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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)

<< Home Introduction to NCI Product >>


ISO 9000:2008 Series

• ISO 9000 Quality Management


Systems:
Fundamentals and Vocabulary
• ISO 9001 Quality Management
Systems:
Requirements
• ISO 9004 Quality Management
Systems:
Guidance for Performance
Improvements
• ISO 19011 Guidelines on Quality and
Environmental Auditing
<< Home Introduction to NCI Product >>
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

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


Introduction to ISO 14000

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


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
4.6 Management review

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


Why Implement ISO 14001?

• Enhance company’s image


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

<< Home Introduction to NCI Product >>


Introduction to OHSAS 18000

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


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
4.6 Management review

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


Introduction to ISO/TS 16949:2009

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


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.

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


ISO TS 16949 Core Tools

• APQP PPAP Control Plan


• FMEA
• SPC
• MSA
• Customer specific requirement

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


ISO TS 16949 SPC

• Variable
• Xbar R
• Xbar S
• X MR
• Atrribute
• P chart
• NP chart
• C chart
• U chart

<< Home Introduction to NCI Product >>


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

Pera Neville-Clarke, 2009


Slide No 36 AMS105 (BI) Issue 6, Jan 2009
Process Capability Analysis

Didapat dari
within
subgroup
variability

Didapat
dari
standard
deviation
dari the
data

Pera Neville-Clarke, 2009


Slide No 37 AMS105 (BI) Issue 6, Jan 2009
ISO TS 16949 MSA

• Variable
• Short Method Xbar –R
• Long Method Xbar – R
• Anova Method
• Attribute
• Apraisal Agreement
• Gauge Performance Curve

<< Home Introduction to NCI Product >>


Repeatability

Repeatability

Good Repeatability Bad Repeatability

<< Home Introduction to NCI Product >>


Reproducibility
Reproducibility

Operator A B C

A B C A B C

Good Reproducibility Bad Reproducibility

<< Home Introduction to NCI Product >>


Gage R&R

• Estimate the combined variation of


repeatability and reproducibility.

σ 2
GRR σ 2
reproducibility σ 2
repeatability

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


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.

<< Home Introduction to NCI Product >>


Consequences for the Company

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

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


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.

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


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.

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


Comparisons

ISO 22000

HACCP

- GMP
- PRP

Food Safety Management System

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


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.

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


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


<< Home Introduction to NCI Product >>
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

<< Home Introduction to NCI Product >>


What is GMP?

GMP, according to FDA regulations, are


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

<< Home Introduction to NCI Product >>


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.

<< Home Introduction to NCI Product >>


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
<< Home Introduction to NCI Product >>
4.1 Definition (21 CFR 110.3)
Definition of term which used on the GMP

<< Home Introduction to NCI Product >>


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

Pera Neville-Clarke International, 2005


Slide No 65 GMP Issue 1
Jul 2005 Rev 0 Jul 2005 << Home Introduction to NCI Product >>
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.

Pera Neville-Clarke International, 2005


Slide No 66 GMP Issue 1
Jul 2005 Rev 0 Jul 2005 << Home Introduction to NCI Product >>
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.

Pera Neville-Clarke International, 2005


Slide No 67 GMP Issue 1
Jul 2005 Rev 0 Jul 2005 << Home Introduction to NCI Product >>
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

Pera Neville-Clarke International, 2005


Slide No 68 GMP Issue 1
Jul 2005 Rev 0 Jul 2005 << Home Introduction to NCI Product >>
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.

Pera Neville-Clarke International, 2005


Slide No 69 GMP Issue 1
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

Pera Neville-Clarke International, 2005


Slide No 70 GMP Issue 1
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.

Pera Neville-Clarke International, 2005


Slide No 71 GMP Issue 1
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

process 4 procedure Work Instructions


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

<< Home | Neville Clarke System Development Methods >>


Neville Clarke’s Business Process Approach
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

<< Home | Neville Clarke System Development Methods >>


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

<< Home Introduction to NCI Product >>


What is ISO 17025?

• Specific requirement to be met by


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

<< Home Introduction to NCI Product >>


The Principles

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

<< Home Introduction to NCI Product >>


Why is ISO 17025 needed ?

• Regulatory requirement

• Customers requirements

• Consumers expectation

• ISO 17025 system is verifiable & auditable

• Good Management of Laboratory (GLP)

<< Home Introduction to NCI Product >>


Benefits of ISO 17025

• Increase confidence in Laboratory Testing

• Effective and efficient deployment of


resources

• Cost effective control system

• Improve teamwork

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


Key point on ISO 17025
Implementation (3)
• Measurement Tracebility
• Traceable to international standard
• Data Processing

• Sampling Methodology

• Test Report
• Opinion on test report

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


What is ISO 17020

• Specific requirement to be met by


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

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


Starting Point

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

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


Why we need ISO 17020

• Regulatory requirement

• Customers requirements

• Consumers expectation

• ISO 17020 system is verifiable & auditable

• Good Management of Testing Bodies

<< Home Introduction to NCI Product >>


Benefit ISO 17020

• Increase confidence in Laboratory Testing

• Effective and efficient deployment of


resources

• Cost effective control system

• Improve teamwork

<< Home Introduction to NCI Product >>


Introduction to Six Sigma

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


Reducing CPQP
High Hanging Fruits

Bulks Of Fruits Six Sigma Approach

Low Hanging Fruits


QCC & 7 Basic Tools

Common Sense &


Ground Fruits Intuition

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


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)

<< Home Introduction to NCI Product >>


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)

<< Home Introduction to NCI Product >>


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
<< Home Introduction to NCI Product >>
Projects Review

<< Home Introduction to NCI Product >>


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.

<< Home Introduction to NCI Product >>


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.

<< Home Introduction to NCI Product >>


Implementation Phases

Executive Briefing & Initial Assessment


Alignment

CTQs & Project Selection


Improvement Prioritisation

Black Belts & Green Belts Training


Skill Deployment

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


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
<< Home Introduction to NCI Product >>
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

<< Home Introduction to NCI Product >>


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”

<< Home Introduction to NCI Product >>


Understanding Waste

People
Waiting
Motion
Conveyance
Processing

Types of Inventory Quantity


Defects Waste
Quality Over
Production
Planning
Execution
Scheduling

Information
Source : William Laureau - KCG
<< Home Introduction to NCI Product >>
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
<< Home Introduction to NCI Product >>
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

<< Home Introduction to NCI Product >>


Lean Journey
VSM waste elim

Pull System

Set Up Reduction

TPM & OEE

5S

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


The Benefits of Implementing Lean

People Results

•Cleaner, safer working environment


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

<< Home Introduction to NCI Product >>


Introduction to Lean Sigma

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


Lean Sigma Structure

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


Milestones

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


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


<< Home Introduction to NCI Product >>
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.

<< Home Introduction to NCI Product >>


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)
<< Home Introduction to NCI Product >>
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

<< Home Introduction to NCI Product >>


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

<< Home Introduction to NCI Product >>


Introduction to People Development

<< Home Introduction to NCI Product >>


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

<< Home | Neville Clarke System Development Methods >>


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

process 4 procedure Work Instructions


context Diagram Policy
Customer & Forms

Business
Process Procedure Company Support
Manual Manual
Documentation Manual

Directives and SOP


<< Home | Neville Clarke System Development Methods >>
Neville Clarke’s Business Process Approach

<< 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

<< Home | Neville Clarke System Development Methods >>


Neville Clarke’s Business Process Approach
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

<< Home | Neville Clarke System Development Methods >>


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

<< Home | Neville Clarke System Development Methods >>


Objective Cascading
Cascade the objectives,
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

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 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

<< Home | Neville Clarke System Development Methods >>


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

<< Home | Neville Clarke System Development Methods >>


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

<< Home | Neville Clarke System Development Methods >>


The Implementation of
Lean and Six Sigma
Project Development

<< Home | Neville Clarke System Development Methods >>


Lean and Six Sigma
Project Development

• Project driven
• Team oriented rather than individual
approach
• Structured by Teams and coordination
among Teams

<< Home | Neville Clarke System Development Methods >>


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

<< Home | Neville Clarke System Development Methods >>


Assessment

<< Home | Neville Clarke System Development Methods >>


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

<< Home | Neville Clarke System Development Methods >>


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

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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

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Lean Project Coaching

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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
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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

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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


NC Strategic Management
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
NC Strategic Management
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
NC Strategic Management
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


NC Strategic Management
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
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 189
NC Strategic Management Services

Training concept

Assessment : TQM Criteria

Coaching : Objectives Achievement


Questions and Answer
Project Coaching

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Project Coaching

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Project Coaching

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Project Coaching

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Project Coaching

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Project Coaching

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Project Coaching

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The Implementation of
Management systems

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MS Implementation Strategy

Phase 1

Current System Appraisal


 Evaluate Existing
Procedures & Practices

Phase 2
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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
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MS Implementation Strategy

Phase 3

System Implementation
 Advice, Support and Assistance in
Smooth Implementation

Performance Indicators
 Establish Key Performance Indicators to
measure Improvement

Phase 4

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MS Implementation Strategy

Phase 4

System Audit & Review


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

Certification

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MS Implementation Strategy

Certification

Assessment

 Certification by a third-party body

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Project Management Method

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

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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
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DIRECT CONSULTANCY

Neville-Clarke Company
Project Project Steering
Manager Manager Committee

Consultant WP WP WP

Implementation Plan

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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

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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)

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Internal Project Management
Consultants
Projects A Location
Plan

Operational Consultants
Projects B Management Monitoring
And Guidance
Consultant Operational
Managers
Technical
Projects C
Support

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Maximum control and support

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Up date knowledge through regional
connection
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OUR SERVICES

Consultancy

In-House Training

Public Training

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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

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Post Consultancy Services
PARTNER – Interactive Newsletter

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Post Consultancy Services
Mailing List :
nevilleclarke_indo@yahoogroups.com

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OUR SERVICES – In House Training-

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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

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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

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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

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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

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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

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QUALITY MANAGEMENT SYSTEM

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

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QUALITY MANAGEMENT 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

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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)

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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)

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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

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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

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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

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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

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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

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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)

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

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TRAINING PATHWAY TO ENVIRONMENTAL MANAGEMENT SYSTEM
(EMS)

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TRAINING PATHWAY TO SAFETY MANAGEMENT SYSTEM (SMS)

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

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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

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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

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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-

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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.

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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.

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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.

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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
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Costing & Budget

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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

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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:
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Lia Roliawati
Thank You