MANAGEMENT SYSTEMS
A DISCUSSION ON ISO, VALUE ADDED
MANAGEMENT SYSTEMS, THE PROCESS
APPROACH AND THE AUDIT
10/4/2015
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"Creative minds have always been known to
survive any kind of bad training."
Anna Freud
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Topics of Discussion……
Why are we here today?
Our Objectives
ISO…History and Purpose
Management Systems
The Process Approach
Management System Standards
14001
9001 & TS
An Auditee’s Perspective
An Auditor’s Perspective
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A Thought on Problem Solving
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Why are we here?
Share ideas on Management Systems
Discuss experiences
Evaluate perspectives
Practice makes perfect
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Our objectives today…
ISO…Speak the language and know the history
Why Management Systems & processes?
How to Add Value in a Management System
Client’s & Auditor’s perspectives and expectations
Share information, exchange ideas and payback!
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Our objectives today…
ISO…Speak the language and know the history
Why Management Systems & processes?
and Purpose
Client’s ISO…History
& Auditor’s perspectives
and expectations
Share information, exchange ideas and payback!
What does ISO stand for?
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ISO…History and Purpose
The International Organization for Standardization
Derived from Greek ‘ISOS’ meaning ‘equal’
International translation as ISO
World’s largest developer of Standards
Network of National Standards Institutes (NSI)
from 161 countries
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ISO…History and Purpose
Began in Electro-technical field as IEC in 1906
Drastic change due to post-war circumstances
The new ISO – 1947 – to oversee unification &
coordination of industrial standards
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ISO…History and Purpose
One member per country (NSI)
Central secretariat in Geneva, coordinates system
NGO
Unlike UN, members not delegates of
governments…but can be government mandated
Here at home, NSI is the SCC
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ISO…History and Purpose
Benefits to society…
Business – global supply chain based on specs
Customers – worldwide compatibility of technology
Governments – base for EH&S legislation
Trade – level playing field
Developing Countries – define expectations when
resources are limited
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ISO…History and Purpose
Benefits to society…
Consumers – conformity assures quality, safety
and reliability – makes life simpler
Environment – preservation & improvement
through air, water, soil, emissions, and radiation
standards
The ISO Brand – voluntary, market driven, equal
membership, consensus based and worldwide
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ISO…History and Purpose
Over 16,000 current standards for:
Agriculture to Construction
Medical & I.T.
Screw threads – from bikes to airplanes
Safety – symbols break language barriers
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The ISO Message
“International Standards have the power to connect the world's
peoples in coordinated activities addressing global issues. For
example, environmental management system standards work
toward global solutions by inviting all generations, including
children, to get involved within their own organizations.
In the end, all we produce are “documents”, strings of words
and symbols in print and electronic files. But documents can
change the world, giving people the chance to form a sense of
solidarity in working to solve global problems.”
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ADDRESS
by ISO PRESIDENT, PROF. MASAMI TANAKA,
29th ISO GENERAL ASSEMBLY
Ottawa, Canada
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13 September 2006
DEVELOPING THE STANDARDS
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The ISO Management System Standards
Developed by Technical Committees (TC) –
experts who will use the standards
TC acts as national delegation chosen by NSI
TC 176 – 9001:2000 – SCC
TC 207 – 14001 – SCC
Write draft of standard…ping pong…then vote
(unless in a hurry for publication – IWA, PAS, TS)
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Management Systems
Management System Defined –
What an organization does to manage it’s
processes and/or activities
MANAGEMENT SYSTEMS
Generic Management Systems Standards –
14001 Environmental
What is the definition of a Management System?
 9001 Quality
18001 H&S
19011 Auditing
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Management Systems
Management System Defined –
What an organization does to manage it’s
processes and/or activities
Generic Management Systems Standards –
14001 Environmental
 9001 Quality
18001 H&S
19011 Auditing
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Management Systems
Management System Defined –
What
an
organization
does
to
manage
it’s
MANAGEMENT SYSTEMS
processes and/or activities
Generic Management Systems Standards –
What are
the benefits
of a Management System?
14001
Environmental
 9001 Quality
18001 H&S
19011 Auditing
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Management Systems
Why have a formal Management System?
Improve Quality
Understand Customer Expectations
Ensure safety of Employees
Avoid & Manage Risks
Ensure job security
Reduce Environmental impact
Business & economic growth
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Management Systems
How do you structure a Management System?
Remove checklists
Map processes and/or activities
Create employee involvement
Know and use your resources
Measure stability and effectiveness
Continually improve the Systems
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Management Systems
Who is Involved in the Management System?
Senior Management
Employees must have input and feedback
Internal & External Customers of the
Organization’s processes
What can and cannot be done, is usually a
matter of who is asking the question!
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THE PROCESS APPROACH
Who is W.E. Deming?
Why Japan?
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The Process Approach
Every activity is itself a process, or is a part of a process
A Flow diagram divides the work into stages
Stages as a whole form a process
Stages are not individual entities
A flow diagram, simple or complex, is an example of a theory…an idea!
Stage 1
Stage 2
Stage 3
At every stage there will be –
Production
Continual Improvement
From ‘Out of the Crisis’ by W.E. Deming
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The Process Approach
Design and
Redesign
Suppliers of
Materials /
Equipment
A
Consumer Research
Receipt and
test of
materials
Consumers
Distribution
Production, Assembly, Inspection
B
C
Tests of processes, machines, methods, costs
Production as a process…Japan 1950
From ‘Out of the Crisis’ by W.E. Deming
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WALTER A. SHEWHART
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The Process Approach
The Shewhart Cycle
Study the results. What did
we learn? What can we
predict?
4.
Observe the effects
of the change or test.
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3.
1.
What could be the most important
accomplishment of this team? What
changes might be desirable? What data
are available? Are new observations
needed? If yes, plan a change or test.
Decide how to use the observations.
2.
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Carry out the change or test
decided upon, preferably on
a small scale.
Walter A. Shewhart, ‘Statistical Method from the Viewpoint of Quality Control’, 1939
The Process Approach
The Deming Loop
ACT
PLAN
4.
1.
3.
2.
CHECK
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DO
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Walter A. Shewhart, ‘Statistical Method from the Viewpoint of Quality Control’, 1939
The Process Approach
“The reason to study the results of a change is
to try to learn how to improve tomorrow’s
product,or next year’s crop. Planning requires
prediction. The results of a change or test may
enhance our degree of belief for prediction, for
planning”.
“Step 4 of the Shewhart Cycle…will lead (a) to
improvement of any stage, and (b) to better
satisfaction of the customer for that stage”.
W.E. Deming ‘Out of the Crisis’, 1982
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The Process Approach
Examples of Process Layouts…
< P ro c e s s N a m e >
P ro c e s s F lo w
A c tiv itie s
In p u ts o f p ro c e s s flo w
W h a t a c tio n s a re ta k in g
p la c e
W h e re a re th e y ta k in g
p la c e
C ritic a l m e a s u re s o f
a c tiv ity
D o c u m e n ts in v o lv e d
R e s p o n s ib ilitie s
W h o is d e liv e rin g th e
in p u ts
W h o is re s p o n s ib le
fo r th e a c tiv itie s
W h o is re s p o n s ib le /
s u p e rv is in g th o s e
u n d e rta k in g th e
ta s k s in v o lv e d
W h o is m e a s u rin g
th e p ro c e s s flo w
O th e r p ro c e s s e s
E q u ip m e n t in v o lv e d
W h o is re c e iv in g th e
o u tp u ts
H o w a re a c tiv itie s
c o m p le te d
R e fe re n c e to w o rk
in s tru c tio n s
O u tp u ts o f p ro c e s s flo w
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The Formal
Process (Vertical) Layout
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The Process Approach
The Cross Functional Process Layout
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The Process Approach
A Final Thought on Processes…The Turtle!
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The Process Approach
The Turtle!
Aspects of a Process?
????????????
???
????????????
The Process
????????????
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???
????????????
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The Process Approach
The Turtle
WHAT
Materials and
Equipment
WHO
Competence/Skills/
Training
THE PROCESS
INPUTS
CRITERIA
Measurement /
Assessment
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OUTPUTS
COP’S
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HOW
Methods/Procedures/
Techniques
THE MANAGEMENT SYSTEM
STANDARDS
ISO 9001:2000 & ISO/TS 16949:2002
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The Standards…9001 & TS
ISO 9001:2000 & ISO/TS 16949:2002
Quality Management System Standard
Consolidated 1994 Standards - 9001, 9002, 9003
Applies to all industries including service organizations
TS-Technical Specification
Specifically for the Automotive supply chain…
but also a beefed up 9001:2000
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The Standards…9001 & TS
Founded on the 8 Principles of Management
Focus on your customers
Provide leadership
Involve your people
Use a process approach
Take a systems approach
Encourage continual improvement
Get the facts before you decide
Work with your suppliers
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The Standards…9001 & TS
The Structure
0. Introduction
1. Scope
2. Normative Reference
3. Terms and definitions
4. QMS General Requirements
5. Management Responsibility
6. Resource Management
7. Product Realization
8. Measurement, analysis and improvement
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The Standards…9001 & TS
Introduction – 0.2 Process Approach
“This international standard promotes the
adoption of a process approach when
developing, implementing and improving the
effectiveness of a quality management
system, to enhance customer satisfaction by
meeting customer requirements.”
Promotion of innovation…not prescriptive!
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The Standards…9001 & TS
1. Scope – 1.2 Application
“All requirements of this International Standard
are generic and are intended to be applicable to
all organizations, regardless of type, size and
product provided.”
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The Standards…9001 & TS
4. QMS General Requirements
“…establish, document, implement and
maintain a QMS and continually improve its
effectiveness...”
Documentation - Policy, Manual
(no specific # of documentation required)
Control of documents
Control of records
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The Standards…9001 & TS
5. Management Responsibility
5.1 Management Commitment
“Top management shall provide evidence of
its commitment to the development and
implementation of the QMS…”
Supportive vs. Committed
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The Standards…9001 & TS
6. Resource Management
6.2.2 Competence, awareness and training
“…determine the necessary
competence for personnel
performing work affecting
product quality…”
Trained vs. Competent
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The Standards…9001 & TS
6. Resource Management
6.2.2 Competence, awareness and training
“…are aware of the relevance and importance
of their activities and how they contribute to
the achievement of the quality objectives…”
Knowledge of contribution…
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The Standards…9001 & TS
7. Product Realization
Planning of product realization
Customer Related Processes
Product Requirements
D&D Planning / Review
D&D verification and validation
Purchasing / Supplier Management
Maintenance
Monitoring & Measurement
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The Standards…9001 & TS
8. Measurement, analysis and improvement
8.2.1 Customer Satisfaction
“…the organization shall monitor information
relating to customer perception as to
whether the organization has met customer
requirements.”
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The Standards…9001 & TS
8. Measurement, analysis and improvement
8.4 Analysis of data
“The organization shall determine, collect and
analyze appropriate data to demonstrate the
suitability and effectiveness of the QMS…”
“The reason to study the results of a change is to try to learn
how to improve tomorrow’s product…” W.E. Deming
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The Standards…9001 & TS
8. Measurement, analysis and improvement
8.5.1 Continual Improvement
Vs.
8.5.2 Corrective Action
Vs.
8.5.3 Preventive Action
What is the difference?
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The Standards…9001 & TS
8. Measurement, analysis and improvement
CI – A result of analysis of data, where analysis
demonstrates meeting objectives
CA – A result of an event or problem
PA – A result of analysis of data, where analysis
demonstrates not meeting objectives
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THE MANAGEMENT SYSTEM
STANDARDS
ISO 14001:2004
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The Standards…14001:2004
P la n D o C h e c k A c t
C o n tin u a l Im p ro v e m e n t
M a n a g em en t
E n vir on m en ta l
R eview
P olic y
C h ec kin g
P la n n in g
Im p le m en ta tion &
C on trol
6
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The Standards…14001:2004
The Structure
Introduction
1. Scope
2. Normative References
3. Terms and definitions
4. EMS Requirements
Planning
Implementation & Operation
Checking
Management Review
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The Standards…14001:2004
Introduction
“…based on the methodology known as Plan-DoCheck-Act…Many organizations manage their
operations via the application of a system of
processes and their interactions, which can be
referred to as the process approach…Since PDCA
can be applied to all processes, the two
methodologies are considered to be compatible.”
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The Standards…14001:2004
Terms and Definitions
Environmental Performance – emphasizes process
measurables
CI – recurring process
Nonconformity – non fulfillment of a requirement
Prevention of Pollution – addressed in setting objectives
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The Standards…14001:2004
4.3 Planning
4.3.3 Objectives, targets and programme(s)
No longer two separate elements
“The objectives and targets shall be
measurable,…consistent with the environmental
policy,…and to continual improvement.”
Objective
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Target
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Programme
The Standards…14001:2004
4. EMS Requirements
New
4.1 General Requirements
Added Continual Improvement of EMS – entire
EMS must support CI of EMS and Environmental
Performance
Added Scope of EMS – defined and
documented
Content redesigned to align better with
9001:2000
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The Standards…14001:2004
4.3 Planning
4.3.1 Environmental Aspects
“…ensure that the significant environmental
aspects are taken into account in establishing,
implementing and maintaining its EMS.”
Aspect vs. Impact
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The Standards…14001:2004
4.4 Implementation and operation
New
4.4.2 Competence, training and awareness
“The organization shall ensure that any person(s)
performing tasks for it or on its behalf that have the
potential to cause a significant environmental
impact(s)…are competent on the basis of appropriate
education, training or experience…”
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The Standards…14001:2004
4.4 Implementation and operation
New
4.4.5 Control of Documents
“…ensure that documents of external origin determined by
the organization to be necessary for the planning and
operation of the EMS are identified and their distribution
controlled…”
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The Standards…14001:2004
New
4.5 Checking
4.5.2.2 Evaluation of Compliance
“The organization shall evaluate compliance with
other requirements to which it subscribes.”
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The Standards…14001:2004
4.6 Management Review
New
Added inputs and made more prescriptive:
Results of internal audits
Results of evaluations of compliance
Communications from external parties
Environmental performance
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AUDITING THE MANAGEMENT
SYSTEMS STANDARDS
THE AUDITEE’S PERSPECTIVE
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The Auditee
Documentation-does it keep the system working
Stigma – The TAX MAN cometh!
Pressures
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The Auditee
The Audit – external vs. internal
Dealing with the results
Solving the Root Cause Improvement - How
Cross Functional Problem Solving and Implementation!
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The Auditee
The Audit – external vs. internal
AUDITING THE MANAGEMENT
Dealing
with the results
SYSTEMS
STANDARDS
Solving the Root Cause Improvement
- HowPERSPECTIVE
THE AUDITOR’S
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The Auditor
External Audit – Objective vs. Subjective
Audit trail – linked processes & the turtle
Auditor Secret: Audit the Turtle…if there is
a problem with the system, it will be found
in the turtle!
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The Auditor
Socratic – remove checklists
Evidence – sampling
Evidence of Effectiveness – does the system work?
Think like a manager!
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The Auditor
The Results Nonconformances
Major vs. Minor vs. OFI
Auditor Secret : Keep the bowl of Ice Cream clean!
2 Questions before ruining the Haagen Dazs
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The Auditor
Understand the auditee’s perspective
Auditor Secret : The Auditor creates the
environment!
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TheINAuditor
SUMMARY…
‘Value Added’ Management Systems:
Management Commitment
Employee Involvement
Make lastThought
discussion of Process
Systemic
auditor about the
problem solving
Anticipate
& Control
necessary…evidence
and manager mentality
Prevention & Performance
Erase Stigmas
Think like a manager and focus on Customer Expectations!
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Thank You!
“Training is everything. The peach was once a bitter almond;
cauliflower is nothing but cabbage with a college education.”
Some links…
Mark Twain
Pudd’nhead Wilson (1894)
www.iso.org/
http://www.tc207.org/
www.deming.org/
www.deming.org.uk/
www.isixsigma.com/me/process_management/
www.iaob.org
www.iso.org/tc176/ISO9001AuditingPracticesGroup
http://www.usatoday.com/money/companies/management/2005-12-18-raytheonadvice_x.htm
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