ISO 9001 2015 EFQM Lean Six Sigma Integration

1. Santosh Bhosale
Director-Operational Excellence
Achieving Breakthrough
Improvements through
ISO/EFQM / Lean Six Sigma
integration

2. 2
Agenda
Quality management system and its evolution
Lean Six Sigma ( LSS ) introduction
Transition from ISO 9001:2008 TO ISO
9001:2015
Linkage between ISO 9001 and Lean Six Sigma
Integration of ISO 9001:2015 with Lean Six
Sigma
Benefits of Lean Six Sigma
01
02
03
04
05
06

3. 3
Quality management
system and its evolution
01

4. 4
Quality Management System
Management System to direct & control an organization with regard to quality.

5. 5
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Quality Evolution
Before 1700
Craft Production
1750-1900
Industrial
Revolution
Quality
Inspection
1900-1920
Quality Control
1920-1940
Mass
Production
Quality
Assurance
1950 -1970
Quality
Engineering
1970-2000
TQM
ISO 9000 series
Six Sigma
TPM
Excellence
Models EFQM,
Baldridge etc..
2000-2010
New ISO
standards
BPR
Lean
Lean Six Sigma

6. 6
Quality Evolution Time lines
1700: Craft production
1750 to 1850 : Industrial revolution
1900 : Scientific Management ; Division of labor, Time and motion studies etc..
1920 : Introduction of statistical control charts
1930 : Ford Mass production Model T
1940 : World War II created increase in emphasis on quality control. The US Army used Statistical Sampling
Techniques.
American Society for Quality Control was formed.
1950’s – Quality movement evolved into quality assurance (emphasis on product design & incoming raw
material, greater involvement of upper management
1960’s- The concept of “zero defects” . (Motivation of employees, expectation of perfection from each
employee) Taguchi Quality Engineering
1970’s- A global impact on quality. Toyota production system.. TQM initiatives
1980’s – ISO 9000 series for QMS
1990’s- Six sigma and TPM
2000’s – Lean / Theory of constraints / BPR
2010’s – Lean Six sigma in Manufacturing Services / transaction . Integrated Lean six sigma deployment

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Overview of Lean Six
Sigma
02

8. 8
What is Lean Enterprise
Lean is a leading edge technology which aims to identify and reduce or eliminate “ Lean Wastes” ( non
value added activities ) in any service or manufacturing environment ( regardless of size or industry ) by
using systematic Lean tools.
Waste & Value
Motion
14%
Overprocessing
8%
Rework & Repair
10%
Transportation
12%
Waiting
18%
Overproduction &
Excess Inventory
22%
Adding Value
6%
Unutilised Human
Resources
10%

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Lean Focus: Speed – “Flow”
Eliminate
Waste NVA
Steps
Traditional processes have many
steps...
LEAN processes focus on
eliminate delays between the
value adding steps ...
Reducing
1. Throughput time
2. Inventory
Total steps = 25
Value Add steps = 3
Waste NVA steps = 22
Total steps = 9
Value Add steps = 3
Waste NVA steps = 6
1
2
3
End
Start
1 2
Start
3
End
= Value Add operation
= Non Value Add operation
= Transportation
= Wait, queue, storage
9

10. 10
The Lean Enterprise
• Lean companies use less of everything than do
more traditionally managed companies:
– half the human effort in the factory,
– half the manufacturing space,
– half the investment in tools,
– half the engineering hours to develop a new product in half the
time,
– less than half the inventory,
*From Womack, Jones, et.al.,
“The Machine that Changed the World.”

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Six Sigma - Strategy

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Six Sigma Focus: Capable Processes: No Rejects
• LEAN requires predictable, repeatable processes = low
variability (within customer specification)
• Processes that have low variability are called Capable Processes
• Capable Processes have minimal waste and zero defects
• Variability exists in most processes
• Processes that have high variability (beyond the customer
specifications) are called Incapable Processes
• Incapable Processes have significant waste and defects or require
unproductive and unplanned rework0
5
10
15
20
25
30
0
5
10
15
20
25
30
0
5
10
15
20
25
30
Upper
Specification
Limit
Lower
Specification
Limit
12

13. 13
Cost of Poor Quality and Sigma
COPQ Sigma PPM Position
20-25% of Sales 2.0 308,530 Non Competitive
15-20% of Sales 3.0 66,807 Average Company
10-15% of Sales 4.0 6,210
5-10% of Sales 5. 0 233
<5% of Sales 6.0 3.4 World Class
Six Sigma is a Standard of Performance.
It means not more than 3.4 Defects per Million Opportunities

14. 14
Six Sigma - DMAIC Strategy
DMAIC is a data driven quality strategy for
improving processes and an integral part of a
six Sigma quality initiative. DMAIC Is the
Acronym for 5 phases of Six Sigma as given
below:-
Define, Measure, Analyze, Improve, Control

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DFSS- DMADV approach

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Six Sigma Process Approaches- DMAIC and DMADV

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Six Sigma DMAIC - Overview

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The breakthrough strategy
Each phase is designed to ensure that :-
• Companies apply the breakthrough
strategy in a systematic way.
• Six Sigma projects are systematically
designed and executed
• The results of these projects are
incorporated into running the day-today
business.

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Strategies at various levels
• Executives at the business level can
use Six Sigma for improving market
share, increasing profitability and
organizations long term viability.
• Managers at operations level can use
Six Sigma to improve yield, reduce
cycle time and reduce the labor and
material cost.
• At the process level engineers can use
Six Sigma to reduce defects and
variation and improve process
capability leading to better customer
satisfaction.

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A metric that demonstrates quality
levels at 99.99967% performance for
products and processes
Optimize Process Performance ; Align with Customer Needs
A practical application of statistical
“tools” to help measure, analyze,
improve, and control processes
A rigor to define/improve processes that
incorporate customer feedback and to ensure
processes meet customer needs
Customer Centricity
Process Capability
Variation
A philosophy of working smarter so that we
make fewer mistakes and eventually no
mistakes at all !!
Philosophy
Metric
Tool
Rigor
Data Driven
What is
Six Sigma?

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21
Lean
Reduce cycle time by eliminating waste
throughout the value stream
Increase reliability and output by
eliminating defects in process and
packaging operations
Speed & Efficiency Precision & Accuracy
Six Sigma: Vertical view focused on variation
Lean: Horizontal view focused on time
Six Sigma
Lean versus Six Sigma

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1960 1970 1980 1990 2000 2010
Self steering teams -> High Performance Organization
6 Sigma & Design for 6 SigmaTotal Quality Management ->
Total Productive Maintenance -> Total Perfect Manufacturing
Toyota Production System -> Just In Time -> Lean
Build on previously validated systems
Japan
West
IntegratedLean6
Sigma
People
Quality
Cost
Delivery
World Class Manufacturing concepts
Integrated Lean 6 Sigma

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Combining Lean and 6 Sigma
23
Lean
Eliminating Waste in Processes
“Process Driven – Use Mapping”
Lean
Six
Sigma
Six Sigma
Eliminating Variation in Processes
“Data Driven- Use Statistics”
Goal – Reduce Waste &
Increase Speed
Focus – Bias for Action, proven
Tools to reduce Non-Value-Add
Method – Map the Processes,
Quick Wins, Kaizen Events
Projects
Goal – Improve performance on Critical To
Customer Requirements
Focus – Use repeatable approach for
sustained results, Reduction in Variation
Method – Intense Focus on Data
Typical done as a project, DMAIC
Roadmap, performance a linked to
KPI’s
•Lean Speed enables Six Sigma Quality (Faster cycles of Experimentation / Learning )
•Six Sigma Quality Enables Lean Speed (Fewer Defects means Less Rework)

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Transition from ISO
9001:2008 to ISO
9001:2015
03

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What is improvement
The ongoing improvement of products,
services or processes through incremental and
breakthrough improvements

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The ultimate aim of any management system is continual improvement of its
performance. To achieve this, Deming’s PDCA cycle of improvement is
interwoven in the structure of the ISO 9000 standards.

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Steps to Continual Improvement
According to ISO, the application of this principle involves:-
I. Employing a consistent organization-wide approach to continual
improvement of the organization’s performance.
II. Making continual improvement of products, processes and systems an
objective for every individual in the organization.
III. Establishing goals to guide, and measures to track, continual
improvement.
IV. Providing people with training in the methods and tools of continual
improvement.
V. Recognizing and acknowledging improvements.

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Future Relevance of ISO 9001:2008
(9001 WW Survey Result)

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Reasons For The Changes
▪ In the last 25 years, many other Management Systems Standards have come into use
world wide
▪ Organizations that use multiple Management System Standards are increasingly
demanding a common format and language that is aligned between those standards
▪ Decrease the emphasis on Documentation
▪ Increase the emphasis on Achieving Value for the Organization and its customers
▪ Increase emphasis on Risk Management to achieve objectives

30. 30
World-Wide Survey - Key User Inputs
• ISO 9001, as it is, must change to continue be relevant
• Integrate with other Management Systems (EMS etc.)
• Provide one integral approach to the management of
the organization for Leadership commitment &
understanding, strategic planning, management buy-in
• Include tools and risk management

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▪ Emphasis on continual improvement
▪ Constant focus on preventive actions
▪ Root cause analysis and weak preventive actions
▪ Use of process approach
▪ Handling of Customer Complaints
ISO 9001—Its relevance and impact in Asian Developing Economies:
Project initiated by UNIDO, funded by Norad and supported with
technical inputs by ISO and the IAF.
Survey results -Weak Areas of Implementation

32. 32
ISO 9001 - New Concept Importance
How important is it to incorporate the following concepts into ISO 9001?

33. 33
Resource Management
ISO 9001:2008
Introduction
Scope
Normative Reference
Terms and Conditions
Quality Management System
Support
ISO 9001:2015
Introduction
Scope
Normative Reference
Terms and Conditions
Quality Management System
Management Responsibility
Product Realisation
Measurement, Analysis &
Improvement
Planning
Leadership
Operation
Performance Evaluation
Improvement

34. 34
Linkage between ISO
9001 and Lean Six Sigma
Methodology
04

35. 35
Parameter ISO 9001 TQM / Lean Six Sigma
Framework
A framework to create “ improvement
thinking”
A framework to achieve improvement and to link it to
profitability
Purpose
Purpose Provides an equitable basis for
assessing how organizations can effectively
meet customer and applicable regulatory
requirements
It is used for contractual, certification
and/or assessment purposes
Achieves sustainable business growth and profitability
by improving and/or innovating processes, products
and services that maximize the value delivered to the
customers .
Scope Scope Defines the requirements for a QMS
Makes use of a set of strategies, methodologies, tools
and metrics to improve business performance .It is
used to optimize performance and maximize
profitability
Leadership
Leadership Management responsibility is
promoted by the establishment and
communication by the establishment and
communication of the quality policy and
objectives.
Requires leadership to aim at highest performance
with highest profitability, creating an organizational
structure for implementation , communication and
review activities
Model PDCA model
DMAIC or a DFSS roadmap, which are extensions of
PDCA
Techniques/ tools Does not specify Specified toolbox Extensive tool box based on the type of problems
Linkages of ISO 9001 and TQM / LSS approach for continual improvement

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Integration of ISO
9001:2015 and Lean Six
Sigma Methodology
05

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ISO 9001 : 2015 QMS Principles

38. 38
Linkages of QMS Principles and available LSS tools
S. No. QMS Principles Linkage with LSS approach tools
1 Customer focus
VOC, VOB, Customer complaint analysis, Kano
model
2 Leadership Organisation structure for LSS deployment,
3 People Engagement
Organization structure for LSS deployment,
Kaizen, Suggestions schemes, Quality Circles,
Cross Functional team
4 Process Approach
Projects linked to strategy, Cross functional
teams working, KPI linkages
5 Improvement Kaizen, Kaizen Events, DMAIC / DFSS projects
6 Evidence approach to decision making
Statistical / Basic 7 QC tools , Data based
thinking
7 Relationship management
Involvement of suppliers in DMAIC / DFSS
projects, KPIs for Out sourced processes

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39
Principle 1: Customer Focus

40. 4040
Principle 2: Leadership : Lean Six Sigma Organization Structure
unity, purpose, and involvement*

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Principle 3: People Involvement

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42
Principle 4: Process Approach
...related resources and activities are managed as

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Principle 5: Improvement
...the object of an organization that wishes to stay in business.*

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Principle 6: Evidence based Approach...
based on.. analysis of data and information.*

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Principle 7: Relationship Management
enhance the ability of the organization to create value.*

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Similarities Clause Wise– ISO 9001 2015 and Lean Six Sigma
ISO 9001
2015
clause no.
Scope
LSS Approach / Tools / techniques
4
Context of the organization
Understanding the organization and its context
Needs and requirements
Stake holders analysis, VOC, VOB, SWOT, PESTEL,
Business case
5
Scope
Management System
Leadership
Management commitment
Policy Roles, responsibility and authority
Organization structure for LSS deployment. E.g.
Sponsors, Champions, Process owners, YB, GB, BB ,
MBB etc..
6
Planning Actions to address risks & opportunities
Objectives and plans to achieve them
FMEA, FTA, QFD, Hoshin Kanri deployment / X matrix,
CAP, Benchmarking
7
Support
Resources
Competence
Awareness
Communication
Documented information
Competency mapping, Belt selection, Toll gate
reviews, Visual Controls, Visual displays, Project
documentations, KPI deployment, Knowledge
management, Reward and recognition, Suggestion
schemes, Quality Circles

47. 47
Similarities Clause Wise – ISO 9001 2015 and Lean Six Sigma- Contd..
ISO 9001
2015
clause no.
Scope
LSS Approach / Tools / techniques
8
Operation
Operational planning and control
DFSS / DMADV approach/ Process mapping, Cause and effect
matrix, FMEA, Control plans, Measurement system analysis, DOE,
Pokeyoke, Statistical Process Control, OEE, OTIFEF
9
Performance evaluation
Monitoring, measurement, analysis &
evaluation
Internal audit
Management review
Balance score card, KPI monitoring and analysis, Toll gate reviews
, Gemba walk, Control plans, MSA
10
Improvement
Non conformity and corrective action
Continual Improvement
Kaizen, Kaizen event, Kanban, DMAIC , PDCA, Breakthrough
improvement

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Moments of Fact –ISO Standards and Lean Six Sigma
ISO standards Scope
Covered in
ISO 9001
Covered in
LSS
Phase / DMAIC
ISO 13053-1:2011 ( 2 parts ) Quantitative methods in process improvement -
- Six Sigma -- DMAIC methodology Yes Yes All
ISO 18404:2015
Quantitative methods in process improvement -
- Six Sigma -- Competencies for key personnel
and their organizations in relation to Six Sigma
and Lean implementation Yes Yes
Hoshin Kanri deployment ,
Project selection, Team
formation, Organization
structure
ISO 18414:2006
Acceptance sampling procedures by attributes --
Accept-zero sampling system based on credit
principle for controlling outgoing quality Yes Yes All
ISO 14560:2004
Acceptance sampling procedures by attributes --
Specified quality levels in nonconforming items
per million Yes Yes Measure / Control
ISO 7870:2014 ( 5 parts) Control charts Yes Yes All
ISO 22514:2013 ( 8 parts ) Statistical methods in process management --
Capability and performance Yes Yes All
ISO 14051:2011
Environmental management -- Material flow
cost accounting -- General framework Yes Yes
Major tool for ISO 14000
related DMAIC projects
ISO 9004 2009 Managing for the sustained success of an
organization -- A quality management approach Yes Yes Yes

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Factual Benefits of Lean
Six Sigma
06

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51. 51
1986-2001 Motorola Saved $16 billions
1996-2004 GE saved $15 billions
1998-2000 Honeywell saved $2 billions
2000-2001 Ford Saved $ 1billion
Over the past 20 years Lean Six sigma saved Fortune 500
companies an estimated $427billion
Lean Six Sigma Cost savings

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The adoption of Lean operating principles and techniques is a characteristic of most ‘world class’ companies. Specific examples would
include Toyota & Dell Computer.
Benefits:
Tangible: Ranges:
Improved Customer Service Level (Delivery) to 99%
Increased Throughput (Sales) 10 - 50%
Reduced Lead Times 25 - 75%
Reduced Inventories (RM, WIP, FG) 25 - 75%
Reduced Costs (Scrap/rework, Over Time, Headcount, etc) 10 - 50%
Improved Profitability (ROI) 10 - 25%
Improved Quality (combined with 6 Sigma projects) to 6 Sigma
Improved flexibility and speed to market
Intangible:
Awareness and alignment of the entire organization of the business strategy
Aligned business: from Customer -> to -> Supplier
Multi-skilled, flexible, empowered, committed and efficient workforce
More orderly workplace operating in a standardized environment
Benefits of Applying Lean Six Sigma Principles

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What’s next for the
Organizations

54. 54
▪ Knows what is going on and is ready to implement the new requirements
▪ Takes full advantage of the revision of ISO 9001 to improve business performance
through integration with Lean Six sigma strategy.
▪ Integrate their activities within the scope of multiple Management System
Standards
▪ Adds value by Improving People and process capability and achieve profitability
and revenue through Quality improvement initiatives.
Organization need to ensure that it …

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Excellence – An
Endless Journey

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Thank you !!! Let’s discuss