Nci Presentation 14

•PERA International
•Who is NCI ?
•Introduction to NCI Product
•Neville Clarke System
Development Methods
•What Our Client Say

•Our Services
•Our Client
•Our Consultant
•Cost & Budget

• Main Menu
If you need more information about our product,
please contact us
Introduction to Pera International
Pera Integrated Training Pera Technology Pera Asia Pacific

• Middle Aston House, • Innovation Park • Pera Neville Clarke
Oxfordshire • Leicestershire • 9 offices
• Training &Consultancy • Technology • Management
Innovation
• Performance Academy Systems
• Pera Knowledge
Centre • Operational
improvement
• Business
Connection
<< Home >>

1988 • Established in UK
• Business expansion to Asia Pacific

1990 • Start up offices opened in both Singapore and Kuala Lumpur
1992 • Opened office in Bangkok, Thailand
• Business expansion in Malaysia; another office in Penang

1993 • Opened first office in Philippines, Manila
1995 • Opened first office in China, Beijing
1996 • Acquired by PERA Consulting
1997 • Another office in Malaysia, Johor Bahru
1998 • Opened first office in Indonesia, Jakarta
2004 • Fruitful year with 2 new business offices; Shanghai and Kuching
• Corporate branding as Pera Neville Clarke

2005 • Business expansion to Tianjin and Cebu
2007 • NCI manage by local management
• One of the largest international consulting firm in Asia Pacific

2010 • Corporate rebranding as Neville-Clarke International
Milestones…
Neville Clarke Solution for Success
Explore
Understand the
Improvement
Identify and prioritise the
Engage externally to the Engagement opportunities Evaluation opportunities for
extended value chain improvements.
Expand internally to Acquire the knowledge and

support processes
Expansion Education align the initiative with
business strategy
Execution
Execute the projects to realize the benefits.

How We Can Support…
Explore Evaluation Education Execution Expansion Engagemen

t
Management Organisational Performance

System Excellence Management
Business Solutions
Neville Clarke International
United Singapore Malaysia China Indonesia Philippines

Kingdom • Singapore • Kuala Lumpur • Beijing • Jakarta • Manila
• Oxfordshire • Penang • Tianjin
• Johor Bahru • Shanghai
• Kuching
Representative
offices
Korea Thailand
•Seoul • Bangkok
Neville-Clarke Indonesia: Our
Clients
China
UK
Switzerland
Malaysia
US
Egypt
Philippines
Singapore
Kenya
Srilanka
Indonesia
Introduction to NCI Product
ISO 9001 ISO 14000 OHSAS 18000
Management System ISO/TS 16949
HACCP & ISO 22000
ISO 20000/27000
ISO 28000
NCI
Product Testing& Lab
Others
Six Sigma
Operational Excellence Lean
Lean Sigma
People Development
Others
Strategic Management
<< Home >>
Others
Introduction to ISO 9001:2008
<< Home Introduction to NCI Product >>

What is ISO 9001:2008?
• An internationally recognised series of

Quality Management System standards
• Adopted by many countries as National
Standards
• Used as a framework/tools for develop
organization Document Quality
Management System (DQMS)

ISO 9000:2008 Series
• ISO 9000 Quality Management

Systems:
Fundamentals and Vocabulary
Systems:
Requirements
Systems:
Guidance for Performance
Improvements
• ISO 19011 Guidelines on Quality and
Environmental Auditing
ISO 9001:2008 Requirements
1 Scope 7 Product realisation

2 Normative reference 7.1 Planning of product realization
3 Terms and definitions 7.2 Customer related
4 Quality management system processes
5 Management responsibility 7.3 Design and development
7.4
5.1 Management Commitment
Purchasing
5.2 Customer focus 7.5 Production and service provision
5.3 Quality Policy 7.6 Control of monitoring and
5.4Planning measuring
5.5 Responsibility, authority and devices
communication
8Measurement, analysis and
5.6 Management review
improvement
6 Resource 8.1
management General
6.1 Provision of 8.2 Monitoring and measurement
resources 8.3 Control of nonconforming
6.2 Human resources product
6.3 Infrastructure 8 8.4 Analysis of data
6.4 Work environment 8.5 Improvement

ISO 9001:2008 QMS Model
CONTINUAL IMPROVEMENT OF
THE QUALITY MANAGEMENT SYSTEM
Management
responsibility
Customers
Measurement,
Resource Analysis and Satisfaction
Customers management improvement
Input Output
Product
Requirements Product
realization
Model of the process-based quality management system

Why ISO 9001:2008 using Process Model?
• Focus to Customer
• Cover the whole process to operate business
• Horizontal approach is necessity
• Integrating all activities to produce an output
• Establishing interfaces among processes & procedures
• Establishing coordination & communication
• Concern to internal customer & supplier
• Quality system shall reflect the real activity in the field

Key Benefits of ISO 9001:2008
• Standardization and Simplification

• Improve Business Process Performance
• Improve Quality System Effectiveness
• Foundation for Continuous Improvement
• Increase Customer Satisfaction
• Increase Efficiency
• Increase Profitability

Introduction to ISO 14000

What is ISO 14000?
• Internationally-recognized Environmental
Management System series of Standards
• Consist of – ISO 14001
– ISO 14004
• Only ISO 14001 will be used as basis of
certification

ISO 14001 Requirements
1. Scope 4.4 Implementation and operation

4.4.1 Resources, Roles, responsibility
2. Normative reference and authority
4.4.2 Competence, Training and
3. Terms & Definitions
Awareness
4. Environmental management system 4.4.3 Communication
requirements 4.4.4 Documentation
4.4.5 Control of Documents
4.1 General requirements 4.4.6 Operational control
4.2 Environmental policy 4.4.7 Emergency preparedness and
4.3 Planning response
4.3.1 Environmental Aspects 4.5 Checking and corrective action
4.3.2 Legal and other requirements 4.5.1 Monitoring and measurement
4.3.3 Objectives, targets & 4.5.2 Evaluation of Compliance
programmes 13 4.5.3 Nonconformity, Corrective
action and Preventive action
4.5.4 Control of Records
4.5.4 Internal audit

ISO 14001:2004 EMS Model
Continual Improvement
Planning
Management Review •Environmental aspects
•Legal and other requirements
•Objectives and targets and programmes
Implementation and Operation

Checking and Corrective Action •Resources, Roles, Responsibility & Authority
•Monitoring and measurement •Competence, Training and Awareness
•Evaluation of compliance •Communication
• Documentation
•Non Conformity, Corrective action
and Preventive Action •Control of Documents
• Control of Records •Operational control
•Internal Audit •Emergency preparedness and response

Why Implement ISO 14001?
• Enhance company’s image

• Compliance with legal regulations
• Uphold public responsibility
• Basis for continual improvement
• Avoid trade barriers
• Reduce cost

Introduction to OHSAS 18000

What is OHSAS 18000?
• Internationally-recognized Occupational Health &

Safety Management System series of Standards
• Consist of – OHSAS 18001
– OHSAS 18002
• Only OHSAS 18001 will be used as basis of
certification

OHSAS 18001 Requirements
1. Scope 4.4 Implementation and operation

4.4.1 Structure and responsibility
2. Reference publications
4.4.2 Training, awareness and
3. Terms and definitions competence
4.4.3 Consultation & communication
4. OH&S management system elements
4.4.4 Documentation
4.1 General requirements 4.4.5 Document and data control
4.2 OH&S policy 4.4.6 Operational control
4.3 Planning 4.4.7 Emergency preparedness and
4.3.1 Planning for hazard response
identification, risk 4.5 Checking and corrective action
assessment and risk control 4.5.1 Performance measurement and
4.3.2 Legal and other requirements monitoring
4.3.3 Objectives 4.5.2 Accidents, incidents,
4.3.4 OH&S management non-conformances and
programme(s) corrective and preventive
action
4.5.3 Records and records
management
4.5.4 Audit

OHSAS 18001:1999 OHSMS Model
Continual Improvement OH&S Policy
Management Review Planning

•Planning for hazard identification,
risk assessment and risk control
•Legal and other requirements
•Objectives
•OH&S management programmes
Implementation and Operation
Checking and Corrective Action •Structure & responsibility
•Performance measurement and •Training, awareness and competence
monitoring •Consultation & Communication
•Accidents, incidents, non-conformances •Documentation
and corrective •Document and Data Control
and preventive action •Operational control
•Records and records management •Emergency preparedness and response
•Audit

Why Implement OHSAS 18001?
• Reduce legal liability

• Save costs e.g. lower medical costs
• Avoid losses from production down time
owing to injuries
• Improve productivity and staff morale
• Create hazard-free working environment
for employees

Introduction to ISO/TS 16949:2009

ISO/TS 16949 : 2008
• Aims to be an International Automotive Standard

• Coupled with customer-specific requirements defines quality
system requirements for use in the automotive supply chain
• Requires independent third party registration for
assessment and certification
• First Edition, 1999; Second Edition, 2002, third edition 2008

ISO/TS 16949 : 2009
• Harmonization of customer requirements for International

Automotive Task Force(IATF) and Japan Automobile
Manufacturer Association (JAMA) member company
• Prepared by IATF, JAMA and ISO/TC 176
• Established based on ISO 9001:2000 and ISO 9004:2000,
AVSQ (Italy), EAQF (France), QS-9000 (U.S.) and VDA6.1
(Germany) automotive catalogs
• Majority of global automobile manufacturers are involved.

ISO/TS 16949 : 2009QMS Model
CONTINUAL IMPROVEMENT OF
THE QUALITY MANAGEMENT SYSTEM
Management
responsibility
Customers
Measurement,
Resource Analysis and Satisfaction
Customers management improvement
Input Output
Product
Requirements Product
realization
Model of the process-based quality management system

Key Benefits of ISO/TS 16949:2009
• Standardization and Simplification

• Improve Business Process Performance
• Improve Quality System Effectiveness
• Foundation for Continuous Improvement
• Increase Customer Satisfaction
• Increase Efficiency
• Increase Profitability

ISO TS 16949 Core Tools
• APQP PPAP Control Plan

• FMEA
• SPC
• MSA
• Customer specific requirement

ISO TS 16949 APQP – PPAP
• Timing Plan
1. Planning
2. Product Design & Development
3. Process Design & Development
4. Product & Process Validation
5. Production
Plan & Product Design Process Design Product & Feedback

Define & Development & Development Process Assessment &
Program Verification Verification Validation Corrective
action

ISO TS 16949 FMEA
Design or
Process
Function
Potential
Failure
Mode Potential
Effect of
Failure Potential
Cause
Current
Determine Design
SEVERITY Controls
Determine
OCCURRENCE
Determine
PREVENTION/DETECTION

ISO TS 16949 SPC
• Variable
• Xbar R
• Xbar S
• X MR
• Atrribute
• P chart
• NP chart
• C chart
• U chart

Variable Control Chart
Control Chart x – R (Minitab)
Pera Neville-Clarke, 2009

Slide No 35 AMS105 (BI) Issue 6, Jan 2009
Process Capability Analysis
Metode untuk meng-estimasi

variability within subgroup
manakala subgroup size
lebih dari 1. Defaultnya
adalah pooled standard
deviation

Process Capability Analysis
Didapat dari
within
subgroup
variability
Didapat
dari
standard
deviation
dari the
data

ISO TS 16949 MSA
• Variable
• Short Method Xbar –R
• Long Method Xbar – R
• Anova Method
• Attribute
• Apraisal Agreement
• Gauge Performance Curve

Repeatability
Repeatability
Good Repeatability Bad Repeatability

Reproducibility
Reproducibility
Operator A B C
A B C A B C
Good Reproducibility Bad Reproducibility

Gage R&R
• Estimate the combined variation of

repeatability and reproducibility.
σ 2
GRR σ 2
reproducibility σ 2
repeatability

Neville Clarke’s ISO TS
Development
• 4 Development phases
• Focus on Business process development and
APQP Timing Plan
• Support for documentation management
system and its implementation
• Align with IATF rule for ISO TS 16949 recognition
• 2 stages certification process

Introduction to HACCP and ISO 22000:2005
Food Safety Management System

Introduction to HACCP
HACCP is
Hazard Analysis Critical Control Points
HACCP is an internationally accepted techniques

for preventing microbiological, chemical and
physical contamination along the FOOD SUPPLY
CHAIN

Overview of HACCP Principles
Suppliers
1. Identify hazards & preventive measures

2. Identify Critical Control Points
3. Establish Critical Limits
4. Establish a CCP monitoring system
5. Establish corrective action procedures
6. Establish verification procedures
Finished
7. Establish documentation and records
Goods Delivery

Food Poisoning Cases
• In 1987, amount of food poisoning in USA was about USD

6,300,000
• In the period of 1991 – 1994, there were 2,661 cases in

Holland
• Yearly approx. 2 million gastroenterological infections

reported
• Tragedy : Snow Brand in Japan, Dioxin in Europe, Biscuit &

Milk in Indonesia, etc.

Consequences for the Company
• Product Recall
• Corrective & Preventive Action (for RM, PM, HR,
Equipment, Procedures, etc.)
• Lost of time, energy & money

Major Causes of Food Incidents
• Supply of poor quality RM

• Mishandling of RM
• Change in formulation of product
• Change in the process of product
• Cross Contamination
• Inadequate cleaning
• Inadequate maintenance
• Addition of wrong ingredient, etc

Why HACCP Needed
• Legislation and regulatory authorities require it
• Consumers has become more critical : ready to eat, quickly

to prepare, as fresh as possible, have a long shelf life, not
contain too many preservatives.
• Consumers are demanding products with high degree of

safety, consistency & value for money.

Why HACCP Needed
• It provides manufacturers with :

- Self-confidence
- Assurance
- Brand protection
• It is verifiable and auditable
• It provides sound evidence (assurance) which can be used

in litigation

What is ISO 22000:2005
• ISO 22000:2005 is an international certification standard

that defines the requirements of food safety management
system.
• It can be used by all organization, in the supply chain –

from farmer to food services, to processing, transportation,
storage, retail and packaging.

Interactive Communication in Food Chain
Producers of pesticides, fertilizers

Statutory & regulatory authorities
Crop & Feed producers

Producers of ingredient & additives
Primary Food producers Transport & storage operators
Producers of equipments
Food Manufacturer
Prod of cleaning & sanitizing agents
Secondary Food Manufacturer Prod of packaging materials
Service providers
Wholesalers
Retailers, food service & Caterers
CONSUMERS

Comparisons
ISO 22000 ISO 9000 HACCP
Food Safety Mgt System Quality Mgt Principle 7

System Doc & Record
Mgt Responsibility Mgt Responsibility Mgt Responsibility

5.7. Emergency Preparedness &
Response
Mgt of Resources Mgt of Resources Establish HACCP Team
Planning & Realization of safe Product Realization Principles 1-3

products Hazards, CCP, critical limit
Validation, verification & Measurement, analysis & Principle 4-6

improvement improvement Monitoring, CA &Verification

Comparisons
ISO 22000
HACCP
- GMP
- PRP
Food Safety Management System

Benefits of ISO 22000:2005 Certification
• A Single Standard – for approx. 148 countries

worldwide for all food chain
• It’s a Business – building tool to improve the

business performance

Another Benefits
• Clear communication across the entire supply chain

• Traceability on food safety
• Control / reduction of food safety hazards
• Legal compliance
• Cost effectiveness
• Brand Protection
• Continuous improved business performance in line with the
food safety policy and objectives.

The Structure of HACCP
5.11. Verification
5.2 5.6.1. Specific Control Measure

5.1. Products Related to CCP’s
Mgt 5.7 5.8 5.10
5.5 5.9
Respon- 5.3 Critical Moni-
CA
Vali
Processes Hazard Limit toring
sibility Analysis
Da
tion
5.4 5.6.2. General Control Measure
PRP
5.12. Documentation

Planning of Safe Foods
7.3.2. Food safety team
7.3.3. Product Characteristic

7.3.4. Intended use
7.3.5.1. Flow Diagrams
7.3.5.2. Desc. of process step & control measure
4.2 & 7.7 7.2

7.4.2. Hazard ident & determ. of accept level
•Docu PRP
mentation 7.4.3. Hazard assessment
7.4.4. Selection & ass. of control measures

7.6. Establish
7.5. Establish opr. PRP HACCP Plan
8.2. Validation of Control measure
7.8. Verification Planning

What is GMP?
Good Manufacturing Practices (GMPs) are

minimum common sense sanitary and
processing requirements which should apply to
all food processing establishment. GMP
generally relates to good house keeping
practices concerning food safety and quality

What is GMP?
GMP, according to FDA regulations, are

divided into four areas:
General Provision
Building and Facilities
Equipment
Production & Process Control

What is GMP?
While GMP compliance can be used as a

starting point for controlling food safety
risks, it is deficient in several aspects. Most
importantly, GMPs are designed to cover all
types of processing operations, and thus are
too broad to address many plant-specific or
product-specific hazards.

GMP Requirement
4.1 Definitions
4.2 Personnel
4.3 Plant and Grounds
4.4 Sanitary Operations
4.5 Sanitary Facilities and Controls
4.6 Equipment and Utensils
4.7 Process and Controls
4.8 Warehousing and Distribution
4.1 Definition (21 CFR 110.3)
Definition of term which used on the GMP

Personnel 21 CFR 110.10
The plant management shall take all
reasonable measures and precautions to
ensure the following:
a) Disease control
b) Cleanliness
c) Education and training
d) Supervision
Pera Neville-Clarke International, 2005

Slide No 64 GMP Issue 1
Jul 2005 Rev 0 Jul 2005 << Home Introduction to NCI Product >>
Grounds
21 CFR 110.20
Ground shall be kept in a condition that
will protect against the contamination
of food.
The methods include:

• Properly storing equipment, removing litter and waste, and
cutting weeds or grass
• Maintaining roads, yards, and parking lots
• Adequately draining areas
• Operating systems for waste treatment and disposal

Sanitary Operations
21 CFR 110.35
a) General maintenance
 Buildings, fixtures shall be
maintained in a sanitary
condition and shall be kept
in repair sufficient to
prevent food from becoming
adulterated.

Sanitary Operations
21 CFR 110.35
a)General maintenance
Cleaning and sanitizing
of utensils and equipment
shall be conducted in a
manner that protect
against contamination.

Sanitary Facilities and Controls
21 CFR 110.37
Each plant shall be equipped with adequate
sanitary facilities and accommodations including:
a) Water supply
b) Plumbing
c) Sewage disposal
d) Toilet facilities
e) Hand-washing facilities
f) Rubbish and offal disposal

Equipment and Utensils
21 CFR 110.40
a) All plant equipment and utensils,
shall be so designed and of such material and
workmanship as to be adequately cleanable,
and shall be properly maintained.
 shall preclude the adulteration of food
 should be so installed and maintained as to
facilitate the cleaning of the equipment and of
all adjacent spaces
 food-contact surfaces shall be corrosion-
resistant
 shall be made of nontoxic materials
 shall be maintained to protect food from
being contaminated by any source, including
unlawful indirect food additives.

Jul 2005 Rev 0 Jul 2005
Processes and Controls
21 CFR 110.80
 All operation shall be
conducted in
accordance with
adequate sanitation
principles.
 Raw Material
 Manufacturing

Jul 2005 Rev 0 Jul 2005
Warehousing and Distribution
21 CFR 110.110
Storage and transportation of finished
food
 shall be under conditions that will
protect food against contamination as
well as deterioration of the food and
the container.

Jul 2005 Rev 0 Jul 2005
GMP certification in Indonesia
• Commonly use BPPOM for GMP
certification in Indonesia
• Some register such as SGS is also offers
this certification.
ISO 13485 Medical devices —
Quality management systems —
Requirements for regulatory purposes
ISO 13485
This International Standard specifies requirements for a quality management system where an
organization needs to demonstrate its ability to provide medical devices and related services that
consistently meet customer requirements and regulatory requirements applicable to medical
devices and related services
Main Feature of ISO 13485
• Quality Management System Requirement
• With guide on implementation on ISO 14949
• Risk Management Requirement
• With guide on implementation on ISO 14971
• Exclusion to Product Design and Development
is only allow by regulatory
• “Non-inclusion”of product realization
requirements is allowed if those functions are
not required by the nature of the medical device
being provided by the organization.
Feature of ISO 13485 (1)
• Management Responsibility
• Management Commitment
• Customer Focus
• Quality policy
• Quality objectives
• setting quality objectives & associated targets for the
quality management system AND for medical devices &
related services (see 7.1 a)
• Responsibility and Authority
• Management Review
• Regulatory Requirement
•
Feature of ISO 13485
Product and Service Provision Important Point
(3)
• Risk Management – along “Product Realization” life cycle. ISO 14971
as guidance
• Product Design Feature include
• Intended use of the device,
• Indications and contra indications for use of the device
• performance claims and performance requirements (including normal use, storage, handling and maintenance),
• User and patient requirements,
• Physical characteristics,
• Human factors/usability requirements,
• Safety and reliability requirements,
• Toxicity and biocompatibility requirements
• Control of Product and Service Provision

• Cleaness
• Installation
• Servicing
• Identification and Tracebility

• Product Preservation
• Callibration
Feature of ISO 13485 (4)
• Measurement Analysis and Improvement
• Feedback rather than customer satisfaction measurement
• Control of Non Conforming Product
• Claim handling and need on corrective action
ISO 13485 Implementation Strategy
Management System Requirements
Customer
Work Instructions
process 1 context Diagram procedure Policy & Forms
process 5 procedure Work Instructions

process 2 context Diagram Policy & Forms
process 6 process 3 procedure Work Instructions

context Diagram Policy & Forms

context Diagram Policy
Customer & Forms
Business
Process Procedure Company Support
Manual Manual
Documentation Manual
Risk Assesment and Management

<< Home | Neville Clarke System Development Methods >>
Neville Clarke’s Business Process Approach
VENDOR
SUB-CON
PURCHASING
DELIVERY WARE
DELIVERY
PRODUCTION HOUSE CUST.
MATERIAL
PLANNING
QUALITY
CUST. MARKETING PRODUCTION MAINTENANCE
REQ.
PLAN
COST ESTIMATE
PRODUCTION
PROJECT ENGINEERING
ENGINEERING
TOOLS MAKING
CTRL OF
DEFECTIVE
CUSTOMER
C.A. & CTRL OF BUSINESS MANAGEMENT
FINANCE SATIS- IQA HRD
P.ACTION DOC’s PLANNING REVIEW
FACTION

VENDOR
SUB-CON PURCHASING
7.4
DELIVERY WAREHOUSE DELIVERY

PRODUCTION 7.5, 8.2.4 7.5, 8.2.4 CUST.
MATERIAL
PLANNING
MARKETING QUALITY PRODUCTION MAINTENANCE

CUST.
REQ. 7.2 PLAN 7.1 7.5, 8.2.4 6.3
COST ESTIMATE PRODUCTION

PROJECT ENGINEERING
ENGINEERING 7.1 7.3
TOOLS MAKING
CTRL OF
DEFECTIVE
8.3
CTRL OF CUSTOMER
C.A. & BUSINESS MANAGEMENT
DOC’s SATIS- AUDIT HRD
P.ACTION FINANCE PLANNING REVIEW
4.2.3, FACTION 8.2.2 6.2
8.4, 8.5 5.4 5.6
4.2.4 8.2.1

Key on Implementation
• Management comittment on Resources
and Implementation
• Team work on Risk Management and
Documentation Development
• Support on Implementation and Audit
Accellent Manufacturing Sdn Bhd
Advance Pact Sdn Bhd
Alliance Contract Manufacturing Sdn Bhd
Ansell Services (Asia) Sdn Bhd
Ansell Shah Alam Sdn Bhd
Our Client on 13485
Avaplas Sdn Bhd
Benchmark Electronics (M) Sdn Bhd AB Sciex Pte Ltd
Celestica Electronics (M) Sdn Bhd Affymetrix Pte Ltd
Diptech Industries Sdn Bhd Applied Biosystems B.V.
Escatec Electronics Sdn Bhd BD Critical Care Systems Pte Ltd
Escatec Mechantronic Sdn Bhd Becton Dickinson Medical (S) Pte Ltd
Faber Medi-Serve Sdn Bhd Becton Dickson Medical Products Pte Ltd
Flextronics Technology (Malaysia) Sdn Bhd Benchmark Electronics Singapore IPO Pte Ltd
Green Point Precision (M) Sdn Bhd CIBA Vision Asian Manufacturing and Logistics Pte Ltd
DX Assays Pte Ltd
Healthtronics (M) Sdn Bhd Hi-P International Ltd
HOE Pharmaceuticals Sdn Bhd Illumina Singapore Pte Ltd
Manufacturing Integration Technology Limited
Integrated Supply Chain Sdn Bhd PCI Ltd
Kinsmedic Sdn Bhd PT Sanmina-SCI Batam
Lemtronics Sdn Bhd Sanmina-SCI Systems Singapore Ptd Ltd
Leonix Sdn Bhd Volume Interactions Pte Ltd
Medical Rubber Products Sdn Bhd John While Solutions (S) Pte Ltd
Meiban Technologies (Malaysia) Sdn Bhd Minntech Asia/Pacific Pte Ltd
PCA Tech (M) Sdn Bhd Agilent
Pentamaster Equipment Manufacturing Sdn Bhd Zuelling Pharma Specialty Solutions Group Pte Ltd
PNE Electric Sdn Bhd Intricon Pte Ltd
Professional Tools & Dies Sdn Bhd JMS Singapore Pte Ltd
Sanchem Corporation Sdn Bhd
Sanmina-SCI Systems (Malaysia) Sdn Bhd
Sanwa BioPlastic Pte Ltd
Sanwa Plastic Industry Sdn Bhd
SCM Technologies Sdn Bhd
Senzpak (M) Sdn Bhd
SMT Technologies Sdn Bhd & EG Wireless Sdn Bhd
Technocom Systems Sdn Bhd
UWC Healthcare Manufacturing Sdn Bhd
Venture Electronics Services (M) Sdn Bhd
Winchester Electronics (M) Sdn Bhd
Zoomic Technology (M) Sdn Bhd
Introduction to ISO 17025

What is ISO 17025?
• Specific requirement to be met by

laboratories wishing to achieve the
production of competent result
• Keywords:
Accurate and Trusted

The Principles
• Capacity
• Exercise of Responsibility
• Scientific Method
• Objective of Result
• Impartiality of Conduct
• Traceability of Measurement
• Repeatability of Test
• Transparency of Process

Why is ISO 17025 needed ?
• Regulatory requirement
• Customers requirements
• Consumers expectation
• ISO 17025 system is verifiable & auditable
• Good Management of Laboratory (GLP)

Benefits of ISO 17025
• Increase confidence in Laboratory Testing
• Effective and efficient deployment of

resources
• Cost effective control system
• Improve teamwork

Requirements of ISO 17025
1 Ruang Lingkup 4.10 Tindakan perbaikan

4.11 Tindakan pencegahan
2 Acuan Normatif 4.12 Pengendalian rekaman
4.13 Audit
3 Istilah dan Definisi
Internal
• Persyaratan Manajemen 4.14 Kaji ulang manajemen
4.1 Organisasi
4.2 Sistem mutu • Persyaratan Teknis
5.1 Umum
4.3 Pengendalian dokumen
5.2 Personal
4.4 Kaji ulang permintaan, tender dan
5.3 Kondisi akomodasi dan
kontrak lingkungan
4.5 Subkontrak pengujian dan
• 5.4 Metode pengujian, kalibrasi & validasi
kalibrasi 5.5 Peralatan
4.6 Pembelian jasa dan perbekalan 5.6 Ketertelusuran pengukuran
4.7 Pelayanan kepada pelanggan 5.7 Pengambilan sampel
4.8 Pengaduan 5.8 Penanganan barang diuji & dikalibrasi
5.9 Jaminan mutu pengujian & Kalibrasi
4.9 Pengendalian pekerjaan pengujian
5.10 Pelaporan hasil
dan/atau kalibrasi yang tidak sesuai

Key Point on ISO 17025
Implementation (1)
• Policy
• Lab Scope
• Define certification scope and
testing capabiltiy
• Documented Procedure
• Doc Control
• Record Control
• Contract Review
• Supplier Management – Service and Product
• Complain
• IQA
• Management Review
• Corrective preventive action

Key point on ISO 17025
Implementation (2)
• Environment Condition
• People Competence
• Test Method
• Traceable to International Standard
• Agreed by client
• Uncertainty Measurement
• Control of data processing
• Equipment Maintenance
• Calibration process

Key point on ISO 17025
Implementation (3)
• Measurement Tracebility
• Traceable to international standard
• Data Processing
• Sampling Methodology
• Test Report
• Opinion on test report

Benefits of partnership with
Neville Clarke on ISO 17025
• Focus not only management system
• Guide on development uncertainty

•
• Better Project Management and effective
control
• Experienced consultant

Comparison of ISO
17025 and ISO 17020
17025 17020
•Not stated level of •Type A, B and C
independence
•Provide result •Provide judgement
•Testing and callibration •Testing only

What is ISO 17020
• Specific requirement to be met by

Testing Bodies wishing to achieve the
production of competent result
• Keywords:
Independence, Impartiality, Integrity

3 Type of Testing Bodies
• A Type : 3rd Party Testing bodies

• Not involve in Design, Manufacturing or maintenance of
equipment to be tested
• B Type : In House testing bodies

• Separate organization. I.e from Design, Production
• C Type : In House Testing Bodies
• Involve in the organization,
• I.e Involve in the design process, production

Starting Point
• Legal Entitiy
• Laboratory Scope
• Liability Insurances
• Independence finnance audit

Requirements of ISO 17020
1 Scope 11 Handling Inspection samples

2 Definition Items
3 Administrative Requirement 12 Record
4 Independence, Impartiallity , 13 Inspection Record and
Integrity Inspection certificate
5 Confidentiallity 14 Subcontracting
6 Organization and Management 15 Complain and appeals
7 Quality System 16 Cooperation
8 Personnel
9 Facility and Equipment
10 Inspection method and
procedures

Why we need ISO 17020
• Regulatory requirement
• Customers requirements
• Consumers expectation
• ISO 17020 system is verifiable & auditable
• Good Management of Testing Bodies

Benefit ISO 17020
• Increase confidence in Laboratory Testing
• Effective and efficient deployment of

resources
• Cost effective control system
• Improve teamwork

Introduction to Six Sigma

Six Sigma: Special Features
 Effective leadership involvement

 Rigorous approach to managing and improving
business processes
 Disciplined use of facts and data
 Results oriented
So, What is Six Sigma?
Six Sigma is a Management Tool
A Comprehensive System Encompassing a Broad Array of
Best Practices and the Latest Know-how for Improving Profit

Reducing CPQP
High Hanging Fruits
Bulks Of Fruits Six Sigma Approach
Low Hanging Fruits

QCC & 7 Basic Tools
Common Sense &

Ground Fruits Intuition

Six Sigma Approach – Overall Framework
Enabling
Mindset Operation Customer Skill
Efficiency Satisfaction
Define
Champions Critical-To-Quality
Data
+
Dashboard Measure
Analysis
Tools
Process Improvement
Black Belts (projects) M-A-I-C
& Green Belts
Profit Project Savings

Methodology : DMAIC Approach
Phases Key Activities Responsibility
• Identify Performance Drivers
DEFINE • Create Projects Champion
• Verify Measurement System
MEASURE • Understand Current Performance
• Brainstorm Possible Causes
Green Belt
ANALYSE • Validate Root Causes
Black Belt
• Identify Improvement Solutions
IMPROVE • Verify Effectiveness
• Establish Control System

CONTROL • Disseminate Lessons Learned

Methodology - Identifying Projects
Sub-CTQ 1 Project 1
CTQ 1
Sub-CTQ 2 Project 2
Objective A
Business Sub-CTQ 3 Project 3
Plan CTQ 2
Sub-CTQ 4 Project 4
Objective B
Role &
Responsibility
Executive Team Champion
Black Belts
Green Belts

Six Sigma Implementation Infrastructures
Roles &
Responsibilities Training Program
Senior Executives Senior Executives

Six Sigma Committee
Champion
Champion, MBB, BB, GB
Project Teams BB / GB
Finance Representative Awareness

Six Sigma
Projects Selection Personnel Selection
Benefits
Implementation
Projects Review Incentive System Schedule
Project Tracking Project Selection Criteria Training

Schedule
Dashboard Project Savings Calculation
Processes Policies Deployment Plan

Typical GE Six Sigma Organization Structure
Managing Director
Six Sigma Dept. Master

Finance Rep. Black Belt
Division Division Division Division

Manager Manager Manager Manager
(Champion) (Champion) (Champion) (Champion)
Black Belt - Full Time Black Belt - Full Time
Engineer Engineer Officer Officer

(Green Belt) (Green Belt) (Green Belt) (Green Belt)

Six Sigma Organization Structure
- Other Example-
Managing Director
Implementation Regional Master

Committee
Black Belt
Department Mgr (Champion) Department Mgr
(Implementation Champion)
Section Mgr Section Mgr Section Mgr Section Mgr

(Black Belt-Part Time)
(Black Belt-Part Time)
Engineer Officer Officer

(Green Belt) (Green Belt)

Six Sigma Roles - Overview
Senior Executives Set direction and provide
resources
Implementation Plan and support
Committee organisation-wideimplementation
Set up projects and deploy teams

Champions
Master Black Belts and Coach and support team leaders

Black Belts
Execute projects
Black Belts, Green Belts
and Project Teams
Projects Review

Black Belts
Role
• Lead Six Sigma projects.
• Coach green belts on their projects.
• Trainers of certain Six Sigma tools.
Profile
• University education, 5 years working experience.
• Respected by peer and management.
• Good interpersonal and analytical skills.

Green Belts
Role
•Serve as a trained personnel who is able to lead
Six Sigma projects.
•Participate effectively in Black Belt’s project as team
member.
Profile
•Higher education level
•3 years working experience.
•Respected by peer.

Implementation Phases
Executive Briefing & Initial Assessment

Alignment
CTQs & Project Selection

Improvement Prioritisation
Black Belts & Green Belts Training

Skill Deployment

The Six Sigma Implementation Roadmap
10. Cont.
10. Cont.With
WithNext
NextProjects
Projects
9. 1st. Wave Projects Completed
8. Blacks Belts & Green Belt Trained

7. Projects Identified (1st. Wave)
6. Performance Drivers Identified
5. Champions Trained
4. Implementation Plan Developed
3. Six Sigma Committee Appointed
2. Six Sigma Objective Ascertained
1. Executive Trained

Training Courses Overview
Green Belt
Executive
Senior
Concepts in Quality
Six Sigma Overview
Implementation
Define Projects
The DMAIC Approach
Statistics Foundation
Measurement System Analysis
Quantitative Data Analysis
Process Mapping and Analysis
Team Facilitation Skills
Project Coaching
• Main Dashboard Development
• Project Presentation
Master Project
Overview
Insert here, project registration, team,

target, time frame (master project)
and possible saving in currency
119
Main objectives current
condition
4,000
target
3,000
2,000
1,000
-
Oct Nov Dec Jan Feb Mar Apr May Jun Jul
Productivity Target
Month AMPOULE Running Mc No Days Gross MOH Productivity Target

Oct 34,655,188 18 31 13,392 2,588 2,400
Nov 30,877,376 18 29 12,528 2,465 2,400
Dec 33,077,689 18 30 12,960 2,552 2,400
Jan 29,083,553 18 30 12,960 2,244 2,400
Feb 29,027,974 16 28 10,752 2,700 2,400
Mar 33,332,028 16 31 11,904 2,800 2,400
Apr 22,622,459 16 28 10,752 2,104 2,400
May 29,359,756 18 31 13,392 2,192 2,400
Jun 26,819,667 18 29 12,528 2,141 2,400
Jul 27,771,215 18 30 12,960 2,143 2,400
120
Objective Cascading
Cascade the objectives,
Main what is the most Target
1
contribute factors to the Sub
Objectives Project 1
main objectives
Target
Sub 2
Project 2
Target
Sub 3
Project 3
Target
Sub 4
Project 4
List possibility GWR gain Project Feasibility
Possibility Difficul Bene Time
No Sub Project Description No Sub Project Cost
Gain tness fit frame
1 Transport 3% 1 Transport
2 Dimension 3% 2 Dimension
3 Visual 2% 3 Visual
4 Setup 3%
4 Setup 121
Main Dashboard Monitoring
NO Sub Project Name Master Plan Pro Sub Project Overall

gres Achievemen Achieveme
s t nt
3 3 3 3 3 3 3 3 3 3 Target Last Current
1 Transportation reject
reduction (hyperlink
0 1
D 2 3
A
4 5 6 7 8 9
C Last
review status
review
to detail project M I Current
report) Status
1. Use this dashboard for monitoring the whole

projects anytime we doing presentation to the top
management
2. Put the hyperlink on the sub project name, to go to
detail presentation of sub project, and return back to
this slide after presentation of sub project.
3. always up date the score on last review and current
status tab to show the actual progress upon
completion some task on the projects
122
Monitoring process
4,000
3,000
2,000
1,000
1. Use this graph to view the trend of the improvement
-
Oct Nov Dec Jan Feb Mar Apr May Jun Jul
Productivity Target
123
Project Samples
Project Define Project coaching is a

Measure step by step guide
approach to clients so
Analysis
they would capable to
Improve
run improvement
Control project
Overview of project samples

124
Go to Lean
Introduction to Lean

Lean & Waste defined
“Lean is the application of a set of principles to identify and

eliminate waste and deliver to the customer what they
want when they want it”
“Waste is any activity which absorbs resources but
creates no value.”
What is Lean Thinking ?

“Lean is an organisational culture that believes it is possible to do
more and more with less and less while providing the customer
exactly what they want”

Understanding Waste
People
Waiting
Motion
Conveyance
Processing
Types of Inventory Quantity

Defects Waste
Quality Over
Production
Planning
Execution
Scheduling
Information
Source : William Laureau - KCG
Lean Thinking
Lean thinking can be summarised into five principles:
• Specify Value of specific product or service

• Identify Value stream for each product or service
• Make Value Flow without interruption
• Let the customer Pull value from the producer
• Pursue Perfection
Pull Value
Value
Flow Stream
Perfection
How is Lean Thinking Different ?
Traditional Thinking Lean Thinking
• Focus on Organisation • Focus on Customer

• Attack workers • Attack waste
• Allocate costs • Eliminate costs
• Make things complicated • Simplify
• Don’t learn from failure • Learn by Do
• Short term oriented • In for the long haul

Lean Journey
VSM waste elim
Pull System
Set Up Reduction
TPM & OEE
5S

The Benefits of Implementing Lean
Business Results - QCD Profit & Loss Account $
• Quality Sales Revenue
– Rework On-time delivery
• Cost Specials & New Products
– Inventory Reduction
– Productivity Cost of Sales
• Delivery Defects/Errors
– Responsiveness Inventory /WIP
– Flexibility People
Profit

The Benefits of Implementing Lean
People Results
•Cleaner, safer working environment

•Critical Thinking
•Skills Development
•Team-working
•True empowerment
•An easier working day

Introduction to Lean Sigma

Introduction to Lean Sigma
• What is Lean
1. History of Lean
2. Lean Thinking
3. 7 Wastes
4. Introduction to lean tools : 5S, TPM, VSM, Kan Ban
• What is Six Sigma

1. History of Six Sigma
2. Why we need six sigma
3. Introduction to DMAIC
4. Introduction to Six Sigma Tools
• Why we need Lean Sigma

1. Synergy of Lean Sigma
• Sample Project of Lean Sigma

Lean Sigma Structure

Lean Sigma Learning Path
Phase 4: Control
2 Level Design Matrices
Procedure for Conducting DOE
Screening Experiments
Phase 3: Improve Modeling Experiments
Constraint Management Process Control
Flow Based Manufacturing and Cell Variable Control Charts
Design Attribute Control Charts
Load Leveling Total Productive Maintenance
Phase 2: Analyze Kanban and Pull Extended Value Stream
Process Variation Reduction Standard Works
Failure Modes & Effect Analysis
Kaizen Blitz
Cause and Effect Analysis Correlation and Regression
Phase 1: Define and Measure Confidence Level and Confidence
Solutions Identification, Evaluation
Lean Sigma Overview Interval and Implementation Planning
The DMAIC Improvement ProcessHypothesis Testing
Introduction to DOE
Value Stream Mapping Analysis of Variance Kaizen Blitz: Lean Game (Lego)
Define: Setting Up Project Chi-square Test of Independence
Team Formation 5S Workplace Organization
Data Collection Plan Set Up Reduction (SMED)
Introduction to Minitab Mistake Proofing (Poka-Yoke)
Understanding and Describing Mini DMAIC Project: Catapult
Variation
Graphical Tools
Measurement System Analysis
Probability and Distribution
Process Capability Study

Lean Sigma
Combines the strategy and solution sets inherent
in Lean with the cultural, organizational process and
analytical tools of Six Sigma.
with the result that we …
respond to our customers better, faster

with less waste
Six Sigma
Lean

Milestones

Milestones
High Hanging
Fruits
Bulks Of
ISO 9001 Fruits Six Sigma
Approach
5S implementation
Low Hanging
Fruits QCC & 7 Basic
TPM implementation Tools
Common Sense &

Ground Fruits Intuition
JIT Manufacturing
Six Sigma Process Improvement
Lean Improvement
Six Sigma Improvement
Culture Change Waste removal Process Improvement

Organizational Infrastructures
Roles & Training
Responsibilities Program
Senior Executives Senior Executives
Six Sigma Working Group Champion

Champion, MBB, BB, GB
BB / GB/MBB
Project Teams, SGA
SGA
Finance Representative
Lean Sigma
Trainers Personal Selection
Implementation
Laptops Incentive System Schedule
Project Selection
Meeting Rooms Training
Project Savings Calculation Schedule
Software Projects Tracking System
Resources Policies Implementation Plan

A Simple Lean Solution Case 1
Manufacturing
Lean solution on Production Line
Lean Solution is started with Gemba (Field exercise), see the Gembutsu (Actual Fact)
and take action base on common sense
Benefit of this kind of improvement sometimes is uncountable. But very essential on
cultural changes and gain commitment from all persons.
As number of kaizen increase, the benefit will be increase and following the Toyota law.

A Simple Lean Solution Case 2
Ingredients Manufacturer
Lean solution on raw material storage
•Change on the way of thinking on the LEAN could makes us realize that determine the critical
control point is not as easy as determine the process flow. In the process flow, we could know
where the biological contamination could come, but in actual world (Gemba Gembutsu) , it could
be anywhere.
•Left picture shows the arrangement of raw material. Does it Safety ?
•Right picture shows something horror able in the clean room. Does it normal ?
(remark : now, this condition is improved)
Kanban: A Simple Real Case Study Case 3
Burger
Kitchen Regulator Tills Customer
As one type of burger is consumed . . .

They are removed from the regulator . . .
And then replenished by the kitchen . . .
Not made to a forecast and pushed at the customer
Benefit of Kan Ban improvement is reduce number of inventory, controlling the shelf live
and JIT delivery
Kan ban is good to implement where customer demand is predictable,
short time and reasonable shelf live

Big Lean Improvement Case 4
Stamping Factory
Inventory reduction and Pull system (production as customer demand) could give an
ultimate benefit to company. As an inventory become liquid, it is a cash
money that essential for operational in company
Before Lean
Can
I I Canning
Making
Current
Can
Canning
Making

Introduction to People Development

PEOPLE DEVELOPMENT
(Soft Skills)
Human Resources are the most important asset in every organization. To support the
organization well, the Human Resources should be equipped with relevant technical and
soft skills.
Soft skills are the skills related with People Behavior and Internal Capability, such as the
way a person interacts, leads, communicates, learns and thinks in a work situation.
There are 9 aspects of Soft Skills, namely:

Leadership, Communication, Trust, Teamwork, Motivation, Competence, Learning,
Commitment and Collaboration.
PD2 Enhance your Business Presentation Skills

PD3 Supervisory Management - Preparation for Profesional Manager
PD5 Communication and Leadership Skills - Lead a Team to Success
PD6 Training for Trainer - The Essential Knowledge and Skill
<< Home Public Training >>

Malcolm Baldrige National
Quality Award
• Recognition of US organization for Performance
Excellence in area of
• Business
• Health Care
• Education
• Non Profit Sectors
• Malcolm Baldrige is name of US Secretary of commerce
during Reagan Administration
• Objectives is for increase performance excellence for US
Organization
Properties of Malcolm Baldrige
• Use by US goverment for their awareness

for quality improvement in US organization
• Award is yearly distributed
• Adopt by overseas organizatin as a model
for business excellence
Award Recepient 2010
NO Organization Sector
Medrad, warrendale PA Manufacturin g
Nestle Purina Pet Care, St Louis , MO Manufacturing
Freese and Nichols, Fort Worth , TX Small Business
K& N management, Austin , TX Small Business
Studer Group, Gulf Breeze, FL Small Business
Advocate Good Samaritan Hospital, Healt Care
Downers Groove, IL
Montgomery County Public School, Education
Rockville, MD
Criteria for Performance
Excellence
1. Leaderships
2. Strategic Planning
3. Customer Focus
4. Measurement, analysis and Knowledge
management
5. Workforce Focus
6. Operation Focus
7. Result
Leaderships
• Examine how senior executives guide the organization

• Customer Focus Organization
• Learning Oriented Climate
• Visible Values
• High Expectation
• Strategic, system and method for achieve organzational
excellence
• Organization responsibility to public
• Good Citizenship practice
Strategic Planning
• Strategic Directions
• Determination of Key Action Plan
Customer and Market Focus
• Determine requirement and expectation of

its customer and markets
• Build relationships with customers
• Acquire, satisfies and retains customers
Measurement, Analysis and
knowledge management
• Effective use, analysis, and improvement
of data and information
• Performance management system
Human Resources
• Enables the workforce

• Align workforce with organization’s
objectives
Process Management
• Design, managed and Improve of

• Production
• Delivery
• Support process
Core Values
• Visionary Leaderships
• Customer Centered
• Organizational and Personal Learning
• Valuing staff and partners
• Agility
• Focus on the future
• Managing the Innovation
• Management by Fact
• Public Responsibility and citizenship
• Focus on result and creating value
• System Prespective
Business Result
• Evaluate organization’s performance and improvement in its key
business area
• Customer satisfaction
• Financial and market place performances
• Human resources
• Supplier and partner
• Performance
• Operational Performances
• Governance and Social Responsibility
• Organization perform relative to competitors
Model for Implementation
1. Improve Management System

• Visionary
• Performance Management
• Management System
2. Improve Documentation
3. Implementation
4. Assessment
Neville Clarke System Development Methods
Documentation Strategy
The Implementation of Lean

& Six Sigma Project
Development
Neville Clarke System
Development Methods
The Implementation of
Management Systems
Project Management Method
<< Home >>

Documentation
Management System
Strategy

Management System Requirements
Customer
Work Instructions
process 1 context Diagram procedure Policy & Forms

process 2 context Diagram Policy & Forms
process 6 process 3 procedure Work Instructions

context Diagram Policy & Forms

context Diagram Policy
Customer & Forms
Business
Process Procedure Company Support
Manual Manual
Documentation Manual
Directives and SOP


VENDOR
SUB-CON
PURCHASING
DELIVERY WARE
DELIVERY
PRODUCTION HOUSE CUST.
MATERIAL
PLANNING
QUALITY
CUST. MARKETING PRODUCTION MAINTENANCE
REQ.
PLAN
COST ESTIMATE
PRODUCTION
PROJECT ENGINEERING
ENGINEERING
TOOLS MAKING
CTRL OF
DEFECTIVE
CUSTOMER
C.A. & CTRL OF BUSINESS MANAGEMENT
FINANCE SATIS- IQA HRD
P.ACTION DOC’s PLANNING REVIEW
FACTION

VENDOR
SUB-CON PURCHASING
7.4
DELIVERY WAREHOUSE DELIVERY

PRODUCTION 7.5, 8.2.4 7.5, 8.2.4 CUST.
MATERIAL
PLANNING
MARKETING QUALITY PRODUCTION MAINTENANCE

CUST.
REQ. 7.2 PLAN 7.1 7.5, 8.2.4 6.3
COST ESTIMATE PRODUCTION

PROJECT ENGINEERING
ENGINEERING 7.1 7.3
TOOLS MAKING
CTRL OF
DEFECTIVE
8.3
CTRL OF CUSTOMER
C.A. & BUSINESS MANAGEMENT
DOC’s SATIS- AUDIT HRD
P.ACTION FINANCE PLANNING REVIEW
4.2.3, FACTION 8.2.2 6.2
8.4, 8.5 5.4 5.6
4.2.4 8.2.1

Business Process and KPI
inquiry MPS Product

Planning Production
KPI : KPI :
Internal : Internal :
Planning Lead Time Man Hour
Customer : Customer :
Effective Plan Quality Product
On Time Production

Objective Cascading
what is the most contribute Target
Main Objectives : factors to the main Sub KPI
1
Quality Product objectives Transport
Target
Sub KPI 2
Dimension
Target
Sub KPI 3
Visual
Target
Sub KPI 4
Setup

4 Setup 3%
4 Setup 167
Typical Structure of
Management Systems Documentation
Vision Company Policy

Mission Process Descriptions
Company Reference to procedures
Policy
Objectives Manual
ISO 9001/14001/OHSAS 18001
Responsibilities
Who,What,When
Procedures Where
ISO 9001/14001/OHSAS 18001
Work Instructions How

ISO 9001/14001/OHSAS 18001
Support Documentation
ISO 9001/14001/OHSAS 18001

Cascade Document
Manual Level (policy) Procedural Level Operational Level (SOP)
Purchasing Mgr SOP Test Report Evaluation

Our organization only
select supplier base on Select 3 Supplier s 1. Select Characteristic
their capability and Bidding List that critical to quality,
quality. refers back to drawing
and find * symbol
Purchasing Mgr 2. Evaluate the Cpk value
only for characteristic
Evaluate that related to the fit,
-Product Samples function and safety
- Test Report
- Supply capacity
- Delivery Time

Cascade Document
Level 1 Level 2 Level 3
Purchasing Policy Pr Vendor Selection SOP Sample evaluation
SOP Part approval process
SOP Quality Rating
Pr Purchasing Process SOP General Purchase
SOP Spare part purchase planning
Pr Vendor Audit
Sample of Integration
Company Manual, base on
Company Business Process
Related Document Shows Policy Statement of

link to level 2 Forwarder Hiring method is
documentation base on Company Process,
ISO 9001 and OHSAS 18001

Lean and Six Sigma
Project Development

Lean and Six Sigma
Project Development
• Project driven
• Team oriented rather than individual
approach
• Structured by Teams and coordination
among Teams

The Project Cycle
Initial asessment :
Understand the
current situation The project Pattern :
• Training • Initial assessment
Upgrade the
•
Knowledge
• Training
• Periodic assessment • Project Coaching
• Understand the • Periodic
improved situation
• Project coaching
Assessment
• Upgrade the skills

Assessment

Gemba Assessment
Gemba Assessment is on site assesment to
ensure assessor has real understanding on
real subjects
To understanding We have to check Then we can

the quality of the site where the understand the
product products are made quality level

Lean Assessment Focus
ORGANIZATIONAL
ENVIRONMENT
THEORY OF CONSTRAINT WORKPLACE

ORGANIZATION
MATERIAL CONTROL WORK STANDARIZATION
TOTAL PRODUCTIVE
PERFORMANCE METRICS MAINTANANCE
CONTINOUS
QUICK CHANGEOVER IMPROVEMENT
ERROR PROOFING

On Site Assessment
(Gemba Assessment)
• The on site assessment to deeply understanding where is the

current position of the organization
• Picture above show Neville Clarke consultant give a gemba

assessment in Kenya, Africa

Lean Project Coaching

Project Coaching
Development of master Dashboard
5S and TPM as fundamental system

5S intro TPM Intro
Value stream mapping for improve processes

Value Stream Mapping
Lean for Non Manufacturing :

Programme almost similar, less on TPM, key point is the VSM will run a
strong role on improvement
Case Study Lean in Non Manufacturing
Lean in the office
Houshin Kanri
5S as fundamental focus on documentation
Value Stream Mapping
Response Time
Deliver Time
VSM in the Lean Office

Case Study Lean in the Office

Neville Clarke Strategic
Management Programme
NC Strategic Management
Management System
Excellence Models : TQM, SWOT
Objectives Management
Houshin Kanri - Ballance Scorecard – Six sigma
Continuous Improvement
Profit and Growth

Excellence Models : TQM
8 management 5 Stack Holders Excellence

principles criteria
• Customer
• Customer Focus • Share holder
• Leaderships • Effectiveness and
• Employee
• People involvment
• Supplier Efficiency of process
• Process approach •Baldrige 7 criteria
• Society
• System Approach • Deming 14 points
• Contionuous
Improvement
• Factual approach on
decission making
• Supplier Mutual
Benefit
TQM Tools
Analysis & Planning System

Improve
• Vision Mission •Assessment
• SWOT •Ballance criteria : Balridge,
• Competitor Scorecard SQA, ISO 9004
Analysis • Houshin Kanri • Business
• BPR • Business Plan Continuity
• Six sigma & Management
Lean
Objectives Management
Houshin Kanri - Ballance Scorecard

Growth
Revenue
Profit
Sales
Business New Product
Plan New
Business New Customer
Objective B
Process Based objectives
Ballance Scorecard – customer – internal – finnance – growth
Ballance Metrics – Effectiveness and Efficiency

Process Approach and
Objective Deployment
Customer Inquiry Product Distribution Plan
Distribution
Process
Customer Aspect : On Time Delivery (Eff)
Internal Aspect : Distribution Time(Efc)

% fulfillment (Eff)
Financial aspect : Distribution cost (Efc)
Growth : Customer Number, Items Number

Continuous Improvement
Profit and Growth
Business
Plan
D M A I C
Establish objectives and dashboard
Monitoring, Measurement and Analysis
Systematical process on objectives

achievement
Factual & analytical Approach on decission
making
Objective Cascading
Main what is the most Target
1
contribute factors to the Sub
Objectives Project 1
main objectives
Target
Sub 2
Project 2
Target
Sub 3
Project 3
Target
Sub 4
Project 4
4 Setup 3%
4 Setup 189
NC Strategic Management Services
Training concept
Assessment : TQM Criteria
Coaching : Objectives Achievement

Questions and Answer
Project Coaching

Project Coaching

Project Coaching

Project Coaching

Project Coaching

Project Coaching

Project Coaching

Management systems

MS Implementation Strategy
Phase 1
Current System Appraisal

 Evaluate Existing
Procedures & Practices
Phase 2
Phase 2
Strategy Planning
 Establish Implementation Plan
 Form Steering Committee, Working Parties & Working Groups
System Design
 Design Integrated Business Process
 Map MS Requirements
 Develop Procedure & Work Instruction Pipeline
System Development
 Establish Company-wide Procedures and Support
Documentations to meet Requirements of MS including
Integrated Risk Assessment and Program
Phase 3
Phase 3
System Implementation
 Advice, Support and Assistance in
Smooth Implementation
Performance Indicators
 Establish Key Performance Indicators to
measure Improvement
Phase 4

Phase 4
System Audit & Review

 Conduct Internal MS Audit
 Fine Tuning to ensure Effectiveness, Practicality &
Conformance to MS Standard
Certification

Certification
Assessment
 Certification by a third-party body

Project Management Method

Project Management Principles
• Following the clear step by step
implementation schedule
• Clear guidance on every implementation
phases
• Structured internal project management

Management System Implementation
principles
Characteristic Effect
• Improved system and
• Customized process
implementation strategy • System easy to maintain
- “auto-pilot”
• Right methodology for
documentation • Ownership
- Natural business flow • Self-sufficient
as foundation
• Participation
• Training oriented
• Happy and Motivated
Employee & Management
• Satisfied Customer
DIRECT CONSULTANCY
Neville-Clarke Company
Project Project Steering
Manager Manager Committee
Consultant WP WP WP
Implementation Plan

Effective project program & customized
project time frame
COMPANY : PT CMKS Indonesia START :
LOCATION : EJIP Industrial Park Plot no 7E
PROJECT SCOPE : TS 16949 END :
NO ACTIVITIES 1st 2nd 3rd 4th 5th 6th 7th RESPONSIBILITY RESPO NSIBILITY
1 System Appraisal 0 NC/All Employee NC/All Employee

2 Project Launching 0 NC/BOD/QMR/SC/WP NC/BOD/QM R/SC/WP
3 Training in ISO9000 0 NC/QMR/SC/WP NC/QM R/SC/WP
4 Training in Business Process (BP) 0 NC/QMR/SC NC/QM R/SC
5 Training in Context Diagram (CD) 0 NC/QMR/SC NC/QM R/SC
6 Review BP & CD 0 NC/QMR/SC NC/QM R/SC
7 Training in Customer Satisfaction 0 NC/QMR/SC/WP NC/QM R/SC/WP
8 Review PD 0 NC/QMR/WP NC/QM R/WP
9 Review Support Documentation 0 NC/QMR/WP NC/QM R/WP
10 Finalize QMS Documentation I 0 NC/QMR/SC NC/QM R/SC
11 Preparation in Procedure Implementation 0 NC/QMR/SC/WP NC/QM R/SC/WP
12 Procedure Implementation 0 All Employee All Employee
13 Training in Quality Manual (QM) 0 NC/QMR/SC NC/QM R/SC
14 Review QM Process Policy Statements 0 NC/QMR/SC NC/QM R/SC
15 Conduct Procedure Testing 0 NC/All Employee NC/All Employee
16 CA Support from Procedure Testing 0 NC/QMR/SC/WP NC/QM R/SC/WP
17 Training in Internal Quality Auditing (IQA) 0 NC/IQ Auditor NC/IQ Auditor
18 Conduct Internal Quality Auditing (IQA) 0 IQ Auditor IQ Auditor
19 IQA support 0 NC/IQ Auditor NC/IQ Auditor
20 CA - IQA 0 NC/QMR/SC/WP NC/QM R/SC/WP
21 Conduct Management Review Meeting 0 BOD QMR/SC/WP BOD QM R/SC/WP
22 Conduct Pre-Assessment (Phase 4) 0 NC/All Employee NC/All Employee
23 Corrective Action from Pre-Assessment 0 NC/QMR/SC/WP NC/QM R/SC/WP
24 Finalize QMS Documentation II 0 NC/QMR/SC/WP NC/QM R/SC/WP
25 Conduct Project Management Review 0 QMR/PM QM R/PM
26 Application to Certification Body 0 QMR QM R
27 Certification Audit Support 0 Cert. Auditor Cert. Auditor
28 CA Support from Certification Audit 0 NC/QMR/SC/WP NC/QM R/SC/WP
29 IQA support (after Certification) 0 NC/QMR/SC/WP NC/QM R/SC/WP
0

Clear guidance
DAILY CONSULTANCY VISIT REPORT
reported by Ari Hariadi
Step by step project
Date :
Company :
implementation
Purpose :
A) Pre-Consultancy Remarks
Clear report on each

phases
B) Consultancy Activities
Description of work done Client Seen
Clear guidance
through detail
schedule and
reports
Follow-up Actions required Action by
Next Consultancy visit on :

Purpose :
MR (signature)

Internal Project Management
Consultants
Projects A Location
Plan
Operational Consultants
Projects B Management Monitoring
And Guidance
Consultant Operational
Managers
Technical
Projects C
Support

Maximum control and support
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Up date knowledge through regional
connection
OUR SERVICES
Consultancy
In-House Training
Public Training
<< Home >>

OUR SERVICES – Consultancy
• ISO 9000
• ISO 14000
• QS-9000
• ISO/TS 16949
• OHSAS 18000
• HACCP
• Six Sigma
• Lean Manufacturing
<< Home Our Services >>
Post Consultancy Services
-Regular Client Seminar-
• SMMT Seminar
• Lean Leadership Seminar
• OHSAS Seminar
• ISO/TS Update Scheme
Seminar
• 6 Sigma Client Gathering

PARTNER – Interactive Newsletter

Mailing List :
nevilleclarke_indo@yahoogroups.com

OUR SERVICES – In House Training-

OUR SERVICES – Public Training
•Lean Sigma •Environmental Management System
•Lean Manufacturing •Safety Management System

•Six Sigma
•Integrated Management System
•Quality Management System
•SMMT Approved Courses •Food Safety Management System
•Quality Management System for •People Development

•Automotive Industry
•Information Security Management
System

LEAN-SIGMA
Performance Excellence
through Simplicity & Consistency
Six Sigma and Lean have been recognized as two different best practices for improving the
performance of business processes. Six Sigma focuses on reducing process variation as a
way to improve the capability of a process to meet customer requirements. Whereas Lean
focuses on eliminating process wastes in order to increase productivity and speed up
processes.
PERA Academy has effectively integrated the principles and tools from Six Sigma and Lean
to form the Lean-Sigma approach. Lean-Sigma combines the strengths of Six Sigma and
Lean and provides a more powerful approach for process improvement.
Lean-Sigma courses are delivered under coordination with PNC Academy, United Kingdom.
SS3 Lean-Sigma Understanding

LEAN MANUFACTURING
Big Results with Less
“Lean” refers to a paradigm of providing services or manufacturing products that continuously minimizes
waste and maximizes the flow of value to the customers.
Service providers and manufacturing facilities, more often than not, operate under sub-optimal
conditions, tolerating unnecessary costs resulting from waste. Examples of waste are: waiting, excessive
motion, unnecessary conveyance, over production, over processing, high inventory, excessive and
irrelevant information, errors, rejects, repairs and rework.
Such waste consumes potentially productive resources, reduces the resource capacity and incurs cost
to the organization, thus significantly reducing bottom-line profits. In addition, they do not contribute to
customer value and become barriers to the value creation processes in the organization.
Lean Manufacturing courses are delivered under coordination with PNC Academy, United Kingdom.
L1 Lean Thinking - Big result with less

L2 Value Stream Mapping
L101 Workplace management with 5S approach (with video and case study)
L102 Optimize Productivity through Total Productive Maintenance (TPM)
L103 Effective Supply Chain Management for Improving Profit

SIX SIGMA
A Key to Success
The benefits of Six Sigma can be summarized in five keywords: Cheaper, Faster, Better leading to
Improved Profitability and Organizational Excellence.
Six Sigma depends on tried-and-tested (proven) management methodology that helps organizations
make more money by improving the processes. It is the basis for a best-in-class philosophy that
demands long-term, business strategy.
The fundamental objective is to establish a measurement-based strategy to focus on systematic

process improvement and variation reduction. It aims for virtually error free business performance.
Waste and cost are driven out as quality improves, while customer satisfaction is increased through
continuous improvement in quality and delivery performance.
Six Sigma courses are delivered under coordination with PNC Academy, United Kingdom.
SS2 Six Sigma Understanding

SS9 Six Sigma - Yellow Belt
SS10 Six Sigma - Green Belt
SS11 Six Sigma - Black Belt

QUALITY MANAGEMENT SYSTEM
ISO 9001:2008
The ISO 9000 series is designed to be a generic standard applicable to any type and size of organization in
the service, manufacturing, public administration and government sectors.
ISO 9001:2000 is a part of the ISO 9000 series of standards which specifies the requirements for an
organization’s Quality Management System (QMS).
QMS03 ISO 9000:2008 Series Auditor/Lead Auditor with LIVE AUDIT and Accelerated Learning
Method (IRCA/IPC Reg. A17047)
QMS04-0 ISO 9000:2008 Series QMS Internal Auditor with Accelerated Learning Method
QMS04-1 ISO 9000:2008 Series QMS Internal Auditor with Simulation and Accelerated Learning Method
QMS33 ISO 9000:2008 Series QMS Advanced Auditor - Value Added Approach
QMS56 ISO 9000:2008 Series Overview & Analysis
QMS58 Managing QMS Project Implementation and Maintenance
QMS60 Effective QMS Documentation Management including Paperless Documentation System
QMS70 Effective Problem Solving Techniques & Tools
QMS72 Developing, Measuring, and Monitoring Organization's Performance Indicator

ISO/IEC 17025:2005
ISO/IEC 17025:2005; General Requirements for The Competence of Testing and

Calibration Laboratories, specifies the general requirements for the competence
to carry out tests and/or calibrations, including sampling. It covers testing and
calibration performed using standard methods, non-standard methods, and
laboratory-developed methods.
QMS61 ISO/IEC 17025 Overview and Analysis

QMS62 Effective Calibration System

FOR AUTOMOTIVE INDUSTRY
ISO/TS 16949:2009
ISO/TS 16949:2009 is a set of technical specifications developed specifically for application in

automotive and automotive-related industries. It is developed by the International Automotive
Task Force (IATF) and the Japan Automobile Manufacturer Association (JAMA) and supported by
ISO/TC 176, the ISO technical committee entrusted to undertake standardization in the field of
quality management. Based on major industry standards such as ISO 9001:2008 QMS, AVSQ,
SMMT, EAQF, QS-9000 and VDA6.1; ISO/TS 16949, when established and implemented provides a
common approach to quality management system, thereby, reducing multiple certifications.
AMS102 ISO/TS 16949:2009 Analysis & Conversion

AMS103 ISO/TS 16949:2009Process Approach Internal Auditing. Trainer is SMMT approve tutor.
AMS105 Statistical Process Control (comply with AIAG SPC reference manual 2nd edition)
AMS107 Measurement System Analysis with workshop
(comply with AIAG MSA reference manual 3rd edition)
AMS108 APQP, PPAP, FMEA - Concept & Implementation

SMMT APPROVED COURSES
PERA Neville-Clarke is the Southeast Asia representative for SMMT IF (SMMT

Industry Forum), the approved Lead Auditor training provider to the SMMT.
SMMT (Society of Motor Manufacturers and Traders) is one of the five
approved International Automotive Task Force (IATF) oversight bureau.
AMS58 ISO/TS 16949:2009 Supplier Lead Auditor Certification (SMMT

IFApproved)

ENVIRONMENTAL MANAGEMENT SYSTEM
ISO 14001:2004
ISO 14000 is a series of international standards on environmental management system.

Compliance to environmental regulations through risk assessments, program
management, environmental monitoring and control is also one of the key activities
involved in ISO 14000.
EMS101 ISO 14000:2004 Series EMS Concept and Implementation

EMS102 ISO 14000:2004 Series EMS Internal Auditor
EMS03 ISO 14000:2004 Series EMS Auditor/Lead Auditor
(IEMA Approved - In association with Marsden International (UK) Ltd)

SAFETY MANAGEMENT SYSTEM
OHSAS 18001:1999 l Behavioural Safety
OHSAS 18001 - Occupational Health and Safety Management System, helps an organization
ensure the safety of its workers through the management and control of its OH&S risks when
running its business operations.
SMS101 OHSAS 18001 Internal Auditor

SMS102 OHSAS 18001 Concept and Implementation
SMS103 SMK3 Concept and Implementation
SMS106 Safety Leadership and Safety at Work
SMS108 Accident/Incident Reporting & Investigation
SMS109 Emergency Response and Preparedness
OHS05 OHSAS 18001 Lead Auditor
(In association with Marsden International (UK) Ltd - IRCA Reg. A17267)
Behavioural safety is the systematic application of psychological research on human behaviour to

the problems of safety in the workplace. Many companies have experienced significant falls in
their accident rates within six to twelve months as a direct consequence of implementing
behavioural safety techniques. Currently, behavioural safety has been adopted by many
organizations including Du Pont, Bayer, Chevron, et cetera to reduce the rate of accidents.
SMS111 Behavioural Safety Management System Concept and Implementation

INTEGRATED MANAGEMENT SYSTEM
Quality, Environment, Health & Safety
An IMS (Integrated Management System) is a system that allows for the effective management
of a suite of business issues in realizing the long-term goals of an organization.
In an IMS, different systems are harmonized, therefore making them easier to manage. Multiple
audits and certifications are also prevented; helping to reduce costs, save time and minimize
disruption in business oprations.
The future for Management Systems seems likely to become progressively integrated. This is
driven by the pursuit of excellence and the need to be competitive as companies look
towards implementation of more management systems that increasingly evolve.
IMS102 Understanding, Developing, Implementing and Maintaining an Integrated QHSE

Management System
IMS301 Integrated QHSE Internal Auditor

FOOD SAFETY MANAGEMENT SYSTEM
ISO 22000:2005
ISO 22000:2005, Food Safety Management Systems - Requirements for Any

Organization in The Food Chain, specifies the requirements for a food safety
management system in the food chain where an organization needs to demonstrate
its ability to control food safety hazards in order to provide consistently safe end
products that meet both the requirements agreed with the customer and those of
applicable food safety regulations.
FMS101 ISO 22000:2005 HACCP Concept and Implementation

FMS102 HACCP Internal Auditor

PEOPLE DEVELOPMENT
(Soft Skills)
Human Resources are the most important asset in every organization. To support the
organization well, the Human Resources should be equipped with relevant technical and
soft skills.
Soft skills are the skills related with People Behavior and Internal Capability, such as the
way a person interacts, leads, communicates, learns and thinks in a work situation.
There are 9 aspects of Soft Skills, namely:

Leadership, Communication, Trust, Teamwork, Motivation, Competence, Learning,
Commitment and Collaboration.
PD2 Enhance your Business Presentation Skills

PD3 Supervisory Management - Preparation for Profesional Manager
PD5 Communication and Leadership Skills - Lead a Team to Success
PD6 Training for Trainer - The Essential Knowledge and Skill

INFORMATION SECURITY MANAGEMENT SYSTEM
ISO 27000:2005
Information Security is the preservation of confidentiality, integrity and availability

of information. The ISO 27001:2005 standard explains how the all-too-common and
oftenly devastating business impacts covered by viruses, website outages,
improper disclosure of customers account details and incorrect pricing
information are addressed.
ISMS1 Introduction, Understanding, Documenting and Implementing

Information Security System ISO 27001:2005

Industrial Management
Industrial management series is a training focus on development skills which essentially

required in the industry
This is developed base on specific industry requirement in Indonesia and developed with
the combination of theory and best practice from multi national companies
IM 01 Practical Marketing Management

IM 02 Pracctical Quality Assurance Management
IM 03 Purchasing management
IM 04 Production planning
IM 05 Practical Maintenance Management
IM 06 SA 8000 introduction
IM 07 Project Management Introduction
IM 08 Finance for non finance
Project Management
• Objectives
Benefit of project managmeent
Lifecycle of a project
Apply project management methodology
• Scope
• Manufacturing new product release
• Services Industry new product release
• Construction project
• Level
• Basic Introduciton
Project Management
• Sylabus
• Project management fundamental
• Project Objectives
• Resources Planning
• Risk Assessment
• Project Timing Plan
• Planning
• Excecution
• Sign off – commissioning
• Project Management tools
• QFD
• Gant Chart
• PDPC
• Case Study
Project Management
Duration
3 Days training
2 days theory
1 day : Workshops and role play
TRAINING PATHWAY TO QUALITY MANAGEMENT SYSTEM (QMS)
UNDERSTANDING, DEVELOPMENT, INDUSTRY BEYOND BEYOND

IMPLEMENTATION AND SPECIFIC COMPLIANCE: COMPLIANCE:
MAINTENANCE OF ISO 9001 QMS STANDARDS IMPROVEMEN EXCELLENCE
T
START HERE QMS 57 / QMS 60 QMS 72
ISO/TS 16949 Six Sigma
Effective ISO 9001 Key Performance
For Automotive Training Series
QMS Indicators
Industry (Code: SS)
Documentation Development
QMS 56
ISO 9001 Quality QMS 62 QMS 70
Management ISO 13485 Lean
Effective Effective Problems
System Overview For Medical Training Series
Calibration System Solving
Devices (Code: L)
Techniques and
QMS 04 Skills
ISO 9001 QMS HACCP, GMP and AMS 105 Lean Sigma
Internal Auditor ISO 22000 Statistical Process Training Series
Course For Food Safety Control (SPC) (Code: SS3)
QMS 03
IRCA Registered ISO 9001 QMS QMS 71
AS 9100 Total Quality
Auditor/Lead Cost of Quality
With LIVE Audit For Aerospace Management
Auditor Course (On Demand
Industry (TQM)
Training)
(On Demand)
QMS 58 QMS 59
ISO 9001 Quality Customer Customer
Management Reps Satisfaction TL 9000 PD Series Relationship
(QMR) Skills Measurement For Telecom Soft Skills Training Management
Industry (On Demand)
<< Home >>

TRAINING PATHWAY TO QUALITY MANAGEMENT SYSTEM
FOR AUTOMOTIVE INDUSTRY (AMS)
<< Home >>

TRAINING PATHWAY TO ENVIRONMENTAL MANAGEMENT SYSTEM
(EMS)
<< Home >>

TRAINING PATHWAY TO SAFETY MANAGEMENT SYSTEM (SMS)
<< Home >>

Our Client
At Neville-Clarke,
we believe in providing
quality service
to all our clients
<< Home >>

Our Client
OUR CONSULTANT
INTEGRATED MANAGEMENT SYSTEM OF ISO 9001 & ISO 14001
Asno Horie Indonesia, PT Mecoindo Schlumberger, PT

Dupont Powder Coatings Indonesia, PT Metito Indonesia, PT
Freyabadi Indotama, PT Ondeo Nalco Indonesia, PT
Gemala Kempa Daya, PT Panarub Industry, PT
Hirose Electronics Indonesia, PT Saitama Stamping Indonesia, PT
Hitachi Consumer Products Indonesia, PT Sanken Transformer Indonesia, PT
Haldin Pacific Semesta, PT Sanyo Indonesia, PT
Indofarma Tbk, PT Sika Indonesia, PT
Indonesia Teijin Films/Indonesia Dupont Film, PT Takita Manufacturing Indonesia, PT
KAO Indonesia, PT Teijin Indonesia Fibber Corp. Tbk, PT
Koba Tin, PT Toppan Sampoerna Indonesia, PT
Mattel Tools Indonesia, PT Tri Dharma Wisesa, PT
Multi Bintang Indonesia Tbk Wika NGK Insulator, PT
(Jakarta & Surabaya), PT 3M Indonesia, PT
<< Home >>
Our Client
HACCP – ISO 22000 Food Safety Management System
Amerta Indah Otsuka, PT Multisari Langgeng Jaya, PT

Armita Abadi, PT Multi Bintang Indoesia, PT
Foodex Inti Ingredients, PT Pacific Agritama Comoditi, PT
Greenfields Indonesia, PT Pacific Indo Dairy, PT
Haldin Pacific Semesta, PT Pacific Medan Industry - Plantation, PT
Java Peppers Indonesia, PT Prakarsa Alam Segar, PT
Madusari Nusaperdana, PT Tata Nutrisana, PT
Marizarasa Sarimurni, PT
<< Home >>

Our Client
ISO/TS 16949 Quality System
Armstrong Industri Indonesia, PT Induktorindo Utama, PT

Asno Horie Indonesia, PT Inti Ganda Perdana, PT
Braja Mukti Cakra Jumbo Power International, PT
Coats Rejo Indonesia (Pasuruan Site), PT Metindo Era Sakti, PT
Delphi Automotive Industries, PT NSK Bearing Indonesia, PT
Denso Indonesia Corp., PT Nusaraya Putramandiri, PT
Goodyear Indonesia, PT Polymatech Indonesia, PT
Gemala Kempa Daya, PT Saitama Stamping Indonesia, PT
Hamaden Indonesia, PT Wahana Eka Paramitra, PT
Hestrindo Sentosa, PT Shin Heung Indonesia, PT
Indoyoke – Surabaya, PT
<< Home >>

Our Client
OHSAS 18000/SMK3
Amerta Indah Otsuka, PT Nusaraya Putramandiri, PT
Amoco Mitsui PTA Indonesia Metito Indonesia, PT
BAT Indonesia (British America Tobacco), PT Ondeo Nalco Indonesia, PT
Cipta Krida Bahari, PT Panarub Industry, PT
Freyabadi Indotama, PT Prima Nur Panurjwan, PT
Filtrona Indonesia, PT Pipamas Putih, PT
Kao Indonesia, PT 3M Indonesia, PT
Koba Tin, PT Tangguh Samudera Jaya, PT
Kemenangan, PT
<< Home >>

Our Client
Property Developer & Management

Ciputra Surya, PT
Duta Pertiwi, PT
Manunggal Wiratama, PT
Mandiri Dipta Cipta, PT
Metropolitan Retailmart, PT
Summarecon Agung Tbk, PT
Lippo Karawaci
Jababeka , PT
Pacific Palace , Shopping Mall
Sun Plaza, Medan, Shopping Mall
<< Home >>
Our Client
ISO/IEC 17025 (SNI 17025) QUALITY LABORATORY SYSTEM
Indorama Synthetics Tbk, PT

PAM Lyonnaise Jaya (PALYJA), PT - Laboratory
PAM Lyonnaise Jaya (PALYJA), PT - Meter Testing
Mecoindo Actaris Indonesia
Trieka Labs, PT
Nutricia Sejahtera, PT
Arnott , PT
<< Home >>
Our Client Six Sigma
Indosat M2 – TQM with Six sigma

Indorama
MutuGading Textile
Great Giant Pinnaple
Jago Furniture Jogjakarta
Bakrie Group
Guntner Indonesia
Indokodsa
Bayer Pharmaceutical
Indo Rama
Badjatek
<< Home >>
Our Client Six Sigma
Jago Furniture-Yogyakarta
-Reduce Lead Time by 50%, implement kan ban system
-Reduce Inventory value 30%
- Increase production capacity by 50%
- Increasing People Competence
Bajatek-Bandung
Increase productivity output by 5% (kg/man hour)
Decrease reject by 10%
Increasing people competence
Clear objective deployment
Clear data collection
Energizer Indonesia (Lean Sigma)
Reduce inventory by 1 million US$
Gain space and reduce 2 outside warehouses
5S and TPM implementation
Increase productivity
<< Home >>

Our Client Lean
Energizer International
(Indonesia, Singapore, Malaysia, Philiphine, China,Sri Lanka,
Egypt, Kenya, UK, Switzerland, USA)
Playtech USA – Ormand Beach , FL, USA
Shick Milford, Connecticut , USA and Guang Zhou,China
Soncha FlashLight product, Shenzen , China
Quest International Indonesia and Egypt
Sepatu Mas Idaman
Great Giant Pinnaple, Dream Sentosa, Landson
Alstom Power , SC Jhonson Sby, Cognis, Kanefusa, Starbuck
(MAP) , SMART TBK, Yamaha Music, UIEU, Abbott, Cocacola,
Multibintang
<< Home >>

What Our Client Say
“We would like to thank you from the bottom of our hearts for your very systematic guidance to
our team in preparing the ISO9001 certification. Your experienced staffs are very helpful go the
successful completion of this project within 9 months. We hope that we can work with you again
in other project.”
-PT Bintang Toedjoe-

“Neville-Clarke, the chosen Management Consultant has provided us with a lot of
guidance and support through their deep understanding of ISO9000 requirements and
knowledge to interpret the requirements for hospital industry. Their consultants have
guided our team to conduct activities from the preparation, implementation to corrective
actions in a very professional way. The success of the mutual relationship has put our
hospital, RUMAH SAKIT MITRA KELUARGA JATINEGARA, as the first certified Hospital in
Indonesia, which achieves the ISO 9002 Certification for all the hospital and healthcare
services,....”
-Rumah Sakit Mitra Keluarga-
“We would like to express our gratitude for your contribution to the successful completion of our
ISO9001 project. We are so terribly impressed by the business process approach to organize the
documentation system which is applied by Neville-Clarke. It is really practicable and applicable! You
obviously widened the perspective of our staffs.”
-PT Trimitra Baterai Perkasa-
<< Home >>

Our Consultant
Our consultants are not academics in
ivory towers, but experienced
professionals with hands-on practice
in various industries. Because of
this,we understand your business
concerns and goals, and always
provide workable solutions. As
professionals driven by results, we
strive to ensure that all clients gain
from our partnership.
<< Home >>

Daud Yogasara
Country Manager , Senior Consultant
Daud Yogasara is one of the senior consultant in Neville Clarke Indonesia. Currently he is a country
manager for Indonesia. Prior to join Neville Clarke, he has wide experiences in automotive industry as
a production engineer. He was also having a managerial experience in leading fine ceramic
industry as a deputy factory manager.
Daud Yogasara has strong technical knowledge combining with managerial skill thats very essential
during serving his clients. His strong technical knowledge educated from Institute Technology
Bandung and enrich with working experiences in Japan in one of leading automotive company in
Japan.
As professional consultant, Daud Yogasara hold many professional recognition from international
bodies such as Certified Six sigma Black Belt from American Society for Quality, Certified Quality
Manager from American Society for Quality, QMS 9000 Lead Auditor from IRCA, SMMT ISO TS 16949
Approve tutor and Lean Master from PERA Academy.
Along his service with Neville Clarke, Daud Yogasara has develop and train many organization for
ISO 9001, ISO 14001, OHSAS 18001, ISO TS 16949, Six sigma and Lean, and people development
specific in the Industrial area. He was handle various industry such as Energizer International, Shick
International, Playtec, Asuransi Astra, Guntner, NGK Busi, Quest International, Sanyo Compressor, SC
Jhonson home hygine, Mattel indonesia, PT Dok Perkapalan etc. He also doing some consultation
and assessment for the Lean Manufacturing in Overseas country such as UK, Switzerland, Egypt,
Singapore, Malaysia, China, Kenya, Sri Lanka, Philiphine and USA.
<< Home >>

Budi Setiawan
Six Sigma Black Belt
Budi Setyawan is one of the consultant in Neville Clarke Indonesia. Prior to join Neville Clarke,
he has long experiences in MATSUSHITA TOSHIBA, a leading Japan electronic manufacturer in
the world, posted in Manufacturing Engineering Department. Excellent managerial skill
proudly brought him as Engineering Manager who main responsible was to improve process
and quality. He held Six Sigma Black Belt.
Budi Setyawan has strong technical knowledge combining with managerial skill that very
essential during serving his clients. His strong technical knowledge was educated from
Institute Technology Bandung and enhanced with working experiences in Japan company.
As professional consultant, Budi Setyawan hold some professional recognition from
international bodies such as QMS 9000 Lead Auditor from IRCA, OHSAS 18001 Lead Auditor
from IRCA.
Along his service with Neville Clarke, Budi Setyawan has developed and trained many
organization for Six Sigma, Lean, Problem Solving, ISO 9001, ISO 14001. He handled various
industries both manufacturing and services either large or small companies, private or owned
state companies such as Bakrie Metal Group, Gramedia Printing, SOHO Group, Komatsu,
Polypet Karyapersada, Sarana Prima Nusantara Abadi, PLN, Pelindo, Musica Studio’s,
Manulife Insurance.
<< Home >>

Dedy Pabelu
ISO 9001,OHSAS 18001,EMS 14001 Lead Auditor
Mr.Dedy Pabelu was graduate as Electrical Engineer majoring Telecommunication from Institut Sains
Teknologi Nasional .
Over 4 years loyal, quality and hands-on Mangement Innovation Group as an Asst.Mgr, experience
with progressively greater responsibilities. Having developed and implemented strategies that can
be improved productivity and quality yield, increased operator performance, and enhanced
customer satisfaction. Held Six Sigma Black Belt proficient to use six sigma methodologies as an
analytical tools for problem solving in LG Philips Displays Indonesia
He provise consultancy service for the development and implementation of ISO 9000 Quality System
in a wide range of industries, conducting Audit of Appraisal and Pre-Assessment of Quality System
based on Six Sigma methodology and ISO 9000 Standard, Environment Management System based
on ISO 14000 and Safety Management System base on OHSAS 18001 and also a trainer of Neville
Clarke’s training.
Consultancy & Audit Experience :
SPC – Assessment : Medan Bajaindo
ISO/SNI 17025 : PAM Lyonnaise Jaya (PALYJA), Freyabadi Indotama
SMK3 Permenaker : Jasa Marga Tbk,Amerta Indah Otsuka
ISO 9001 : Cipta Krida Bahari, Surya Multi Indopack, Bukit Muria Jaya, Metito
Indonesia
<< Home >>
Costing & Budget
<< Home >>

Neville Clarke Benefit
• Flexible payment
– No Down Payment for most services
– Payment base on delivered services
• Flexible services
– Welcome on customize services
• Number of consultant utilization days
• Pay for utilize jobs only
– Welcome on customize to budget services
<< Home >>

Customizing the Project
• Choose the correct materials, suitable

consultant level and choose the correct
programme will result the maximum
value
• Contact us for detail (here)
<< Home >>

Customizing the Project
• Choose the correct materials, suitable

consultant level and choose the correct
programme will result the maximum
value
• Contact us for detail (here)
<< Home >>

Contact Us
Neville Clarke Indonesia had the wide range of
product as of Quality, Safety, Environment,
Management and Leadership that was proven
among the clients from Manufacturing, Oil &
Gas, Mining and Service industries.
Jakarta Office : Website : http://www.nevilleclarke.com

PT Neville-Clarke Indonesia
Jakarta Office
Menara MTH, 11th floor
Jl. MT Haryono Kav. 23
Jakarta Selatan
Jakarta 12820
Tel: 62 21 5359001
Fax: 62 21 83782557
Email : enquiry.nci@nevilleclarke.com
Contact:
<<Home >>
Lia Roliawati
Thank You

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•PERA International

•What Our Client Say

•Cost & Budget

Pera Integrated Training Pera Technology Pera Asia Pacific

<< Home >>

• Business expansion to Asia Pacific

1992 • Opened office in Bangkok, Thailand

• Business expansion in Malaysia; another office in Penang

1995 • Opened first office in China, Beijing

1996 • Acquired by PERA Consulting

1997 • Another office in Malaysia, Johor Bahru

1998 • Opened first office in Indonesia, Jakarta

• Corporate branding as Pera Neville Clarke

2007 • NCI manage by local management

• One of the largest international consulting firm in Asia Pacific

Expand internally to Acquire the knowledge and

Execute the projects to realize the benefits.

Explore Evaluation Education Execution Expansion Engagemen

Management Organisational Performance

United Singapore Malaysia China Indonesia Philippines

Management System ISO/TS 16949

HACCP & ISO 22000

Operational Excellence Lean

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• An internationally recognised series of

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• ISO 9000 Quality Management

1 Scope 7 Product realisation

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Model of the process-based quality management system

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• Standardization and Simplification

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1. Scope 4.4 Implementation and operation

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Implementation and Operation

•Internal Audit •Emergency preparedness and response

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• Enhance company’s image

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• Internationally-recognized Occupational Health &

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1. Scope 4.4 Implementation and operation

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Continual Improvement OH&S Policy

Management Review Planning

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• Reduce legal liability

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• Aims to be an International Automotive Standard

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• Harmonization of customer requirements for International

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Model of the process-based quality management system

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• Standardization and Simplification

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• APQP PPAP Control Plan

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