Interpretation and documentation iso 9001

British Standard Institution Learning Academy

ISO 9001:2015 INTERPRETATION & DOCUMENTATION

COURSE

8-9 Oktober 15

Dewi AlmitrasariLead Auditor & Trainer

Copyright © 2015 BSI. All rights reserved.

Benefits to you!


3

Welcome!


4

Delegate Introductions

Introductions

Dewi Almitra Sari


5

Course Aim

To gain an understanding of effective quality management, by using a systematic framework to:A) Consistently provide products or

service that meet requirementsB) Enhance customer satisfaction

C) Develop effectiveness of documentation system


6

Learning Objectives

Have the skills to develop documentation : • process mapping• documented information

such as procedure and supporting document

……QMS shall establishing the documented information for

the effectiveness (Clause 7.5, ISO FDIS 9001:2015)

• The history and development of ISO/FDIS 9001

• What is a Quality Management System (QMS)

• The benefits of a QMS

• The terms and definitions used

• Key concepts, principles and structure

• The main requirements of ISO/FDIS 9001:2015 and how to implement

KNOWLEDGE SKILLS


7

Solution & Result...

01/05/2023

1 2 3 4

Overview Knowledge Identification

Documentation

The Need for Quality

Management System

Understanding the

requirements of the

standard is your essential starting point to working

with a management

system.

Develop your expertise to identify the

document and other to

comply the requirement

Discover how you

can develop the documentation

system

training journey to excellence... (2 days course)


8

• Principle of QMS• Terminology

(Workshop 1)• Concept of Quality

Closing

Module 1

Module 3ISO 9001 - General

Introduction Training Agenda 2 days Course

Module 2Overview

• Historical of ISO 9001• ISO 9000, ISO 9001 &

ISO 9004

Module 4Interpretation &

Documentation of Context Organisation

• Interested Party• Scope• Process Mapping (Workshop 2)


Documentation of Resources

• People• Infrastructure• Process Environment• Monitoring & Measurement• Knowledge Management)• Competence• Awareness• Documented Information(Workshop 4


Documentation of Leadership

• Commitment• Quality Policy• Role & Responsibility


Documentation of Operation

• Planning and provision of services ((Workshop 5)

• Control of external providers• Release & Control of Non Conforming


Documentation of Performance Evaluation

• Customer Satisfaction• Internal Audit• Management Review


Documentation of Improvement

• Improvement• Nonconformity & Corrective action• Continual Improvement)


Documentation of Planning

• Risk Management

(Workshop 3)• Quality Objective• Management of Change


9

Time Table08 October 201508.00 Opening & Introduction 08.20 Module 1 : Concept of Quality09.00 Module 2 : QMS Overview & Workshop 109.40 Module 3 : QMS Historical10.00 Break10.15 Module 4 : Context Organisation & Workshop 212.00 Ishoma13.00 Module 5 : Leadership14.00 Module 6 : Planning and workshop 315.00 Break15.15 Continued with module 616.30 End of Day 1 course


10

Time Table09 October 201508.00 Review of day 1 materi08.15 Module 7 : Resources and workshop 410.00 Break10.15 Continued with module 711.00 Module 8 : Operation12.00 Ishoma13.00 Continued with module 8 and workshop 515.00 Break15.15 Module 9 : performance Evaluation16.00 Module 10 : Improvement16.30 End of course


11

Course Structure

Course Format:• Activities• Classroom discussions

Materials:• Delegate workbook• Loan copy of ISO 9001


12

British Standard Institution Overview


13

Who is BSI?

05/01/2023

• Leading Global Standards Creation Body: British, European, ISO, Public, Private

• The UK National Standards Body: The source of British Standards

• Specialist Focus on Standards Creation, Training and Certification

• Global Network: 72,000 clients in 150 countries worldwide including governments, global brands and

SME’s

• Experienced: The world’s first National Standards Body established in 1901 and a founding member of

ISO

• Thought Leaders: Shaped the world’s most adopted standards, incl. ISO 9001, ISO 14001, OHSAS

18001

• Trusted: We’re a Royal Charter Company, reinvesting profits back into our business to improve our

clients’ experience


14

BSI’s end-to-end solutions make excellence a habit

R i s k M a n a g e m e n t S t a n d a r d sS u s t a i n a b i l i t y S t a n d a r d s

O p e r a t i o n a l P e r f o r m a n c e S t a n d a r d s

Together with >10,000 independent experts,

BSI leads in the development and

maintenance of global standards

• Public Standards - PAS• British Standards - BS• European Standards -

EN• ISO Standards

Shape

We share our standards and

guidance documents in many formats,

from paper to PDF or organization-wide

licenses

• Online Standards Portal

• Network Licenses

Share

Our tutors transfer the knowledge and

skills needed to embed excellence

• In-Company Training• Public Training• Internal & Lead Auditor Training

• Self Assessment tools

• Gap Analysis

Embed

Our assessors give you proven ways to measure, improve

and confidently promote your organization

• Management Systems Certification

• Gap Analysis• Verification Services• Supplier Certification• 2nd Party Assessment

• Self Assessment Tools

• Product Certification• Kitemark & CE

marking

Assess

We support you with the knowledge and business tools you need to continually

improve

• Entropy™ Software • BSI Excellerator™

Report• Supply Chain

Solutions• Six Sigma Training • Business Improver

Training

Support


15

Standardisasi

Sertifikasi

Accreditation Body

Certification Body

Organization

Accredits

International Accreditation ForumCertified once, accepted everywhere

UK

USA


16

BSI Standards – World StandardsSince 1901 BSI has worked with industry to build consensus and develop standards of

excellenceYear British

StandardISO Standard

1987 BS 5750 ISO 9001 (Quality Management)

1992 BS 7750 ISO 14001 (Environmental Management)

1995 BS 7799 ISO/IEC 27001 (Information Security)

1996 BS 8800 OHSAS 18001 / AS/NZS 4801 (Occupational Health & Safety)

2000 BS 8600 ISO 10002 (Customer Satisfaction)

2002 BS 15000 ISO/IEC 20000 (IT Service Management)

2002 TS 16949 ISO/TS 16949 (Automotive)

2009 BS 16001 ISO 50001 (Energy Management)

2009 BS 5750 (based) AS 9100 (Aerospace)

2012 BS 25999 ISO 22301 (Business Continuity)

2012 BS 8901 ISO 20121 (Sustainable Events)


Concept of Quality

1


1818

MUTU


19

Quality Management /

Manajemen Mutu

Quality Assurance /

Jaminan MutuQuality Control/ Kendali Mutu

Quality ? Mutu ?


20

Apa itu Mutu?

• Memenuhi dan melebihi harapan dan kebutuhan pelanggan, dan peningkatan berkelanjutan

William Edwards

Deming (1900-1993)

• Mutu berarti kesesuaian terhadap persyaratan

Philip Bayard Crosby (1926-

2001):

• Mutu berarti kesesuaian dengan penggunaan

Joseph Moses Juran (1904 –

2008)

• Mutu berarti kepuasan pelangganKaoru Ishikawa (1915 – 1989)


21

Evolusi Sistem Manajemen Mutu

Non Quality Culture

Quality Inspection

Quality Control

Time

Q Performance

ZERO DEFECT

ZERO DEFECT CONTINUOSLY

ZERO DEFECT CONTINUOSLY & CUSTOMERS SATISFCATION Quality

Assurance

CUSTOMERS SATISFCATION CONSISTENTLYQUALITY

MANAGEMENT

(ISO 9001:2008)

ZERO DEFECT CONTINUOSLY & INTERESTED PARTIES SATISFCATION

(ISO 9001:2015)SUSTANAIBILITY

COMPLIANCE

PERFORMANC E


22

comprehensive portfolios ensure your corporate reputation remains secure


23

Key terms and definitionsBS EN ISO 9000

BSI British Standards

Qualitymanagement

systems – Fundamental

sand

vocabulary

Management ?“Coordinated activities to direct and

control an organization”

Quality Management ?“Management with regard to quality”

Quality Management System ?

“Management system with regard to quality”


24

Workshop 1a

15 minutesClick here to

start

Terms and Definitions


25

Sistem manajemen

Integrasi dari keseluruhan sistem manajemen yang meliputi struktur organisasi, rencana kegiatan,

tanggung jawab, prosedur, proses dan sumber daya untuk pengembangan, penerapan, pencapaian dan

pemeliharaan kebijakan atau arah perusahaan/organisasi.

VISI


26

VISI & MISI

Plan Do

CheckAction

KEBIJAKAN

SASARAN/TARGET

STRATEGI

SISTEM DOKUMENTASI

PENERAPAN

PROGRAM

PEMANTAUAN, EVALUASI & TINDAK

LANJUT

Kemana tujuan kita ?

Uraian dari visi & misi ?

Indikator pencapaian visi & misi ?

Rencana Manajemen Mutu

Metode pencapaian sasaran : prosedur, juklak, juknis, form dll


27

Mengapa kita perlu sistem ?


28

Integrasi = Keterkaitan

TUJUAN

• SASARAN MUTU• PROSES

• DOKUMENTASI


29

Personel• Tg. Jawab&wewenang• Kompetensi/Kualifikasi

• Pelatihan• Record

• Ketersediaan

Peralatan• Kebutuhan

• Ketersediaan• Kemampuan• Pemeliharaan

• KondisiPROSES

Kondisi lingkunganPenetapan

Pengelolaan

Material• Spesifikasi

• Ketersediaan• Penyimpanan

• Pengadaan

Informasi/Metode• Kebutuhan• Spesifikasi

• Akurat• Analisa

• Komunikasi• Ketersediaan

VISI

HARAPAN CUSTOME

RKEBIJAKAN &

SASARAN, PROGRAM

PLAN DO

ACTION CHECK


30

Pengukuran efektifitas sistem manajemen mutu

Sasaran mutu organisasi

Hasil pencapaian

% 100 75 50 25 0

Peningkatan


Management Principle

2


32

Key concepts : Management Principles

Customer Focus Leadership Engagemen

t of PeopleProcess

ApproachImproveme

nt

Evidence- based

Decision Making

Relationship

Management


33

“Organisasi tergantung pada pelanggan”

“Persyaratan Pelanggan”

Menetapkan harapan pelanggan sekarang dan akan datang”

Prinsip 1:Customer Focus / “Fokus Pelanggan”


34

Prinsip 2:Leadership /

Kepemimpinan

Pemimpin harus menetapkan keseragaman tujuan dan arah organisasi.

Harus menciptakan kesadaran semua orang untuk ikut serta terlibat mencapai

sasaran


35

• Setiap orang di setiap level adalah bagian penting dari organisasi.

• Keterlibatan penuh dari karyawan sangat menguntungkan bagi organisasi.

Prinsip Ke-3 Engagement of

people


36

Hasil yang diinginkan dapat dicapai lebih efisien bila sumber daya dan kegiatan yang terkait dikelola sebagai

suatu proses.

Identifikasi, pemahaman dan pengelolaan suatu sistem dari proses-proses yang saling berhubungan untuk mencapai sasaran yang ditetapkan meningkatkan

efektifitas dan efisiensi organisasi.

Prinsip Ke-4 Pendekatan

proses


37

Key concepts : Process Approach• A Coherent System:

• Understanding

requirements

Intended results Consistent,

predictable resultsMeeting requirementsCustomer satisfaction

Activities understoodand managed asinterrelated processes

Processes adding valueProcesses providing effective performanceImprovements (through evaluation) of data/informationPDCA (process) methodology (Fig. 2)

(Interactions)

(Outputs)(Inputs)

Process


38

Peningkatan berkelanjutan haruslah menjadi sasaran tetap dari organisasi

Prinsip Ke-5 Peningkatan


39

Pengukuran efektifitas sistem manajemen mutu

Sasaran mutu organisasi

Hasil pencapaian

% 100 75 50 25 0

Peningkatan


40

Keputusan yang efektif adalah yang berdasarkan pada analisa terhadap data dan

informasi.

Prinsip Ke 6Pendekatan Fakta/bukti untuk

keputusan


41

Organisasi dan pemasoknya selalu tergantung satu sama lain dan hubungan yang saling menguntungkan meningkatkan kemampuan dari kedua belah pihak untuk menghasilkan nilai tambah yang lebih besar.

Prinsip Ke-7 Relationship Management


42

Workshop 1b


start

Quality Management Principle


ISO 9000 Family

3


44

ISO 9001 – History

BS 5750: Part 1 : 1987ISO 9001 – 1987EN 29001 - 1987

British StandardQuality systemsPart 1. Specification for design/development,production, installation and servicing

BSI

BS 5750: Part 2 : 1987ISO 9002 – 1987EN 29002 - 1987

British StandardQuality systemsPart 1. Specification for productionand installation

BS 5750: Part 3 : 1987ISO 9003 – 1987EN 29003 - 1987

British StandardQuality systemsPart 1. Specification for final inspectionand test

BSID & DPellentesque mollis

felis dolor, quis aliquet sapien

dapibus tempus lectus. Nulla sed posuere velit, ut gravida nibh.


45

ISO Standards for Quality Management

BS EN ISO 9004


Managing for the

sustainedsuccess of anorganization

—A quality

managementapproach

BS EN ISO 9000


Qualitymanagemen

tsystems –

Fundamentals

andvocabulary

BS EN ISO 9001

BSI Standards Publication

QualityManageme

ntsystems –

Requirements


46

Evolusi Seri ISO 9000

Sejarah perubahan ISO 9001:

1st edition :ISO 9001:1987ISO 9002:1987ISO 9003:1987

2nd edition :ISO 9001:1994ISO 9002:1994ISO 9003:1994

3rd edition :ISO 9001:2000

4th edition :ISO 9001:2008

BS 5750 Part 2:1979

5th edition :ISO 9001:2015

BS EN ISO 9004 BSI British

Standards

Managing for the sustained success of

anorganization — A

qualitymanagement

approach

BS EN ISO 9000 BSI British

Standards

Quality managementsystems –

Fundamentalsand vocabulary

BS EN ISO 9001

BSI Standards Publication

Quality Management systems – Requirements


47

Accredited Certification

Accreditation Body

Certification Body

Organization

Accredits BSI, or esteemed

competitor

UKAS, or equivalent local national body

Personnel Certification Body

eg IRCA

AuditorUser

Audits

Certificates

Training Course, Tutor,

Training Body

Accredits

Trains

International Accreditation ForumCertified once, accepted everywhere Establishe

sMultilateral Recognition Arrangements

Mandatory Documents


48

Nama Perusahaan dan alamat

Ruang Lingkup aktifitas

Badan sertifikasi dan lembaga yang

mengakreditasi

Tanggal penerbitan dan masa berlakuk

sertifikat


49

Receive Manual & Procedure

Stage 1Audit

CorrectiveActions

Pre-Audit

CorrectiveAction

Stage 2Audit

CorrectiveActions

Follow-up audit

6-monthlySurveillance

Audit

CorrectiveActions

Follow-up audit

3 year

major

Y

Renewal Certification Process

CERTIFICATION PROCESS – ISO 9001

Min. 3 weeks before audit

OPTIONAL

majormajor

Max.3

months

N

Y Y

Max.3

months


50

Clause of ISO 9001:2015

05/01/2023

1

2

3

4

5

6

7

8

9

10

Scope

Normative references

Terms and definitions

Context of the organization

Leadership

Planning

Support

Operation

Performance evaluation

Improvement

1

2

3

4

5

6

7

8

9

10


51

1) Scope

2) Normative references

3) Terms and definitions

cites ISO 9000:2015 Quality Management Systems – Fundamentals and vocabulary as indispensable for its application

this particular Management System Standard (MSS) is addressed, and this includes the ‘intended result(s)’ of the application of this Standard. These have already in the main been addressed through the promotion of the process approach, namely:• Consistent provision of products and services that meet

customer and applicable statutory and regulatory requirements (legal requirements)

• ‘Intended outcome’ is that which is ‘intended’ as a result of the application of the standard, or process etc.

• ‘Expected outcome’ is that which is ‘expected’ by interested parties


52


Context of OrganisationClause 4 - ISO 9001:2015

4


54

Clause 4: Context of the Organization (1)Understanding the organization and its context


55

Understand the ‘Context of your Organization’

Intended result(s) of QMS

Requirements of these

interested parties

Purpose and

strategic direction

Boundaries and

applicability (Scope)

External and

internal issues

Interested parties

relevant to the QMS

Organization

Products and

services

Applicability

Determine:


56

Clause 4: Context of the Organization (2)4.2. Understanding the needs and expectations of interested parties

CitizensCustomers

DistributorsShareholders

InvestorsOwners

InsurersGovernment

RegulatorsRecovery service

suppliers

The OrganizationManagement• Top Management• Those accountable

for Quality policy and implementation

Those who implement and maintain the QMS• Those who maintain

QMS and risk procedures

Other StaffContractors

CompetitorsMediaCommentatorsTrade groupsNeighborsPressure groupsEmergency servicesOther response agenciesTransport servicesStaff dependents


57

Clause 4: Context of the Organization (3)

• 4.3. Determining the scope of the QMS

• 4.4. QMS and its Processes


58

Organisasi harus:

• mengidentifikasi proses-proses yang diperlukan• menetapkan tahapan dan interaksi dari proses-proses• menetapkan kriteria dan metoda untuk menjamin operasi dan

pengendalian• menjamin ketersediaan dari sumber daya dan informasi • memonitor, mengukur dan menganalisa proses-proses• menerapkan tindakan yang dibutuhkan untuk mencapai hasil yang

direncanakan dan peningkatan berkesinambungan.

Peta Proses

• 4.4. QMS and its Processes


59


60

Key concepts : Process

With what?(resources)

Outputs? (what,to whom)

What results?(monitoring, measurements, performance indicators)

Inputs? (what, from whom)

How done?(criteria, methods/controlsdocumentation)

With who?(responsibilities,authorities)

PROCESS


61

Key concepts Process Approach• A Coherent System:

• Understanding

requirements

Intended results Consistent,

predictable resultsMeeting requirementsCustomer satisfaction

Activities understoodand managed asinterrelated processes

Processes adding valueProcesses providing effective performanceImprovements (through evaluation) of data/informationPDCA (process) methodology (Fig. 2)

(Interactions)

(Outputs)(Inputs)

Process


62

Representation of the structure of this International Standard in the PDCA cycle

Leadership (5)

Support and Operation

( 7,8)

Improvement (10)

Planning (6)Performance evaluation

(9)

Plan Do

CheckAct

Quality Management System (4)

Organization and its context

(4)

Customer requirement

s

Needs and expectations of relevant interested parties (4)

Customer satisfaction

Products and

services

Results of the QMS


63

Contoh Generik Business ProcessCalon Mahasiswa

Bagian Administrasi dan Akademik Kemahasiswaan

Pendidikan & Pengajaran

Workshop Laboratorium

Perpustakaan

Lulusan,Industri, Masyarakat

Penelitian dan Pengabdian Pada

Masyarakat

FungsiPenjaminan

Mutu

FungsiMIS

FungsiPerbaikan dan

Perawatan

FungsiPublikasi

Bg Umum, Administrasi

dan keuangan

Business process mapping sebagai peta aliran fungsi untuk menjelaskan interaksi antar fungsi dan menjadi fondasi dalam menetapkan key performance indikator yang efektif

dengan berlandaskan kaidah “next process is our customer” dan kaidah “quality built by every proceses within organization”


64

Contoh Generik Context Diagram

Prosedur Proses

Belajar Mengajar

PEN-01

Prosedur Proses

Belajar Mengajar

PEN-01

Prosedur Bimbingan dan Administrasi Tugas Akhir

PEN-04

Prosedur Bimbingan dan Administrasi Tugas Akhir

PEN-04Prosedur Pelaksanaan

dan Evaluasi Ujian Semester

PEN-03

Prosedur Pelaksanaandan Evaluasi Ujian

Semester

PEN-03

Perpustakaan Laboratorium Workshop

Bagian Akademikdan AdministrasiKemahasiwaan

Unit MISUPT Perbaikandan Perawatan

Unit Publikasi

Bg Umum, Administrasi

dan keuangan

P3M

Review dan Improvement

Process

Context Diagram adalah menjadi landasan penyusunan prosedur yang efektif.Prosedur yang efektif adalah prosedur yang dibangun bukan berdasarkan klausul ISO tapi sebuah prosedur yang disusun dari nature of business proses organisasi yang disempurnakan untuk memastikan compliance

dengan ISO Requirement.


65

Business Process

Order Processing

Logistics

LitbangPlanning

Umum

QA, MR

CP-01

CP-02

PP-01

RID-01

SP-01

SP-02

SP-03

WI-XX-01(PenerimaanMhs baru )

WI-XX-02(Pembuatan

Kartu Tanda Peserta Test)


66


67

<Process > < Procedure> < W.I. >

Human resource management process

Equipment control procedurePurchasing procedure

Production procedureInspection procedure

Purchasing information controlinstruction

Supplier evaluation criteriaProducts inspection criteriaPurchasing criteria

Inquiry, negotiation and comparison of price

Sales marketing process

Production management process

Design and research process

Financial management process

ISO

900

1 Q

ualit

y M

anag

emen

t Sys

tem

Structure of quality management system and documentation

Sample 1


68

ContohMATRIKS KORESPONDENSI "DOKUMENTASI - STANDARD"

No Departemen/ Proses

Nama Dok.

No Dok.

Klausul ISO 9001Prosedu

r Regulasi …….


LeadershipClause 5 - ISO 9001:2015

5


70

5. Leadership

5.1. Leadership and commitment

Leadership and commitment for the

quality management

system

Customer focus

5.2. Quality policy

5.3. Organizational roles,

responsibilities and authorities


71

5.1 LEADERSHIP & COMMITMENT


72

FOKUS KE PELANGGAN

• Persyaratan pelanggan dan peraturan yang berlaku telah ditetapkan, dipahami dan dipenuhi secara konsisten

• Resiko dan peluang yang dapat berakibat pada pelayanan & produk serta kemampuan untuk untuk meningkatkan kepuasan pelanggan telah ditetapkan

• Fokus untuk meningkatkan kepuasan pelanggan selalu dipelihara/dijaga

Top manajemen harus

menjamin:


73

5.2 Kebijakan Mutu


74

5.3. PERANAN ORGANISASI, TANGGUNG JAWAB DAN WEWENANG


PlanningClause 6 - ISO 9001:2015

6


76

Clause 6: Planning for the QMS

Plan actions to address risks and opportunities

Determine risks and opportunities

4.1

9.2

6.1

6.1

Issues

6.1. Actions to address risks and opportunities6.2. Quality objectives and planning to achieve them6.3. Planning of changes


77

One can “slice and dice” these multiple dimensions of risk*

PortfolioConcentration

Risk

Transaction Risk

CounterpartyRisk

Issuer Risk

Trading Risk

Gap Risk

Equity Risk

Interest Rate Risk

Currency Risk

Commodity Risk

Risks

OperationalRisk

Reputational Risk

Business and strategic risks

Market Risk

Credit Risk

“SpecificRisk”

GeneralMarket Risk

Issue Risk


78

Threat map


79

Business Risk Assessment Process

Identify Risk

Assessment of Risk

Assessmentof Controls

BusinessManagement

Understand and analysethe business

Assess business

risk

Assess implementedrisk control

StrategyPlanning

ImplementationMonitoring

Improvement

Focus onstrategic

issues

Prioritisingof critical

risk

Improvedinternalcontrol

Managed Business


80

Risk context, assessment and treatmentRelevant

Issues (from

context)red = -vegreen =

+ve

Risk Identification Risk Analysis Risk

Evaluation Risk Treatment Residual risk

Neighbourhood

disruption in street

cabling

New fibre technology available

Workforce retention

Share holders:

Stock market crash

Economic – Significant

effect on profit objectives and

liquidity if share price collapses

Impact significant but likelihood unknown (high

uncertainty)

Unable to qualify as likelihood unknown

Subscribe to Economic indicators service for

horizon scanning economic conditions and

global trends

Unknown pending horizon

scan. Re-evaluate on

report receipt. Tolerate risk.

Transfer emergency funds

to holding company


81

SAMPLE - LIST OF RISK ITEMS

Design Engineering Risks Procurement Risks HSE Risks Project Management Risks Organizational Risks

Terms & Conditions

Contract RisksFEED Docs in ITB Docs are not detail and incomplete additional some procentage for Bill of Quantity calculation may required.

RFQ & RFP documents are not clear such as : Scope of Supply, Data Sheet, Bill of Quantity, Specification, Test Witness, Chemical /Oil/Grease Supply, Spare Part For Commissioning & 2 Years Operations, engineering document should be supply, Fabrication Schedule, Packaging Specification, General Condition, etc are not clear.

HSE Project Plan Implementation. High standard will impact to project cost and schedule

Project purpose and need is not well-defined

Inexperienced staff assigned

Refer To Legal Analysis on Draft of Contract from Legal Department or Refer to Analysis from Contract Engineer

Plot Plan, P&ID, One Line Diagram & Hazardous Area Change

Critical Items and Very tight Schedule that need special attentions

Risk Register and Risk Management Execution are not well done since Engineering Design Stage.

Project scope, schedule, objectives, cost, and deliverables are not clearly defined or understood

Losing critical staff at crucial time of the project

Inaccurate assumptions on technical issues in planning stage

Increase in material cost due to market forces

Environmental analysis (AMDAL) incomplete

Unreasonably high expectations from stakeholders

Insufficient time to plan

Surveys incomplete Political Situation is unstable, War, Riot, Embargo

Environmental regulation or local regulation is not Clear or Changed

Vendor or contractor delays Unanticipated project manager workload

Changes to Capacity, Materials or Specification

Economic is Unstable, Depression, Inflasion, Currency Rate is unstable, Oil Price is unstable or increase.

Construction Waste Treatment Availability

Estimating and/or scheduling errors

Internal “red tape” causes delay getting approvals, decisions

SIL, HAZID & HAZOP Study have potensial to add more materials, instrument & equipments.

Disaster, Climate, High/Low Tide and Other Nature Conditions.

Availability of project data and mapping at the beginning of the environmental study is insufficient

Unplanned work that must be accommodated

Functional units not available, overloaded

Basic Engineering Design Data & Detail Engineering Design Data are wrong.

Massive Development or Massive Construction in some country or Province that requires a lot of Cosntruction materials

New information after Environmental Document is completed may require re-evaluation or a new document (i.e. utility relocation beyond document coverage)

Lack of coordination/communication

Lack of specialized staff or Skilled MP resources are limited.

P&ID and Plot Plan Review Meeting are not so carefully done so it does not find a crucial problem

Loading & Unloading and Transportation Plan which need special attentions

New alternatives required to avoid, mitigate or minimize impact

Underestimated support resources or overly optimistic delivery schedule

Overlapping of one or more projects

Don't Consider Operability, Maintainability & Constructability

Import & Export Regulations are changed

Design changes require additional Environmental analysis

Inaccurate contract time estimates

Approval Procedure for Engineering Products is very long

Procurement Planning & Control are wrong

Unanticipated Noise, Air Quality and Waste impacts

Unresolved project conflicts not escalated in a timely manner

Project causes an unanticipated barrier to wildlife

Unanticipated escalation in right of way values or construction cost


82


83


84


85

The FMEA Form

Identify failure modes and their effects Identify causes of the

failure modesand controls

Prioritize Determine and assess actions

A Closer Look


86

Workshop 3


start

Risk Management


87

6.2. Quality objectives and planning to achieve them


88

Institusionalobjectives

progressingCurrent

Situation

Objective and Effort of the whole institution

Future Situation

Risk Analysis

Vision

Mission

Performance indicators

Risk AObjectives A

Risk BObjectives B

Risk CObjectives C


89

• Planning/implementing QMS changes (6.3), • Controlling operational changes, planned and

unintentional (8.1)• Addressing unplanned changes affecting products &

services (8.5.6) • See also 7.1.6 Organizational knowledge - for

addressing changing needs and trends, with respect to knowledge

6.3. ‘Planning of Changes’


ResourcesClause 7 - ISO 9001:2015

7


91

• 7.1 – Resources• Determine and provide the necessary resources

including people, infrastructure, operational processes, and knowledge

• 7.2 – Competence• Identify and maintain competence

• 7.3 – Awareness• Make objectives known, and ensure awareness of QMS

• 7.4 – Communication• What, when, how, who, and to whom

• 7.5 – Documented information• Reflects variety of sources and need to back up

information

Clause 7: Support


92

7.1. Sumber daya / Resources

7.1.2 Sumber Daya Manusia

7.1.3 Infrastruktur

7.1.4 Lingkungan Kerja

7.1.1. Organisasi harus menetapkan dan menyediakan sumber daya yang diperlukan

organisasi harus menyediakan orang-orang yang diperlukan untuk efektifitas operasi dari sistem manajemen mutu, termasuk proses yang diperlukan.

Organisasi harus menetapkan, menyediakan dan memelihara infrastruktur untuk operasi dari proses dalam mencapai kesesuaian produk dan jasa. Infrastruktur dapat mencakup: bangunan dan utilitas

terkait; peralatan termasuk

perangkat keras dan perangkat lunak;

transportasi; teknologi informasi dan

komunikasi.

Organisasi harus menetapkan, menyediakan dan memelihara lingkungan yang diperlukan untuk operasi dari proses untuk mencapai kesesuaian produk dan jasa.Lingkungan dapat mencakup fisik, sosial, psikologis, lingkungan dan faktor lainnya (seperti suhu, kelembaban, ergonomi dan kebersihan


93

These need to be determined/provided to ensure valid and reliable results. Controls will include: suitable resources, maintenance, documented information, measurement traceability (if required) including: verification, calibration status, adjustment safeguards, and appropriate corrective action on equipment malfunction.

7.1.5 Monitoring and measuring resources

Dimana pemantauan atau pengukuran yang digunakan untuk bukti kesesuaian produk dan jasa dengan persyaratan yang ditentukan, organisasi harus menentukan sumber daya yang dibutuhkan untuk memastikan kevalidan dan kehandalan dari hasil pemantauan dan pengukuran.

Organisasi harus memastikan bahwa sumber daya yang disediakan: cocok untuk jenis tertentu kegiatan pemantauan dan pengukuran yang

dilakukan; dipelihara untuk memastikan kesesuaian tujuan mereka.


94

• Defined as ‘available collection of information (meaningful data – facts about an object) being a justified belief and having a high certainty to be true’.

• This can include information such as intellectual property and lessons learned.

• The requirement here is to determine, maintain and make available (extent necessary) the knowledge necessary for the operation of its processes, AND to achieve conformity of products and services.

• Knowledge necessary to address changing needs and trends will also need considering, and how to acquire or access any additional knowledge necessary.

• Sources: (Internal) learning from failure/success, capturing knowledge of experts, etc. (External) academia, standards, conferences, customers, external providers etc.

7.1.6. Organisational Knowledge


95

Other supportKompetensi (7.2) Kepedulian (7.3) Komunikasi (7.4)

Organisasi harus: menentukan kompetensi yang

diperlukan untuk orang (s) yg. melakukan pekerjaan di bawah kendalinya dapat mempengaruhi kinerja mutu;

memastikan bahwa orang-orang ini kompeten atas dasar pendidikan, pelatihan, atau pengalaman;

di mana berlaku, mengambil tindakan untuk memperoleh kompetensi yang diperlukan, dan mengevaluasi efektivitas tindakan yang diambil;

menyimpan informasi terdokumentasi sebagai bukti kompetensi.

CATATAN tindakan Berlaku dapat meliputi, misalnya, penyediaan pelatihan, mentoring, atau re-assigment orang saat ini bekerja; atau mempekerjakan / mengontrak orang yang kompeten.

Orang yang melakukan pekerjaan di bawah kendali organisasi harus peduli terhadap: kebijakan mutu; sasaran mutu yang

relevan; kontribusi mereka

terhadap efektivitas SMM, termasuk manfaat dari peningkatan kinerja mutu;

implikasi ketidaksesuaian persyaratan sistem manajemen mutu

Organisasi harus menetapkan komunikasi internal dan eksternal yang relevan dengan sistem manajemen mutu termasuk: pada apa yang akan

dikomunikasikan; kapan berkomunikasi; dengan siapa

berkomunikasi; bagaimana berkomunikasi.


96

7.5. Documented Information


97

Pengendalian dokumenmenyetujui dokumen akan kecukupannya sebelum diterbitkan,

meninjau dan memperbaharui seperlunya dan menyetujui ulang dokumen,

memastikan perubahan dan status revisi terkini,

versi relevan dari dokumen yang berlaku tersedia di tempat pemakaian,

dapat dibaca dan mudah dikenali,

Pengendalian dokumen yang berasal dari luar

mencegah pemakaian tak disengaja dari dokumen obsolete (kadaluarsa)



9805/01/202398

Pengendalian RekamanIdentifikasi rekaman

Cara penyimpanan

Cara perlindungan

Cara pengambilan

Masa retensi

Cara pembuangan rekaman.Rekaman harus terbaca, dapat dikenali dan mudah

ditemukan.



99

Workshop 4


start

Documentation


OperationalClause 8 - ISO 9001:2015

8


101

Clause 8: OperationOperational planning and control

Requirements for products and services

Design and development of product‘s’ and services

Production and service provision, including

release

Control of externally provided products and services

Control of nonconforming process…


102

8.1. Operational planning and control

8.1 Perencanaan dan Pengendalian Operasional

Merencanakan, menerapkan dan mengendalikan proses yang diperlukan untuk realisasi produk.

Perencanaan realisasi produk harus taat azas dengan persyaratan

Menetapkan : Kriteria proses Kriteria keberterimaan produk dan

pelayanan kebutuhan sumber daya Pengendalian proses antara lain aktifitas

verifikasi, validasi, monitoring, measurement inspeksi dan test yang diperlukan spesifik teradap produk dan kriteria keberterimaan produk;

Informasi dokumen yang diperlukan termasuk rekaman diperlukan untuk menyediakan bukti bahwa proses-proses realisasi dan produk yang dihasilkan memenuhi persyaratan

Pengendalian perubahan Pengendalian “outsource”


103

8.2. Requirement for product and Services


104



105



106

8.3.5. KELUARAN DISAIN & PENGEMBANGAN

• Sesuai Masukan• Dapat diproses secara efektif

dan efesien

8.3.4. PENGENDALIAN DISAIN & PENGEMBANGAN

• Evaluasi kemampuan pemenuhan persyaratan

• VERIFIKASI (Self-checking, Pemeriksaan oleh personel/Team yang independent , Metode pembanding (Kalkulasi atau evaluasi design yang serupa), Test, simulasi atau uji coba

• VALIDASI, Memastikan sesuai dengan keinginan

• Identifikasi masalah dan tindak lanjut

8.3.3. MASUKAN DISAIN & PENGEMBANGAN

• Persyaratan Pelanggan & Pasar

• Peraturan• Disain sebelumnya• Sumber daya (material,

peralatan, Skill yang diminta, Evaluasi & pemeriksaan)

8.3.6. . PENGENDALIAN PERUBAHAN• Identifikasi• Pengendalian dokumen terkait• Informasi harus akurat & benar• Komunikasi yang efektif• Perubahan harus diverifikasi dan validasi

8.3.2. PERENCANAAN DISAIN &

PENGEMBANGAN• Tahapan proses

• tinjauan, verifikasi & validasi untuk setiap desain

• tanggung jawab & wewenang

• komunikasi dengan bagian terkait

8.3. Design & Development


107

8.4. Control of externally provided products and services


108



109



110

8.5.1. Pengendalian penyediaan produk dan pelayanan


111

Workshop 5


start

Process Identification


112

Organisasi harus:• identifikasi produk dengan cara sesuai diseluruh

realisasi produk , jika diperlukan• identifikasi status produk berkaitan dengan persyaratan

pengukuran dan pemantauan • mengendalikan dan merekam identifikasi khas dari

produk, bila mampu telusur dipersyaratkan

8.5.2. Identifikasi & Mampu Telusur


113

harus:• diidentifikasi• diverifikasi• dilindungi dan dijaga

milik pelanggan atau provider eksternal yang hilang, rusak atau karena suatu hal tak layak pakai harus direkam dan dilaporkan

Property mencakup “intelektual property”

8.5.3. property belonging to Customers or External providers


114

Preservasi kesesuaian produk selama proses internal dan penyerahan

Mencakup: identifikasi penanganan pengemasan penyimpanan perlindungan bagian-bagian yang menjadikan produk

8.5.4. Preservasi


115

8.5.5. Post Delivery Activities


116

8.5.6. Control of Changes


117

8.6. Release of Product and Services


118

8.7. Control of NonConforming Output


Performance EvaluationClause 9 - ISO 9001:2015

9


120

Clause 9 – Performance evaluation

• 9.1 – Monitoring, measurement, analysis and evaluation• What needs to be monitored and measured, how and when

• 9.2 – Internal audit • To establish whether the QMS conforms to requirements

and is effectively implemented and maintained• 9.3 – Management review

• Top management must regularly review the QMS


121

Clause 9 – Performance evaluation9.1. Monitoring,

measurement, analysis and evaluation

9.1.1

9.1.2

9.1.3

(General)

(Customersatisfaction)

(Analysis andevaluation)

• What needs to be monitored and measured, how and when


122

9.1.2. Customer Satisfaction

Faktor loyalitas pelanggan

BASIC

EXPECTED

DESIRED

UNANTICIPATED

Faktor Kepuasan

Standar minimun yg diterima

Nilai rata-rata (sama seperti jasa lainnya)

Apa yang diinginkan pelanggan

Melebihi apa yang

diinginkan pelanggan


123

Clause 9 – Performance evaluation

9.2. Internal AuditTo establish whether the QMS conforms to requirements and is effectively implemented and maintained

At planned intervals

(status and importance)

Ensure system

conforms to planned

arrangements

Ensuresystem

conforms to ISO 9001

Effectively implement

ed and maintained

Follow-up actions

Audit criteria, scope, frequency, methods defined in documented information


124

9.3. Management Review

Sistem harus ditinjau oleh top managemen :

• dalam interval yang direncanakan• untuk menjamin berlanjutnya kesesuaian, kecukupan dan

keefektivan• untuk menilai kesempatan untuk peningkatan dan• kebutuhan untuk perubahan sistem, kebijakan dan sasaran

mutu


125

Management Review

Previous actions/status

External/internal issues

N/C’s, corrective actions

Monitoring/Measurement

Audit results

Customer satisfaction

External providers

Adequacy ofresources

CONSIDER:

REVIEW

Process performance

Risks andopportunities

Continual improvement (C.I)

Opportunities (C.I)

Changes to QMS

Resource needs

Doc. Information

WHAT NEEDSTO CHANGE?

! !


ImprovementClause 10- ISO 9001:2015

10


127

Clause 10: Improvement

Improvement

Nonconformity and corrective action

Continual improvement


128

Improvement


129

What to evaluate ?

Action

•Policy•Critical Success

Factor•Measurement

•Program

•Data collected•Responsibility

•Frequency•Method

•Corrective•Correction• Improvement

How to evaluate ?

Analyze


130

Nonconformity and corrective action


131

QUALITY PROBLEM•Operational Cost•Customer satisfaction Result •Non conformity•Performance•Health & Safety

CORRECTIVE ACTION •Coordination between function•Caused identification•Analysis & corrective action plan•Follow up•Implementation monitoring, efficiency and evaluation on its effectiveness

POTENTIAL

PROBLEMS

CONTINUAL IMPROVEMENT

PREVENTIVE ACTIONS•Caused identification•Analysis & preventive action plan •Implementation•Implementation monitoring, efficiency and evaluation on its effectiveness (Management Review)



132



133

Review and Final Questions

?