidak akan melangkah di depan mobil
yang melintas.
• Saya mengacung tangan ke pengemudi –
untuk memberitahu kalau saya akan
melintas.
• Apa lagi..?

Risk Based Thingking menggunakan
analogi reflek kehidupan sehari hari
terhadap resiko
Segala aspek resiko dipertimbangkan
dari awal dan untuk seluruh standar.
Menyusun rencana tindakan pencegahan
sebagai bagian dari perencanaan strategis
serta operasi dan senantiasa dipastikan
dan ditingkatkan

Reaksi apa yang
anda segera
Akan lakukan ?
Kenapa Resiko perlu dibicarakan?

“Persepsi kita tentang resiko
biasanya menentukan
pandangan kita tentang tingkat
risiko yang ditimbulkan oleh
suatu kegiatan “
Bagaiamana
Resiko
dipahami

Bagaiamana
Resiko (secara berbeda)
dipahami

Risk-based thinking is already
part of the process approach.
Sebagai contoh :
Untuk menyeberang jalan, saya bisa langsung atau
menggunakan jembatan terdekat. Proses mana yang saya
pilih akan ditentukan dengan mempertimbangkan risiko.

Opportunity is not always
directly related to risk but it
is always related to the
objectives. By considering a
situation it may be possible
to identify opportunities to
improve.

Opportunity is not always
directly related to risk but it is
always related to the objectives.
By considering a situation it may
be possible to identify
opportunities to improve.

The Main Objectives of International Standards
• To provide confidence in the organization’s ability to
consistently provide customers with conforming goods and
services
• To enhance customer satisfaction
The concept of “risk” in the context of the international
standards relates to the uncertainty in achieving these
objectives
ISO 9001:2015 Risk & Opportunities
Dibagian mana ISO 9001:2015 –
menyebutkan dan/atau menekankan kepada : Risk/resiko

Introduction
• 0.1 General: “The risks associated with its context and objectives”
• 0.3 Process approach: “….with an overall focus on risk based thinking"
• 0.5 “Risk-based thinking”: “Risk is the effect of uncertainty on an
expected result and the concept of risk-based thinking has always been
implicit in ISO 9001”
• 0.6 Compatibility with other management system standards:
“Processes for planning and consideration of risks and opportunities”
Where is Risk Mentioned in
3. Terms and definitions
3.09 Risk: “effect of uncertainty on an expected result”
ISO 9001:2015 + IATF 16949 Risk & Opportunities

5 Leadership
5.1.2 Customer focus: “the risks and opportunities that can affect
conformity of products and services and the ability to enhance customer
satisfaction are determined and addressed”
6 Planning for the quality management system
6.1 Actions to address risks and opportunities
6.1.1
When planning for the quality management system, the organization shall
consider the issues referred to in 4.1 and the requirements referred to in 4.2 and
determine the risks and opportunities that need to be addressed to:
a) give assurance that the quality management system can achieve its intended
result(s);
b) prevent, or reduce, undesired effects;
c) achieve continual improvement.

4.4
Quality management system and its processes
The organization shall establish, implement, maintain and continually
improve a quality management system, including the processes needed and
their interactions, in accordance with the requirements of this International
Standard.
The organization shall determine the processes needed for the quality
management system and their application throughout the organization and
shall determine:
…
f) the risks and opportunities in accordance with the requirements of 6.1,
and plan and implement the appropriate actions to address them;
4 Context of the organization

6.1.2 The organization shall plan:
a) ..actions to address these risks and opportunities;
b) how to:
1) integrate and implement the actions into its quality management
system processes (see 4.4);
2) evaluate the effectiveness of these actions. Actions taken to
address risks and opportunities shall be proportionate to the
potential impact on the conformity of products and services
ISO 9001:2015 Risk & Opportunities
8 Operation
8.5.5 Post-delivery activities: “the risks associated with
the products and services”

Terdapat 36 persyaratan IATF yang
mempersyaratakan Pengendalian resiko
dalam proses sistem manajemen mutu

APAKAH RISK BASED THINKING
(RBT)/PEMIKIRAN BERBASIS RESIKO INI ?
1. A unique approach to management systems
certification
2. Takes certification to the next level and allows the
demonstration of compliance to the chosen
standard while building sustainable business
performance over time
3. All interested parties / stakeholders expect that
business owners must manage the full impact of
their operations – social, economic and
environment

Risk Based Thinking
o Evaluasi resiko dan peluang berdasarkan kondisi
perusahaan /Organization context
o Membuat Analisa tindakan terhadap resiko dan
peluang – akan tetapi tidak fokus “untuk membuat risk
management dengan model/alat bantu tertentu”
o ISO 31000/Risk Management – sebagai panduan bisa
dipergunakan (akan tidak diwajibkan/mandatory
digunakan dan diterapkan dalam system manajemen
mutu)

Risk Based Thinking
What the standard doesn’t require:
Remember: the standard DOES NOT prescribe a
methodology or require a documented process for
risk-based thinking.
Ultimately, it is up to an organization to
choose a suitable process or specific methodology
to address risk.
Meskipun demikian Core tools – sebagai bentuk risk
management diwajibkan digunakan dalam IATF

Risk Based Thinking
Choose Wisely…
(From ISO 31010):
• “it should be justifiable and appropriate to the situation or
organization under consideration;”
• “it should provide results in a form which enhances
understanding of the nature of the risk and how it can be
treated;”
• “it should be capable of use in a manner that is traceable,
repeatable and verifiable.”

Risk Based Thinking
• Risiko adalah efek ketidakpastian pada hasil yang
diharapkan
• ISO 9001: 2015 memasukkan risiko ke dalam
persyaratan untuk SMM
• Tingkat risiko ditentukan oleh organisasi
• "Pemikiran berbasis risiko/Risk Based Thinking"
mempertimbangkan risiko secara kualitatif
(dan kuantitatif) tergantung pada konteks
organisasi

Risk Based Thinking
• Sistem manajemen yang berfungsi dengan baik adalah awal
yang baik untuk membangun kinerja bisnis yang berkelanjutan
• Membantu memastikan pengiriman tepat waktu, tanpa cacat
dan mengurangi pemborosan
• Sistem manajemen kesehatan dan keselamatan kerja
memastikan keselamatan karyawan, mengurangi cuti sakit dan
mengurangi jumlah kecelakaan
• RBT (Risk Based Thinking) memfasilitasi pandangan yang lebih
luas untuk mengidentifikasi risiko paling kritis yang dapat
berdampak pada tujuan bisnis

Risk Based Thinking
o Identify what the risks and opportunities are in your organization
(hint: it depends on context)
o A key change in the 2015 revision is to establish a systematic approach
to risk, rather than treating it as a single component of a quality
management system. Note: ISO 9001:2015 does not require you to carry
out a full, formal risk assessment
o In previous editions of ISO 9001, a clause on preventive action was
separated from the whole. Now risk is considered and included
throughout the standard.
o By taking a risk-based approach, an organization becomes proactive
rather than purely reactive.

Risk Based Thinking
RBT follows the PLAN – DO – CHECK – ACT cycle
Building sustainable business performance requires that
organisations:
◦ Take a broader view, inside and outside the organisation
◦ Understand all relevant risks that could impact on
business objectives
◦ Incorporate these in the audit to get more knowledge on
the performance of the management system

Risk Based Thinking :
Risk & Opportunities
Key Concepts:
• Analyze and prioritize the risks and opportunities in your
organization
– what is acceptable?
– what is unacceptable?
• Plan actions to address the risks
– how can I avoid or eliminate the risk?
– how can I mitigate the risk?
• Implement the plan – take action
• Check the effectiveness of the actions
– does it work?
– Learn from experience – continual improvement

Bagaimana
RISK BASED AUTOMOTIVE PROCESS APPROACH AUDIT
Understand the organisation and its context, including the
identification of:
◦ long-term business targets
◦ most relevant stakeholders (interested parties), both
internal and external
◦ the most critical risks
Consider which risk could:
◦ Prevent reaching each of the long-term business targets
◦ Be managed by the organisations management system

o Prioritise your most critical risks and where to focus
the audit
o Define the focus area(s) for the audit
o During the audit, check how well the organisation’s
management system supports the defined focus
area(s)
o The focus area(s) provide structure audit, allowing
assessing what matter most
o The audit report is an immediate output which should
include a list of findings and performance of the
identified focus area(s)
Bagaimana

Bagaimana
Include an Executive Summary to provide quick insight
What is learnt from the audit can help the organisation
improve the MS and assist to:
◦ Identify mitigating actions to a broader set of challenges –
operational challenges as well as more long-term
objectives
◦ Laying a foundation for sustainable business performance
◦ Improve the organisation’s ability to respond to
stakeholder demands.

Bagaimana
o RBT is designed to help organisations to get more
out of every audit and start building sustainable
business performance
o it provides a broader view of the organisations
most critical risks, enabling the management
system to assist in mitigating them

Kenapa Risk Based Thinking (RBT) menjadi
model dasar Sistem Manajemen Mutu (SMM) ?
SMM yang Memperhatikan risiko dan peluang secara keseluruhan – akan
mengarahkan organisasi untuk :
• Meningkatkan kemampuan untuk memenuhi kinerja yang telah
ditentukan
• Hasil proses akan lebih konsisten
• Pelanggan semakin yakin menerima produk atau layanan akan sesuai
dengan harapan

KENAPA RISK BASED THINKING (RBT)/
PEMIKIRAN BERBASIS RESIKO MENJADI PILIHAN
DASAR SISTEM MANAJEMEN MUTU?
• To improve customer confidence and
satisfaction
• To assure consistency of quality of goods and
services
• To establish a proactive culture of prevention
and improvement
• Successful companies intuitively take a risk
based approach
ISO 9001:2015 will not automatically require
you to carry out a full, formal risk
assessment, or to maintain a “risk register”

KENAPA RISK BASED THINKING (RBT)/
PEMIKIRAN BERBASIS RESIKO MENJADI PILIHAN
DASAR SISTEM MANAJEMEN MUTU?
Key Points to Remember
• Risk Based Thinking = Proactive action rather
than only Preventative Action
• Risk Based Thinking is everybody’s business!
• Risk Based Thinking is not just the responsibility
of management
• Risk Based Thinking must become an integral part
of the organizational culture

SESSION 2
IATF 16949:2016, Clauses 4 – 6
◦ Organisation and its context
◦ Needs and expectations of interested parties
◦ Scope of the QMS
◦ Leadership and commitment
◦ Quality policy
◦ Quality objectives
◦ Organisational roles, responsibilities and authorities
◦ Actions to address risks and opportunities
◦ Quality objectives and planning to achieve them

SESSION 2
By the end of this session, you will be able to:
◦ Understand the requirements of IATF
16949:2016, Clause 4: Context of the
organisation
16949:2016, Clause 5: Leadership
16949:2016, Clause 6: Planning

Understanding the Organization and it’s Context
An organisation must determine:
◦ The internal and external issues which may impact the QMS (4.1)
◦ The needs, expectations and requirements of all interested parties
(4.2)
◦ These issues and applicability when setting scope of QMS (4.3)
◦ The processes needed, including the inputs and outputs, and
sequence and interaction (4.4.1)
◦ The risks and opportunities to be addressed in accordance with
clause 6.1 (4.4.1)
◦ The documented information to be maintained and retained (4.4.2)

Organisasi berubah dan berkembang untuk kemajuan
berkesinambungan
Organisasi harus memahami kondisi-nya : secara
internal serta pengaruh eksternal. Menentukan dari ke
–dua nya sebagai faktor untuk perkembangan
berkelanjutan (sustainability)
• Apakah bisa dihilangkan, dipindahkan, atau
dihindari.
• Melakukan tindakan pro-aktif untuk tindakan
pencegahan untuk menjamin mutu hasil dari proses
manajemen mutu.
• Melakukan perubahan dan peningkatan berdasarkan
perubahan dan perkembangan factor eksternal dan
kondisi internal dari organisasi/perusahaan.

ANALYZING THE EXTERNAL ENVIRONMENT
• Organisasi Anda mungkin sudah melakukan analisis
jenis ini
• Apakah Anda melakukan perencanaan strategis, riset
pasar, atau pembandingan yang mengidentifikasi
masalah eksternal yang sedang ditindaklanjuti dalam
sistem manajemen bisnis / kualitas Anda?
• Apakah itu menggerakkan Visi, Misi, Kebijakan Kualitas,
Perencanaan Strategis, Tujuan Bisnis, Penerapan
Kebijakan Anda, dll.?
• Can you demonstrate how you are doing it?

UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES
ANALISA DAN MEMAHAMI PIHAK PIHAK YANG BERKEPENTINGAN DENGAN ORGANISASI

PERENCANAAN STRATEGI PERUSAHAAN
DARI EVALUASI KONTEKS ORGANISASI DENGAN METODE RISK BASED THINKING
Putting all together of Context of the organization :
how become strategic action

Putting all together of Context of the organization :
how become strategic action

ANALYZING THE EXTERNAL ENVIRONMENT
Honda Global Strategy – taken from CSR report

Persyaratan yang ditetapkan dalam IATF 16494:2016
Please refer to ISO 9001:2015 requirements regarding Clause 4.1 and 4.2,
however 4.3 and 4.4 now have additional requirements:
◦ 4.3.1 Determining the scope of the quality management system – supplemental
 Section 8.3: …maintained as documented information (see ISO 9001, Section 7.5). (4.3.1)
 Ruang lingkup sistem manajemen mutu ditetapkan dan didokumentasikan.
◦ 4.3.2 Customer-specific requirements (CSRs)
◦ Customer-specific requirements shall be evaluated and included in the scope of the organization’s
quality management system
◦ Pemenuhan dan implemnetasi persyaratan spesifik milik pelanggan harus termasuk dalam ruang lingkup
manajemen mutu

QUALITY MANAGEMENT SISTEM SCOPE
 For organisations that:
a) needs to demonstrate its ability to consistently provide products
and services that meet customer and applicable statutory and
regulatory requirements, and
b) aims to enhance customer satisfaction through the effective
application of the system, including processes for improvement
of the system and the assurance of conformity to customer and
applicable statutory and regulatory requirements.

4.4.1.1 Conformance of products and processes
• The organization ......processes, including service parts ....., to all applicable
customer, statutory requirements (see Section 8.4.2.2) (4.4.1.1)

4.4.1.1 Conformance of products and processes
• The organization ......processes, including service parts ....., to all applicable customer,
statutory requirements (see Section 8.4.2.2) (4.4.1.1)
• See the relevant requirements of Honda SQAM – according to regulatory and staturory

4.4.1.2 Product safety
◦ The organization shall have documented processes for the management of product-
safety related products and manufacturing processes, which shall include but not be
limited to the following, where applicable
◦ NOTE: Special approval of safety related requirements or documents may beof safety related requirements or documents may beof safety related requirements or documents may beof safety related requirements or documents may be
required by the customer or the organization’s internal processesrequired by the customer or the organization’s internal processesrequired by the customer or the organization’s internal processesrequired by the customer or the organization’s internal processes. is an. is an. is an. is an
additional approval by the function (typically the customer) that is responsible toadditional approval by the function (typically the customer) that is responsible toadditional approval by the function (typically the customer) that is responsible toadditional approval by the function (typically the customer) that is responsible to
approve such documents with safetyapprove such documents with safetyapprove such documents with safetyapprove such documents with safety----related content.related content.related content.related content.

LEADERSHIP :
KEPEMIMPINAN DALAM
SISTEM MANAJEMEN MUTU
Is defined in ISO 9000:2015, 3.1.1, as the person or group
of people who directs and controls an organization at the
highest level (within the scope of the quality management
system). Top Management has the power to delegate
authority and provide resources within the organization.
Clause 5 of ISO 9001:2015 has three sub-clauses:
5. Leadership
5.1 Leadership and Commitment
5.2 Policy
5.3 Organizational Roles,
Responsibilities, and Authorities
Top Management

LEADERSHIP :
PERAN KEPEMIMPINAN DALAM SISTEM MANAJEMEN MUTU

LEADERSHIP :
KEPEMIMPINAN DALAM SISTEM MANAJEMEN MUTU
Top management must:
◦ Take accountability for the effectiveness of the QMS (5.1.1a)
◦ Ensure the policy and objectives are compatible with the context
and strategic direction of the organisation (5.1.1b)
◦ Ensure the integration of the QMS into the business processes
(5.1.1c)
◦ Promote the process approach and risk-based thinking (5.1.1d)
◦ Ensure necessary resources are available (5.1.1e)
◦ Communicate the importance of QMS requirements (5.1.1f)
◦ Ensure QMS achieves intended results (5.1.1g)
◦ Engage, direct and support those who contribute to the
effectiveness of the QMS (5.1.1h)

LEADERSHIP :
◦ Promote improvement (5.1.1i)
◦ Support other managers to demonstrate leadership (5.1.1j)
◦ Demonstrate leadership and commitment to customer focus (5.1.2)
◦ Establish, implement and maintain a quality policy that is appropriate to
the context and supports the strategic direction (5.2.1)
◦ Ensure that responsibilities and authorities for roles are assigned,
communicated and understood including those for:
• Ensuring the QMS conforms to ISO 9001 (5.3a)
• Reporting on performance of QMS (5.3c)
• Promoting customer focus (5.3d)
◦ Review the QMS to ensure alignment with strategic direction (9.3.1)

LEADERSHIP :
5.1.1.1 Corporate responsibility
The organization shall define and implement
corporate responsibility policies,
including at a minimum an anti-bribery
policy, an employee code of conduct,
and an ethics escalation policy (“whistle-
blowing policy”).
Apabila terdapat persyaratan pelanggan
spesifik mengenai anti bribery dan whistle
blowing – maka harus dipenuhi

LEADERSHIP :
5.1.1.3 Process owners
Top management shall identify process owners who are responsible for managing the
organization’s processes and related outputs. Process owners shall understand their
roles and be competent to perform those roles (see ISO 9001, Section 7.2)
Pemilik Proses adalah orang yang segera bertanggung jawab untuk menciptakan,
mempertahankan, dan meningkatkan proses tertentu, serta, bertanggung jawab
atas hasil proses.
Pemilik proses biasanya seseorang dalam manajemen, bukan tim atau komite. Anda
memerlukan satu titik kontak yang bertanggung jawab untuk keseluruhan proses.
Tentu saja, pemilik proses dapat membentuk pemimpin proses dan tim untuk
membantu mengatur, mengoperasikan, dan mendukung proses tersebut.

LEADERSHIP :
Top management shall review the product realization processes effectiveness and
efficiency of the quality management system and support processes to evaluate and
improve their effectiveness and efficiency the organization’s quality management system.
The results of the process review activities shall be included as input to the management
review (see Section 9.3.2.1.).
5.1.1.2 Process effectiveness and efficiency
• Efektivitas dan efisiensi proses adalah konsep melakukan proses secara optimal.
Diterapkan untuk semua proses dalam sistem manajemen mutu – tidak hanya produksi.
• Efektivitas mengacu pada kemampuan proses untuk menghasilkan keluaran seperti yang
diharapkan.
• Efisiensi mengacu pada kemampuan Anda untuk mengoptimalkan sumber daya dalam
menghasilkan keluaran proses seperti yang diharapkan.
• Organisasi tidak dapat mengabaikan istilah 'efisiensi' dan 'efektivitas' untuk meningkatkan
produktivitas serta meningkatkan layanan pelanggan, keduanya sangat penting. Efisiensi
adalah melakukan hal-hal yang benar; efektivitas adalah melakukan hal yang benar.

Flash Back – materi sebelumnya
Keuntungan perusahaan didapat dari
Harga produk – Total beaya (beaya produksi + beaya mutu)
Sumber : quality cost – Juran quaity control handbook

LEADERSHIP :
◦ 5.3.1 Organizational roles, responsibilities, and authorities – supplemental
◦ Assign personnel with the responsibility and authority
◦ Document assignments
◦ … capacity analysis, logistics information, customer scorecards, and
customer portals

LEADERSHIP :
5.3.2 Responsibility and authority for product
requirements and corrective actions
NOTE: Due to the process design in some
industries, it might not always be possible to
stop product immediately. In this case, the
affected batch must be contained and shipment
to the customer prevented
CSR – Honda SQAM –
section 2-3 Designation of Quality Representative

The requirements of interested parties have to be considered (6.1.1)
Determine the risks and opportunities (6.1.1)
Plan actions to address risks and opportunities (6.1.2)
Establish objectives at relevant functions, levels and processes
(6.2.1)
Planning to achieve objectives must include resources required,
responsibilities, completion dates and evaluation (6.2.2)
Any changes to the QMS must be carried out in a planned and
systematic manner (6.3)
6 - Planning
Perencanaan

6 - Planning
Perencanaan
6.1 Actions to Address Risks and Opportunities
6.1.1 :
When planning for the quality management system (QMS), consider the issues in
clause 4.1, and the requirements in 4.2.
Determine the risks and opportunities that need to be addressed to:
• give assurance that the QMS can achieve its intended results;
• enhance desirable effects;
• prevent, or reduce, undesired effects;
• achieve improvement.
6.1.2 (untitled)
plan actions to address these risks and opportunities; plan how to:
integrate and implement the actions into QMS processes (see 4.4);
evaluate the effectiveness of these actions.

6 - Planning
Perencanaan
6.1.2.1 Risk analysis
◦ The organization shall include in its risk analysis, at a minimum,
lessons learned from product recalls, product audits, field returns,
complaints, scrap, and rework
◦ The organization shall retain documented information as evidence
of the results of risk analysis
6.1.2.2 Preventive action – (ISO/TS 8.5.3)
◦ The organization shall establish a process to lessen the impact of
negative effects of risk including the following:
d) documented information of action taken
f) utilizing lessons learned to prevent recurrence in similar
processes (see Iso 9001, Section 7.1.6)

6 - Planning
Perencanaan
Global Risk management – Honda –
sebagai bagian dari sustainability
management : kelangsungan
bisnis/bagian dari business continuity
management lihat selengkapnya di
https://global.honda/

6 - Planning
Perencanaan
Global Risk management – Honda –
sebagai bagian dari sustainability
management : kelangsungan
bisnis/bagian dari business continuity
management lihat selengkapnya di
https://global.honda/content/dam/site/glob
al/about/cq_img/sustainability/report/pdf/
2019/Honda-SR-2019-en-036-038.pdf

6 - Planning
Perencanaan
Commit and Mandate
•Policy Statement
•Standards
•Guidelines
•RM Plan and RM Process
•Assurance Plan
Communicate & Train
•Stakeholder analysis
•Training needs analysis
•Communication strategy
•Training strategy
•Roles and Reporting
Structure & Accountability
•Board RM Committee
•Executive RM Group
•RM Working Group
•Facilitator for Risk Management
•RM Champions
•Risk and Control Owners
Review & Improve
•Control assurance
•RM Plan progress
•RM Maturity Evaluation
•RM KPIs
•Benchmarking
•Governance reporting Framework Continuous
Improvement Cycle
Management Information System
-Risk Registers -Treatment Plans
-Assurance Plan -Reporting templates
Framework Implementation
Establish context
Identify risks
Analyse risks
Evaluate risks
Treat risks
Communicateandconsult
Monitorandreview
Risk assessment
Process for Managing Risk
Framework
Implementatio
n
FrameworkContinuous
ImprovementCycle

6 - Planning
Perencanaan
Mengambil tindakan untuk mengatasi risiko dan peluang yang
proporsional dengan dampak potensial pada kesesuaian produk dan
layanan.
CATATAN 1:
Opsi untuk mengatasi risiko dan peluang dapat mencakup:
• menghindari risiko;
• mengambil risiko untuk mengejar peluang;
• menghilangkan sumber risiko;
• mengubah kemungkinan atau konsekuensi; berbagi risiko; atau
• mempertahankan risiko dengan keputusan berdasarkan informasi.

6 - Planning
Perencanaan

LOGO PROCESS SI: MANAGE SUPPLIERS Owner: Mr Z Date: 11/2/2016
Clients of the
process
Colleagues
Other processes
Process outputs
Supply sites with products and serviced including
manufacturing equipment in order to produce and supply
clients at optimal QCD
Suppliers to the
process
Other processes
External suppliers
Measure customer satisfaction Measure internal performance Process reviews
Reduced purchase price
Reduced number of suppliers
Number of invoices settled on time
Monthly: Indicators and action plans
Annual: Overall review
Description of process Process analysis
Inputs Elements Outputs Actions Equipment Indicators Instructions
Purchase policy
M1)
Purchase
requests and
specifications
Request accepted All
Purchaser
Purchaser
Purchaser
Quality Technician
Computer system
QDD
Procedure XXX
Control plan
Purchase date Request for quote
Offers Supplier chosen
(data base
uploaded)
Order
Products and
services +
Delivery notes
Incoming material
report (Accounts)
Invoice (Supplier) Supplier paid
What is missing to check that
the process is under control?

Example risk analysis
(continued)
LOGO PROCESS SI: MANAGE SUPPLIERS Owner: Mr Z Date: 11/2/2016
Clients of the
process
Colleagues
Other processes
Process outputs
Supply sites with products and serviced including
manufacturing equipment in order to produce and supply
clients at optimal QCD
Suppliers to the
process
Other processes
External suppliers
Measure customer satisfaction Measure internal performance Process reviews
Reduced purchase price
Reduced number of suppliers
Number of invoices settled on time
Monthly: Indicators and action plans
Annual: Overall review
Description of process Process analysis Risk analysis
Inputs Elements Outputs Actions Equipment Indicators Instructions Risk
Control and
interaction
Action
Purchase policy
M1)
Purchase
requests and
specifications
Request accepted All
Purchaser
Purchaser
Purchaser
Quality Technician
Computer system
QDD
Procedure XXX
Control plan
Requirement
inadequately
defined
Financial and
risk supplier
imposed buy
customer
Project review
Supplier
assessment Update
contingency
plan
Purchase date Request for quote
Offers Supplier chosen
(data base
uploaded)
Order
Products and
services +
Delivery notes
Incoming material
report (Accounts)
Invoice (Supplier) Supplier paid
Purchase request
Consultation with
suppliers
Selection & choice of
suppliers
Order and manage order
Receptionquality and
quantity
Manage invoices and
pay suppliers
• Analyse risks
• Identify the way they are
controlled
• Interaction with other
processes
• Identify actions to control risks
• Process improvement

6 - Planning
Perencanaan
6.1.2.3 Contingency plans – (ISO/TS 6.3.2)
◦ The organization shall:
a) identify and evaluate internal and external risks to all manufacturing processes and
infrastructure equipment essential to maintain production output and to ensure that
customer requirements are met
b) .......according to risk and impact to the customer
c) prepare contingency plans for continuity of supply in any relevant event.....
d) include, as a supplement to the contingency plans, a notification process to the customer
and other interested parties for the extent and duration of any situation impacting customer
operations
e) periodically test the contingency plans for effectiveness (e.g. simulations, as appropriate)
e) conduct contingency plan reviews (at a minimum annually) using a multidisciplinary team including
top management, and update as required
f) document the contingency plans and retain documented information describing any revision(s),
including the person(s) who authorized the change(s)

6 - Planning
Perencanaan
a) – d) (…)
e) periodically test the contingency plans for effectiveness (e.g. simulations,
as appropriate); cybersecurity testing may include a simulation of a cyber-
attack, regular monitoring for specific threats, identification of dependencies
and prioritization of vulnerabilities. The testing is appropriate to the risk of
associated customer disruption; Note: cybersecurity testing may be managed
internally by the organization or subcontracted as appropriate
6.1.2.3 Contingency plans – (ISO/TS 6.3.2)
SI number SI#17 issued in October 2019, effective January 2020

6 - Planning
Perencanaan
6.1.2.3 Contingency plans – (ISO/TS 6.3.2), continued
◦ The organization shall:
◦ The contingency plans shall include provision to validate that the manufactured
product continues customer specifications after the re-start of production
following an emergency in which production was stopped and if the regulator
shutdown processes were not followed
6.2.2.1 Quality objectives and planning to achieve them – supplemental –
(ISO/TS 5.4.1.1)
◦ Top management shall ensure that quality objectives to meet customer
requirements are defined, established, and maintained for relevant functions,
processes, and levels throughout the organization
◦ Results of the organization’s review regarding interested parties and their relevant
requirements considered when the organization establishes its annual (at a
minimum) quality objectives and performance targets (internal and external).

6 - Planning
Perencanaan menggunakan konsep
Risk Based Thinking

6 - Planning
• Menjadi program manajemen resmi
• Sebelum perencanaan dapat dimulai, tim harus merencanakan
upaya dan menyiapkan dokumen yang dihasilkan
• Champion: manajer tingkat tinggi untuk mendukung,
mempromosikan, dan mendukung temuan proyek
• Manajer proyek: memimpin proyek dan memastikan proses
perencanaan proyek yang baik digunakan, rencana proyek
yang lengkap dan bermanfaat dikembangkan, dan sumber daya
proyek dikelola dengan bijaksana
• Anggota tim: harus manajer atau perwakilan mereka dari
berbagai komunitas yang diminati: bisnis, TI, dan keamanan
informasi
• Simulasi untuk melihat efektifitas pelaksanaannya –
direncanakan secara berkala/annual based
• Manajemen melakukan evaluasi dari hasil simulasi ini untuk
menentukan langkah selanjutnya

6 - Planning
Contigency Plan dalam IATF 16949:2016

6 - Planning
Contigency Plan dalam IATF 16949:2016 : Relevan thema lainnya – Organisasi harus berani
melihat ke aspek relevan lainnya berdasarkan kontek organisasinya

6 - Planning

6 - Planning
Perencanaan
Global Risk management & Crisis
Management – Honda – sebagai bagian
dari sustainability management :
kelangsungan bisnis/bagian dari business
continuity management lihat
selengkapnya di https://global.honda/

AK H IR - M O D U LE 2
IATF 16949:2016
S ISTEM M AN A JEM EN M U TU IN D U STR I
OTO M OTIF AU TO M OTIV E Q UALITY
M AN AG EM EN T SYSTEM

IATF 16949 Training Presentation

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IATF 16949 Training Presentation